RESUMEN
BACKGROUND: The burden of mortality and morbidity related to pregnancy and childbirth remains concentrated in developing countries. SEA-ORCHID (South East Asia Optimising Reproductive and Child Health In Developing countries) is evaluating whether a multifaceted intervention to strengthen capacity for research synthesis, evidence-based care and knowledge implementation improves adoption of best clinical practice recommendations leading to better health for mothers and babies. In this study we assessed current practices in perinatal health care in four South East Asian countries and determined whether they were aligned with best practice recommendations. METHODOLOGY/PRINCIPAL FINDINGS: We completed an audit of 9550 medical records of women and their 9665 infants at nine hospitals; two in each of Indonesia, Malaysia and The Philippines, and three in Thailand between January-December 2005. We compared actual clinical practices with best practice recommendations selected from the Cochrane Library and the World Health Organization Reproductive Health Library. Evidence-based components of the active management of the third stage of labour and appropriately treating eclampsia with magnesium sulphate were universally practiced in all hospitals. Appropriate antibiotic prophylaxis for caesarean section, a beneficial form of care, was practiced in less than 5% of cases in most hospitals. Use of the unnecessary practices of enema in labour ranged from 1% to 61% and rates of episiotomy for vaginal birth ranged from 31% to 95%. Other appropriate practices were commonly performed to varying degrees between countries and also between hospitals within the same country. CONCLUSIONS/SIGNIFICANCE: Whilst some perinatal health care practices audited were consistent with best available evidence, several were not. We conclude that recording of clinical practices should be an essential step to improve quality of care. Based on these findings, the SEA-ORCHID project team has been developing and implementing interventions aimed at increasing compliance with evidence-based clinical practice recommendations to improve perinatal practice in South East Asia.
Asunto(s)
Servicios de Salud del Niño/normas , Medicina Basada en la Evidencia , Servicios de Salud Materna/normas , Atención Perinatal/normas , Asia Sudoriental , Preescolar , Países en Desarrollo , Femenino , Humanos , Lactante , Parto , Embarazo , Práctica de Salud Pública , TailandiaRESUMEN
BACKGROUND: Respiratory failure due to lung immaturity is a major cause of mortality in preterm infants. Although the use of intermittent positive pressure ventilation (IPPV) in neonates with respiratory failure saves lives, its use is associated with lung injury and chronic lung disease (CLD). Conventional IPPV is provided at 30-80 breaths per minute, while a newer form of ventilation called high frequency oscillatory ventilation (HFOV) provides 'breaths' at 10 - 15 cycles per second. This has been shown to result in less lung injury in experimental studies. OBJECTIVES: The objective of this review is to determine the effect of the elective use of high frequency oscillatory ventilation (HFOV) as compared to conventional ventilation (CV) in preterm infants who are mechanically ventilated for respiratory distress syndrome (RDS), on the incidence of chronic lung disease, mortality and other complications associated with prematurity and assisted ventilation. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching by the Cochrane Collaboration, mainly in the English language. The search was updated in April 2007. SELECTION CRITERIA: Randomised controlled trials comparing HFOV and CV in preterm or low birth weight infants with pulmonary dysfunction, mainly due to RDS, who were given IPPV. Randomisation and commencement of treatment needed to be as soon as possible after the start of IPPV and usually in the first 12 hours of life. DATA COLLECTION AND ANALYSIS: The methodological quality of each trial was independently reviewed by the various authors. The standard effect measures are relative risk (RR) and risk difference (RD). From 1/RD the number needed to treat (NNT) to produce one outcome were calculated. For all measures of effect, 95% confidence intervals were used. In subgroup analyses the 99% CIs are also given for summary RRs in the text. Meta-analysis was performed using a fixed effects model. Where heterogeneity was over 50%, the random effects RR is also given. MAIN RESULTS: Fifteen eligible studies of 3,585 infants were included. Meta-analysis comparing HFOV with CV revealed no evidence of effect on mortality at 28 - 30 days of age or at approximately term equivalent age. These results were consistent across studies and in subgroup analyses. The effect of HFOV on CLD in survivors at term equivalent gestational age was inconsistent across studies and the reduction was of borderline significance overall. Subgroups of trials showed a significant reduction in CLD with HFOV when high volume strategy for HFOV was used, when piston oscillators were used for HFOV, when lung protective strategies for CV were not used, when randomisation occurred at two to six hours of age, and when inspiratory:expiratory ratio of 1:2 was used for HFOV. In the meta-analysis of all trials, pulmonary air leaks occurred more frequently in the HFOV group. In some studies, short-term neurological morbidity with HFOV was found, but this effect was not statistically significant overall. The subgroup of two trials not using a high volume strategy with HFOV found increased rates of Grade 3 or 4 intraventricular haemorrhage and of periventricular leukomalacia. An adverse effect of HFOV on long-term neurodevelopment was found in one large trial but not in the five other trials that reported this outcome. The rate of retinopathy of prematurity is reduced overall in the HFOV group. AUTHORS' CONCLUSIONS: There is no clear evidence that elective HFOV offers important advantages over CV when used as the initial ventilation strategy to treat preterm infants with acute pulmonary dysfunction. There may be a small reduction in the rate of CLD with HFOV use, but the evidence is weakened by the inconsistency of this effect across trials and the overall borderline significance. Future trials on elective HFOV should target those infants who are at most risk of CLD (extremely preterm infants), compare different strategies for generating HFOV and CV, and report important long-term neurodevelopmental outcomes.
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Ventilación de Alta Frecuencia , Enfermedades del Prematuro/prevención & control , Ventilación con Presión Positiva Intermitente , Enfermedades Pulmonares/prevención & control , Enfermedad Crónica , Humanos , Recién Nacido , Recien Nacido Prematuro , Ensayos Clínicos Controlados Aleatorios como Asunto , Síndrome de Dificultad Respiratoria del Recién Nacido/terapiaRESUMEN
BACKGROUND: Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a platelet-derived vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, and low dose aspirin in particular, might prevent or delay the development of pre-eclampsia. OBJECTIVES: To assess the effectiveness and safety of antiplatelet agents when given to women at risk of developing pre-eclampsia, and to those with established pre-eclampsia. SEARCH STRATEGY: This review drew on the search strategy developed for the Pregnancy and Childbirth Group as a whole. The Cochrane Controlled Trials Register was also searched, The Cochrane Library 1999 Issue 1, Embase was searched from 1994-1999 and hand searches were performed of the congress proceedings of the International and European Societies for the Study of Hypertension in Pregnancy. SELECTION CRITERIA: All randomised trials comparing antiplatelet agents with either placebo or no antiplatelet agent during pregnancy. Quasi random study designs were excluded. Participants were pregnant women considered to be at risk of developing pre-eclampsia, and those with pre-eclampsia before delivery. Women treated postpartum were excluded. Interventions were any comparisons of an antiplatelet agent (such as low dose aspirin or dipyridamole) with either placebo or no antiplatelet agent. DATA COLLECTION AND ANALYSIS: Assessment of trials for inclusion in the review and extraction of data was performed independently and unblinded by two reviewers. Data were entered into the Review Manager software and double checked. MAIN RESULTS: Forty two trials involving over 32,000 women were included in this review, with 30,563 women in the prevention trials. There is a 15% reduction in the risk of pre-eclampsia associated with the use of antiplatelet agents [32 trials with 29,331 women; relative risk (RR) 0.85, 95% confidence interval (0.78, 0.92); Number needed to treat (NNT) 89, (59, 167)]. This reduction is regardless of risk status at trial entry or whether a placebo was used, and irrespective of the dose of aspirin or gestation at randomisation.Twenty three trials (28,268 women) reported preterm delivery. There is a small (8%) reduction in the risk of delivery before 37 completed weeks [RR 0.92, (0.88, 0.97); NNT 72 (44, 200)]. Baby deaths were reported in 30 trials (30,093 women). Overall there is a 14% reduction in baby deaths in the antiplatelet group [RR 0.86, (0.75, 0.98); NNT 250 (125, >10000)]. Small for gestational age babies were reported in 25 trials (20,349 women), with no overall difference between the groups, RR 0.92, (0.84, 1.01). There were no significant differences between treatment and control groups in any other measures of outcome. Five trials compared antiplatelet agents with placebo or no antiplatelet agent for the treatment of pre-eclampsia. There are insufficient data for any firm conclusions about the possible effects of these agents when used for treatment of pre-eclampsia. AUTHORS' CONCLUSIONS: Antiplatelet agents, in this review largely low dose aspirin, have small-moderate benefits when used for prevention of pre-eclampsia. Further information is required to assess which women are most likely to benefit, when treatment should be started, and at what dose.
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Aspirina/uso terapéutico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Preeclampsia/tratamiento farmacológico , Femenino , Humanos , Preeclampsia/prevención & control , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, low-dose aspirin in particular, might prevent or delay development of pre-eclampsia. OBJECTIVES: To assess the effectiveness and safety of antiplatelet agents for women at risk of developing pre-eclampsia. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (July 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 1), EMBASE (1994 to November 2005) and handsearched congress proceedings of the International and European Societies for the Study of Hypertension in Pregnancy. SELECTION CRITERIA: All randomised trials comparing antiplatelet agents with either placebo or no antiplatelet agent were included. Quasi-random studies were excluded. Participants were pregnant women at risk of developing pre-eclampsia. Interventions were any comparisons of an antiplatelet agent (such as low-dose aspirin or dipyridamole) with either placebo or no antiplatelet. DATA COLLECTION AND ANALYSIS: Two authors assessed trials for inclusion and extracted data independently. MAIN RESULTS: Fifty-nine trials (37,560 women) are included. There is a 17% reduction in the risk of pre-eclampsia associated with the use of antiplatelet agents ((46 trials, 32,891 women, relative risk (RR) 0.83, 95% confidence interval (CI) 0.77 to 0.89), number needed to treat (NNT) 72 (52, 119)). Although there is no statistical difference in RR based on maternal risk, there is a significant increase in the absolute risk reduction of pre-eclampsia for high risk (risk difference (RD) -5.2% (-7.5, -2.9), NNT 19 (13, 34)) compared with moderate risk women (RD -0.84 (-1.37, -0.3), NNT 119 (73, 333)). Antiplatelets were associated with an 8% reduction in the relative risk of preterm birth (29 trials, 31,151 women, RR 0.92, 95% CI 0.88 to 0.97); NNT 72 (52, 119)), a 14% reduction in fetal or neonatal deaths (40 trials, 33,098 women, RR 0.86, 95% CI 0.76 to 0.98); NNT 243 (131, 1,666) and a 10% reduction in small-for-gestational age babies (36 trials, 23,638 women, RR 0.90, 95% CI0.83 to 0.98). There were no statistically significant differences between treatment and control groups for any other outcomes. AUTHORS' CONCLUSIONS: Antiplatelet agents, largely low-dose aspirin, have moderate benefits when used for prevention of pre-eclampsia and its consequences. Further information is required to assess which women are most likely to benefit, when treatment is best started, and at what dose.
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Inhibidores de Agregación Plaquetaria/uso terapéutico , Preeclampsia/prevención & control , Aspirina/uso terapéutico , Femenino , Muerte Fetal/prevención & control , Humanos , Trabajo de Parto Prematuro/prevención & control , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Mild to moderate hypertension during pregnancy is common. Antihypertensive drugs are often used in the belief that lowering blood pressure will prevent progression to more severe disease, and thereby improve outcome. OBJECTIVES: To assess the effects of antihypertensive drug treatments for women with mild to moderate hypertension during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (March 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2005, Issue 3), MEDLINE (1966 to November 2005), LILACS (1984 to November 2005) and EMBASE (1974 to November 2005). SELECTION CRITERIA: All randomised trials evaluating any antihypertensive drug treatment for mild to moderate hypertension during pregnancy defined, whenever possible, as systolic blood pressure 140 to 169 mmHg and diastolic blood pressure 90 to 109 mmHg. Comparisons were of one or more antihypertensive drug(s) with placebo, with no antihypertensive drug, or with another antihypertensive drug, and where treatment was planned to continue for at least seven days. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. MAIN RESULTS: Forty-six trials (4282 women) were included. Twenty-eight trials compared an antihypertensive drug with placebo/no antihypertensive drug (3200 women). There is a halving in the risk of developing severe hypertension associated with the use of antihypertensive drug(s) (19 trials, 2409 women; relative risk (RR) 0.50; 95% confidence interval (CI) 0.41 to 0.61; risk difference (RD) -0.10 (-0.12 to -0.07); number needed to treat (NNT) 10 (8 to 13)) but little evidence of a difference in the risk of pre-eclampsia (22 trials, 2702 women; RR 0.97; 95% CI 0.83 to 1.13). Similarly, there is no clear effect on the risk of the baby dying (26 trials, 3081 women; RR 0.73; 95% CI 0.50 to 1.08), preterm birth (14 trials, 1992 women; RR 1.02; 95 % CI 0.89 to 1.16), or small-for-gestational-age babies (19 trials, 2437 women; RR 1.04; 95 % CI 0.84 to 1.27). There were no clear differences in any other outcomes. Nineteen trials (1282 women) compared one antihypertensive drug with another. Beta blockers seem better than methyldopa for reducing the risk of severe hypertension (10 trials, 539 women, RR 0.75 (95 % CI 0.59 to 0.94); RD -0.08 (-0.14 to 0.02); NNT 12 (6 to 275)). There is no clear difference between any of the alternative drugs in the risk of developing proteinuria/pre-eclampsia. Other outcomes were only reported by a small proportion of studies, and there were no clear differences. AUTHORS' CONCLUSIONS: It remains unclear whether antihypertensive drug therapy for mild to moderate hypertension during pregnancy is worthwhile.
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Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Complicaciones Cardiovasculares del Embarazo/tratamiento farmacológico , Antihipertensivos/efectos adversos , Femenino , Humanos , Efecto Placebo , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
AIM: To identify antenatal and perinatal risk factors for in-hospital mortality of babies born within the Australian and New Zealand Neonatal Network (ANZNN). METHODS: Data were collected prospectively as part of the ongoing audit of high-risk infants (birth weight <1500 g or gestation <32 weeks) admitted to all level III neonatal units in Australia and New Zealand. Antenatal and intrapartum factors to 1 min of age were examined in 11 498 infants with gestational age >24 weeks. Risk and protective factors for mortality were derived from logistic regression models fitted to 1998-9 data and validated on 2000-1 data. RESULTS: For the whole cohort of infants born between 1998 and 2001, prematurity was the dominant risk factor, infants born at 25 weeks having 32 times greater odds of death than infants born at 31 weeks. Low birth weight for gestational age also had a dose-response effect: the more growth restricted the infant the greater the risk of mortality; infants below the 3rd centile had eight times greater odds of death than those between the 25th and 75th centiles. Male sex was also a significant risk factor (odds ratio (OR) 1.55, 95% confidence interval (CI) 1.31 to 1.82). Maternal hypertension in pregnancy was protective (OR 0.46, 95% CI 0.36 to 0.50). The predictive model for mortality had an area under the receiver operating characteristic curve of 0.82. CONCLUSIONS: Risk of mortality can be predicted with good accuracy with factors up to the 1 min Apgar score. By using gestation rather than birth weight as the main indicator of maturity, these data confirm that weight for gestational age is an independent risk factor for mortality.
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Mortalidad Hospitalaria , Mortalidad Infantil , Recien Nacido Prematuro , Australasia , Peso al Nacer , Femenino , Edad Gestacional , Humanos , Hipertensión/fisiopatología , Recién Nacido de Bajo Peso , Recién Nacido , Masculino , Modelos Estadísticos , Embarazo , Complicaciones Cardiovasculares del Embarazo/fisiopatología , Estudios Prospectivos , Factores de Riesgo , Factores SexualesRESUMEN
BACKGROUND: Very high blood pressure during pregnancy poses a serious threat to women and their babies. Antihypertensive drugs lower blood pressure. Their comparative effects on other substantive outcomes, however, is uncertain. OBJECTIVES: To compare different antihypertensive drugs for very high blood pressure during pregnancy. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (28 February 2006) and CENTRAL (The Cochrane Library 2006, Issue 2). SELECTION CRITERIA: Studies were randomised trials. Participants were women with severe hypertension during pregnancy. Interventions were comparisons of one antihypertensive drug with another. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data. MAIN RESULTS: Twenty-four trials (2949 women) with 12 comparisons were included. Women allocated calcium channel blockers rather than hydralazine were less likely to have persistent high blood (five trials, 263 women; 6% versus 18%; relative risk (RR) 0.33, 95% confidence interval (CI) 0.15 to 0.70). Ketanserin was associated with more persistent high blood pressure than hydralazine (four trials, 200 women; 27% versus 6%; RR 4.79, 95% CI 1.95 to 11.73), but fewer side-effects (three trials, 120 women; RR 0.32, 95% CI 0.19 to 0.53) and a lower risk of HELLP (Haemolysis, Elevated Liver enzymes and Lowered Platelets) syndrome (one trial, 44 women, RR 0.20, 95% CI 0.05 to 0.81). Labetalol was associated with a higher risk of hypotension (one trial 90 women; RR 0.06, 95% CI 0.00 to 0.99) and caesarean section (RR 0.43, 95% CI 0.18 to 1.02) than diazoxide. Data were insufficient for reliable conclusions about other outcomes. The risk of persistent high blood pressure was greater for nimodipine compared to magnesium sulphate (two trials 1683 women; 47% versus 65%; RR 0.84, 95% CI 0.76 to 0.93). Nimodipine was also associated with a higher risk of eclampsia (RR 2.24, 95% CI 1.06 to 4.73) and respiratory difficulties (RR 0.28, 95% CI 0.08 to 0.99), but fewer side-effects (RR 0.68, 95% CI 0.54 to 0.86) and less postpartum haemorrhage (RR 0.41, 95% CI 0.18 to 0.92) than magnesium sulphate. Stillbirths and neonatal deaths were not reported. There are insufficient data for reliable conclusions about the comparative effects of any other drugs. AUTHORS' CONCLUSIONS: Until better evidence is available, the choice of antihypertensive should depend on the clinician's experience and familiarity with a particular drug, and on what is known about adverse effects. Exceptions are diazoxide, ketanserin, nimodipine and magnesium sulphate, which are probably best avoided.
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Antihipertensivos/uso terapéutico , Hipertensión Inducida en el Embarazo/tratamiento farmacológico , Antihipertensivos/efectos adversos , Femenino , Humanos , Preeclampsia/tratamiento farmacológico , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: To identify prenatal risk factors for chronic lung disease (CLD) at 36 weeks postmenstrual age in very preterm infants. POPULATION: Data were collected prospectively as part of the ongoing audit of the Australian and New Zealand Neonatal Network (ANZNN) of all infants born at less than 32 weeks gestation admitted to all tertiary neonatal intensive care units in Australia and New Zealand. METHODS: Prenatal factors up to 1 minute of age were examined in the subset of infants born at gestational ages 22-31 weeks during 1998-2001, and who survived to 36 weeks postmenstrual age (n = 11 453). Factors that were significantly associated with CLD at 36 weeks were entered into a multivariate logistic regression model. RESULTS: After adjustment, low gestational age was the dominant risk factor, with an approximate doubling of the odds with each week of decreasing gestational age from 31 to less than 25 weeks (trend p<0.0001). Birth weight for gestational age also had a dose-response effect: the lower the birth weight for gestational age, the greater the risk, with infants below the third centile having 5.67 times greater odds of CLD than those between the 25th and 75th centile (trend p<0.0001). There was also a significantly increased risk for male infants (odds ratio 1.51 (95% confidence interval 1.36 to 1.68), p<0.0001). CONCLUSIONS: These population based data show that the prenatal factors low gestational age, low birth weight for gestational age, and male sex significantly predict the development of chronic respiratory insufficiency in very preterm infants and may assist clinical decision about delivery.
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Recien Nacido Prematuro , Recién Nacido Pequeño para la Edad Gestacional , Insuficiencia Respiratoria/etiología , Adulto , Peso al Nacer , Enfermedad Crónica , Métodos Epidemiológicos , Femenino , Edad Gestacional , Humanos , Recién Nacido , Masculino , Pronóstico , Insuficiencia Respiratoria/embriología , Factores SexualesRESUMEN
AIM: To analyse variations in rates of severe retinopathy of prematurity (ROP) among neonatal intensive care units (NICUs) in the Australian and New Zealand Neonatal Network (ANZNN), adjusting for sampling variability and for case mix. METHODS: 25 NICUs were included in the study of 2105 infants born at less than 29 weeks in 1998 and 1999, who survived to 36 weeks post-menstrual age and were examined for ROP. The observed NICU rates of severe ROP were adjusted for case mix using logistic regression on gestation, weight for gestational age and sex, and for sampling variability using shrinkage estimates. The corrected rate in the best 20% of NICUs was identified and NICU variations in rates were compared with those in 2000-1. RESULTS: The overall (unadjusted) rate of severe ROP in the NICUs was 9.6% (interquartile range 5.4-12.8%). After adjusting for both case mix and sampling variability there remained significant variation among the NICUs. 20% of NICUs had a rate of severe ROP
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Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Retinopatía de la Prematuridad/epidemiología , Australia/epidemiología , Femenino , Edad Gestacional , Humanos , Recién Nacido , Recien Nacido Prematuro , Cuidado Intensivo Neonatal , Masculino , Nueva Zelanda/epidemiologíaRESUMEN
BACKGROUND: In the past, women have been advised that lowering their salt intake might reduce their risk of developing pre-eclampsia. Although this practice has largely ceased, it remains important to assess the evidence about possible effects of altered dietary salt intake during pregnancy. OBJECTIVES: The objective of this review was to assess the effects of altered dietary salt during pregnancy on the risk of developing pre-eclampsia and its complications. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group Trials Register (8 April 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2005), and EMBASE (2002 to May 2005). SELECTION CRITERIA: Randomised trials evaluating either reduced or increased dietary salt intake during pregnancy. DATA COLLECTION AND ANALYSIS: Two review authors selected trials for inclusion and extracted data independently. Data were entered on Review Manager software for analysis, and double-checked for accuracy. MAIN RESULTS: Two trials were included, with 603 women. Both compared advice to reduce dietary salt intake with advice to continue a normal diet. The confidence intervals were wide and crossed the no-effect line for all the reported outcomes, including pre-eclampsia (relative risk 1.11, 95% confidence interval 0.46 to 2.66). In other words, there was insufficient evidence for reliable conclusions about the effects of advice to reduce dietary salt. AUTHORS' CONCLUSIONS: In the absence of evidence that advice to alter salt intake during pregnancy has any beneficial effect for prevention of pre-eclampsia or any other outcome, salt consumption during pregnancy should remain a matter of personal preference.
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Dieta Hiposódica , Preeclampsia/prevención & control , Cloruro de Sodio Dietético/administración & dosificación , Femenino , Humanos , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Cohort studies (Avery 1987; Jonsson 1997) have suggested that early post-natal nasal continuous positive airways pressure (CPAP) may be beneficial in reducing the need for intubation and intermittent positive pressure ventilation, and in preventing chronic lung disease in preterm or low birth weight infants. OBJECTIVES: To determine if prophylactic nasal CPAP commenced soon after birth regardless of respiratory status in the very preterm or very low birth weight infant reduces the use of IPPV and the incidence of chronic lung disease (CLD) without adverse effects. SEARCH STRATEGY: The search was updated in April 2005. The standard search strategy of the Neonatal Review Group was used. This included searches of the Oxford Database of Perinatal Trials, Cochrane Library Issue 1 2005, MEDLINE 1966-April 2005, previous reviews including cross references, abstracts, conferences, symposia, proceedings, expert informants, journal hand searching mainly in the English language. SELECTION CRITERIA: All trials using random or quasi-random patient allocation of very preterm infants < 32 weeks gestation and / or < 1500 gms at birth were eligible. Comparison had to be between prophylactic nasal CPAP commencing soon after birth regardless of the respiratory status of the infant compared with "standard" methods of treatment where CPAP or IPPV is used for a defined respiratory condition. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration and its Neonatal Review Group, including independent assessment of trial quality and extraction of data by each author, were used. Data were analysed using relative risk (RR). Meta-analysis was performed using a fixed effects model. MAIN RESULTS: There are no statistically significant differences in any of the outcomes studied in either of the eligible trials (Han 1987; Sandri 2004) reporting on 82 and 230 infants respectively. In Han 1987 there are trends towards increases in the incidence of BPD at 28 days [RR 2.27 (0.77, 6.65)], death [RR 3.63 (0.42, 31.08)] and any IVH [RR 2.18 (0.84, 5.62)] in the CPAP group. In Sandri 2004 there is a trend towards an increase in IVH grade 3 or 4 [RR 3.0 (0.96, 28.42)] in the CPAP group. No outcome was significantly different in any of the meta-analyses. AUTHORS' CONCLUSIONS: There is currently insufficient information to evaluate the effectiveness of prophylactic nasal CPAP in very preterm infants. Neither of the included studies reviewed showed evidence of benefit in reducing the use of IPPV. The tendency for some adverse outcomes to be increased is of concern and further multicentre randomized controlled trials are needed to clarify this.
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Enfermedades del Prematuro/prevención & control , Enfermedades Pulmonares/prevención & control , Respiración con Presión Positiva , Enfermedad Crónica , Humanos , Recién Nacido de Bajo Peso , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/mortalidadRESUMEN
BACKGROUND: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia which may be severe enough to require resuscitation including use of positive pressure ventilation. Doxapram has been used to stimulate breathing and so prevent apnea and its consequences. OBJECTIVES: In preterm infants with recurrent apnea, does treatment with Doxapram lead to a clinically important reduction in apnea and use of intermittent positive airways pressure (IPPV), without clinically important side effects? SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal trials, the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 3, 2004), MEDLINE from 1966 - June 2004, EMBASE from 1980 - June 2001, CINAHL from 1982- June 2004. Text words 'doxapram', 'apnea or apnoea' and the MeSH term 'infant, premature' were used. Previous reviews including cross references, abstracts from conferences and symposia proceedings were also examined. Abstracts of the Society for Pediatric Research were searched from 1996 - 2004 inclusive. SELECTION CRITERIA: All trials utilising random or quasi-random patient allocation, in which doxapram was used for the treatment of apnea in preterm infants were included. DATA COLLECTION AND ANALYSIS: Each author evaluated the papers for quality and inclusion criteria. Independent data extraction was carried out. MAIN RESULTS: Only one trial, which randomized 11 infants to intravenous doxapram and 10 infants to placebo, was found. There were fewer treatment failures after 48 hours in the group of preterm infants treated with doxapram (4/11) compared with the group treated with placebo (8/10). The wide confidence intervals made this result non-significant [RR 0.45 (0.20, 1.05)]. Only one infant, who was from the placebo group, was given IPPV. Of the seven responders by 48 hours in the group of 11 who received doxapram, five failed to respond between 48 hours and seven days after commencement of therapy. This gives a late failure rate of 9/11, similar to the short term failure rate in the placebo group of 8/10. It is not possible to evaluate the late responses of all those in the placebo group since they crossed over to a treatment arm. REVIEWERS' CONCLUSIONS: Although intravenous Doxapram might reduce apnea within the first 48 hours of treatment, there are insufficient data to evaluate the precision of this result or to assess potential adverse effects. No long term outcomes have been measured. Further studies are needed to determine the role of this treatment in clinical practice.
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Apnea/tratamiento farmacológico , Doxapram/uso terapéutico , Enfermedades del Prematuro/tratamiento farmacológico , Fármacos del Sistema Respiratorio/uso terapéutico , Aminofilina/uso terapéutico , Humanos , Recién Nacido , Recien Nacido PrematuroRESUMEN
OBJECTIVE: To compare two dosing regimens for caffeine citrate in the periextubation period for neonates born at less than 30 weeks gestation in terms of successful extubation and adverse effects. DESIGN: A multicentre, randomised, double blind, clinical trial. SETTING: Four tertiary neonatal units within Australia. PATIENTS: Infants born less than 30 weeks gestation ventilated for more than 48 hours. INTERVENTIONS: Two dosing regimens of caffeine citrate (20 v 5 mg/kg/day) for periextubation management. Treatment started 24 hours before a planned extubation or within six hours of an unplanned extubation. MAIN OUTCOME MEASURE: Failure to extubate within 48 hours of caffeine loading or reintubation and ventilation or doxapram within seven days of caffeine loading. RESULTS: A total of 234 neonates were enrolled. A significant reduction in failure to extubate was shown for the 20 mg/kg/day dosing group (15.0% v 29.8%; relative risk 0.51; 95% confidence interval (CI) 0.31 to 0.85; number needed to treat 7 (95% CI 4 to 24)). A significant difference in duration of mechanical ventilation was shown for infants of less than 28 weeks gestation receiving the high dose of caffeine (mean (SD) days 14.4 (11.1) v 22.1 (17.1); p = 0.01). No difference in adverse effects was detected in terms of mortality, major neonatal morbidity, death, or severe disability or general quotient at 12 months. CONCLUSIONS: This trial shows short term benefits for a 20 mg/kg/day dosing regimen of caffeine citrate for neonates born at less than 30 weeks gestation in the periextubation period, without evidence of harm in the first year of life.
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Cafeína/administración & dosificación , Citratos/administración & dosificación , Respiración Artificial/métodos , Cafeína/efectos adversos , Citratos/efectos adversos , Método Doble Ciego , Doxapram/administración & dosificación , Combinación de Medicamentos , Femenino , Edad Gestacional , Humanos , Recién Nacido , Recien Nacido Prematuro/fisiología , Masculino , Fármacos del Sistema Respiratorio/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento , Desconexión del VentiladorRESUMEN
OBJECTIVE: To examine trends in preterm births, especially those less than 33 weeks gestation, occurring in perinatal centres in New South Wales (NSW) from 1992 to 2001. METHODS: Population data were obtained from the NSW Midwives' Data Collection. Trends in the proportion of births in perinatal centres by gestation and by type of preterm birth (spontaneous or elective), and in Apgar scores and neonatal mortality were determined. RESULTS: The preterm birth rate increased from 6.1% in 1992 to 6.7% in 2001. Factors contributing to the increase in preterm births were multiple births and elective preterm deliveries. Births less than 33 weeks gestation in perinatal centres increased from 76% to 83% and for multiple births from 77% to 87%. This coincided with a decrease in 1-minute Apgar scores less than 4 but no significant change in 5-minute Apgar scores or neonatal mortality. CONCLUSIONS: Progress has been made towards the National Health and Medical Research Council guideline that births less than 33 weeks gestation occur in perinatal centres. Preterm births are increasing, creating greater demands for neonatal intensive care unit care and ventilation services.
Asunto(s)
Mortalidad Infantil/tendencias , Recien Nacido Prematuro , Puntaje de Apgar , Femenino , Humanos , Recién Nacido , Nueva Gales del Sur , Embarazo , Resultado del EmbarazoRESUMEN
BACKGROUND: Pre-eclampsia is associated with deficient intravascular production of prostacyclin, a vasodilator, and excessive production of thromboxane, a platelet-derived vasoconstrictor and stimulant of platelet aggregation. These observations led to the hypotheses that antiplatelet agents, low-dose aspirin in particular, might prevent or delay the development of pre-eclampsia. OBJECTIVES: To assess the effectiveness and safety of antiplatelet agents when given to women at risk of developing pre-eclampsia. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (September 2003), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2003), EMBASE (1994 to 2003) and we handsearched the congress proceedings of the International and European Societies for the Study of Hypertension in Pregnancy. SELECTION CRITERIA: All randomised trials comparing antiplatelet agents with either placebo or no antiplatelet agent during pregnancy. Quasi-random study designs were excluded. Participants were pregnant women considered to be at risk of developing pre-eclampsia. Interventions were any comparisons of an antiplatelet agent (such as low-dose aspirin or dipyridamole) with either placebo or no antiplatelet agent. DATA COLLECTION AND ANALYSIS: Two reviewers assessed trials for inclusion in the review and extracted data. We entered data into the Review Manager software and double checked. MAIN RESULTS: Fifty-one trials involving 36,500 women are included in this review. There is a 19% reduction in the risk of pre-eclampsia associated with the use of antiplatelet agents ((43 trials, 33,439 women; relative risk (RR) 0.81, 95% confidence interval (CI) 0.75 to 0.88); number needed to treat (NNT) 69 (51, 109)).Twenty-eight trials (31,845 women) reported preterm birth. There is a small (7%) reduction in the risk of delivery before 37 completed weeks ((RR 0.93, 95% CI 0.89 to 0.98); NNT 83 (50, 238)). Fetal or neonatal deaths were reported in 38 trials (34,010 women). Overall there is a 16% reduction in baby deaths in the antiplatelet group (RR 0.84, 95% CI 0.74 to 0.96); NNT 227 (128, 909)). Small-for-gestational age babies were reported in 32 trials (24,310 women), with an 8% reduction in risk (RR 0.92, 95% CI 0.85 to 1.00). There were no significant differences between treatment and control groups in any other measures of outcome. REVIEWER'S CONCLUSIONS: Antiplatelet agents, in this review largely low-dose aspirin, have small-moderate benefits when used for prevention of pre-eclampsia. Further information is required to assess which women are most likely to benefit, when treatment is best started, and at what dose.
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Inhibidores de Agregación Plaquetaria/uso terapéutico , Preeclampsia/prevención & control , Femenino , Humanos , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Respiratory failure due to lung immaturity is a major cause of mortality in preterm infants. Although intermittent positive pressure ventilation (IPPV) saves lives, lung distortion during its use is associated with lung injury and chronic lung disease (CLD). Conventional IPPV is provided at 30-80 breaths per minute while a newer form of ventilation called high frequency oscillatory ventilation (HFOV) provides 'breaths' at 10-15 cycles per second. This has been shown to result in less lung injury in experimental studies. OBJECTIVES: The objective of this review is to determine whether the elective use of high frequency oscillatory ventilation as compared to conventional ventilation (CV) in preterm infants who are mechanically ventilated for the respiratory distress syndrome decreases the incidence of chronic lung disease, without adverse effects. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal hand searching by the Cochrane Collaboration, mainly in the English language. The search was updated in May 2003. SELECTION CRITERIA: Randomized controlled trials comparing HFOV and CV in preterm or low birth weight infants with pulmonary dysfunction, mainly due to RDS, who are to be given IPPV. Randomization and commencement of treatment should have been as soon as possible after the start of IPPV and usually in the first 12 hours of life. DATA COLLECTION AND ANALYSIS: The methodological quality of each trial was independently reviewed by the various authors. Each author extracted data separately; they were compared and differences were resolved. Treatment effects were expressed using relative risk (RR) and risk difference (RD). From 1/RD the number needed to treat (NNT) to produce one outcome were calculated. Ninety five percent confidence intervals were used for all measures of effect. MAIN RESULTS: Eleven eligible studies on 3,275 infants were included. Meta-analysis comparing HFOV with CV revealed no evidence of effect on mortality at 28-30 days of age or at approximately term equivalent age. These results were consistent across studies. The effect of HFOV on CLD in survivors at term equivalent GA was inconsistent across studies and not significant overall. Pre-specified subgroup analyses according to use of a high volume strategy, or use of surfactant, did not identify subgroups in which there was evidence of effect on death, or in which the size of effect on CLD was substantially increased, or in which heterogeneity of treatment effect on CLD was removed. Short term neurological morbidity caused by HFOV was found in some studies, but this effect was not statistically significant overall. The subgroup of two trials not using a high volume strategy with HFOV found increased rates of Grade 3 or 4 IVH and of periventricular leukomalacia. An adverse effect of HFOV on longer term neurodevelopment was found in one large trial but not in two other small trials which reported this outcome. REVIEWER'S CONCLUSIONS: There is no clear evidence from this systematic review that elective HFOV, as compared with CV, offers important advantages when used as the initial ventilation strategy to treat preterm babies with acute pulmonary dysfunction. There is no evidence of a reduction in death rate. There may be a small reduction in the rate of CLD with HFOV use but the evidence is weakened by the inconsistency of this effect across trials and is not significant overall. Adverse effects on short term neurological outcomes have been observed in some studies but these effects are not significant overall. Information about effects on long term outcome is not adequate overall. Any future trials on elective HFOV should target those infants who are at most risk of CLD (extremely preterm), compare different strategies for generating HFOV and CV, and report important long term pulmonary and neurodevelopmental outcomes. Economic analysis should also be incorporated.
Asunto(s)
Ventilación de Alta Frecuencia , Enfermedades del Prematuro/prevención & control , Ventilación con Presión Positiva Intermitente , Enfermedades Pulmonares/prevención & control , Enfermedad Crónica , Humanos , Recién Nacido , Recien Nacido Prematuro , Ensayos Clínicos Controlados Aleatorios como Asunto , Síndrome de Dificultad Respiratoria del Recién Nacido/terapiaRESUMEN
BACKGROUND: Eclampsia, the occurrence of a convulsion in association with pre-eclampsia, remains a rare but serious complication of pregnancy. A number of different anticonvulsants are used to control eclamptic fits and to prevent further fits. OBJECTIVES: The objective of this review was to assess the effects of magnesium sulphate compared with diazepam when used for the care of women with eclampsia. Magnesium sulphate is compared with phenytoin and with lytic cocktail in other Cochrane reviews. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth trials register (28 November 2002) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002). SELECTION CRITERIA: Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with diazepam for women with a clinical diagnosis of eclampsia. DATA COLLECTION AND ANALYSIS: Both reviewers assessed and extracted data. MAIN RESULTS: Seven trials involving 1441 women are included. Most of the data are from trials of good quality. Magnesium sulphate is associated with a reduction in maternal death when compared to diazepam (six trials 1336 women; relative risk (RR) 0.59, 95% confidence interval (CI) 0.37 to 0.94). There is also a substantial reduction in the risk recurrence of further fits (seven trials 1441 women; RR 0.44, 95% CI 0.34 to 0.57). There were few differences in any other measures of outcome, except for fewer Apgar scores less than seven at five minutes (two trials 597 babies; RR 0.72, 95% CI 0.55 to 0.94) and fewer babies with a length of stay in special care baby unit more than seven days (three trials 631 babies; RR 0.66, 95% CI 0.46 to 0.95) associated with magnesium sulphate. REVIEWER'S CONCLUSIONS: Magnesium sulphate appears to be substantially more effective than diazepam for treatment of eclampsia.
Asunto(s)
Anticonvulsivantes/uso terapéutico , Diazepam/uso terapéutico , Eclampsia/tratamiento farmacológico , Sulfato de Magnesio/uso terapéutico , Femenino , Humanos , Embarazo , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Eclampsia, the occurrence of a convulsion (fit) in association with pre-eclampsia, remains a rare but serious complication of pregnancy. A number of different anticonvulsants are used to control eclamptic fits and to prevent further convulsions. OBJECTIVES: The objective of this review was to assess the effects of magnesium sulphate compared with phenytoin when used for the care of women with eclampsia. Magnesium sulphate is compared with diazepam and with lytic cocktail in other Cochrane reviews. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth trials register (28 November 2002) and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2002). SELECTION CRITERIA: Randomised trials comparing magnesium sulphate (intravenous or intramuscular administration) with phenytoin for women with a clinical diagnosis of eclampsia. DATA COLLECTION AND ANALYSIS: Both reviewers assessed trial quality and extracted data. MAIN RESULTS: Six trials involving 897 women are included. Most of the data are from trials of good quality. Magnesium sulphate is associated with a substantial reduction in the recurrence of convulsions, when compared to phenytoin (five trials, 895 women; relative risk (RR) 0.31, 95% confidence interval (CI) 0.20 to 0.47). The trend in maternal mortality favours magnesium sulphate, but this difference is not statistically significant (two trials, 797 women; RR 0.50, 95% CI 0.24 to 1.05). There are also reductions in the risk of pneumonia (RR 0.44, 95% CI 0.24 to 0.79), ventilation (RR 0.66, 95% CI 0.49 to 0.90) and admission to an intensive care unit (RR 0.67, 95% CI 0.50 to 0.89) associated with the use of magnesium sulphate. For the baby, magnesium sulphate was associated with fewer admissions to a special care baby unit (SCBU) (one trial, 518 babies; RR 0.73, 95% CI 0.58 to 0.91) and fewer babies who died or were in SCBU for more than seven days (one trial, 665 babies; RR 0.77, 95% CI 0.63 to 0.95). REVIEWER'S CONCLUSIONS: Magnesium sulphate appears to be substantially more effective than phenytoin for treatment of eclampsia.
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Anticonvulsivantes/uso terapéutico , Eclampsia/tratamiento farmacológico , Sulfato de Magnesio/uso terapéutico , Fenitoína/uso terapéutico , Clorpromazina/uso terapéutico , Combinación de Medicamentos , Femenino , Humanos , Meperidina/uso terapéutico , Embarazo , Prometazina/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVE: To examine the variation between hospitals in rates of severe intraventricular haemorrhage (IVH) in preterm babies adjusting for case mix and sampling variability. DESIGN: Cross sectional study of pooled data from 1995 to 1997. SETTING: 24 neonatal intensive care units (NICUs) in the Australian and New Zealand Neonatal Network. PARTICIPANTS: 5413 infants of gestational age 24-30 weeks. MAIN OUTCOME MEASURES: Crude rates of severe (grades 3 and 4) IVH and rates adjusted for case mix using logistic regression, and for sampling variability using shrinkage estimators. RESULTS: The overall rate of severe IVH was 6.8%, but crude rates for individual units ranged from 2.9 to 21.4%, with interquartile range (IQR) 5.7-8.1%. Adjusting for the five significant predictor variables--gestational age at birth, 1 minute Apgar score, antenatal corticosteroids, transfer after birth, and sex--actually increased the variability in rates (IQR 5.9-9.7%). Shrinkage estimators, which adjust for differences in unit sizes and outcome rates, reduced the variation in rates (IQR 6.3-7.5%). Adjusting for case mix and using shrinkage estimators showed that one unit had a significantly higher adjusted rate than expected, while another was significantly lower. If all units could achieve an average rate equal to the 20th centile (5.74%), then 60 cases of severe IVH could be prevented in a 3 year period. CONCLUSIONS: The use of shrinkage estimators may have a greater impact on the variation in outcomes between hospitals than adjusting for case mix. Greater reductions in morbidity may be achieved by concentrating on the best rather than the worst performing hospitals.
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Hemorragia Cerebral/epidemiología , Hospitales Públicos/estadística & datos numéricos , Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Resultado del Tratamiento , Australia/epidemiología , Hemorragia Cerebral/terapia , Ventrículos Cerebrales/patología , Estudios Transversales , Femenino , Investigación sobre Servicios de Salud , Hospitales Públicos/normas , Humanos , Recién Nacido , Recien Nacido Prematuro , Nueva Zelanda/epidemiologíaRESUMEN
BACKGROUND: Preterm infants are at risk of periventricular haemorrhage. Phenobarbital might prevent ischaemic injury or reduce fluctuations in blood pressure and blood flow in the brain. OBJECTIVES: To assess the benefits and harms of giving phenobarbital to women at risk of imminent very preterm birth with the primary aim of preventing periventricular haemorrhage in the infant. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (18 October 2002), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1, 2003) and bibliographies. SELECTION CRITERIA: Randomised trials with reported data that compare outcomes, such as neonatal mortality, neonatal neurological and other morbidity, long-term neurodevelopment and maternal morbidity, following prenatal exposure to phenobarbital, with outcomes in controls with or without placebo. DATA COLLECTION AND ANALYSIS: We independently assessed trial eligibility and quality and extracted data. We included eligible trials in the initial analysis and prespecified sensitivity analyses to evaluate the effect of trial quality. Results are expressed as relative risk (RR) and 95% confidence intervals (CI). MAIN RESULTS: Over 1750 women were entered into the nine trials included. Analyses of all included trials showed a significant reduction in the rates of all grades of periventricular haemorrhage (PVH) (RR 0.65, 95% CI 0.50 to 0.83, 9 trials, 1591 women) and severe grades PVH (3 and 4) (RR 0.41, 95% CI 0.20 to 0.85, 8 trials, 1527 women) in infants whose mothers had been given prenatal phenobarbital. These results were influenced by trials of poor quality which contributed excessive weight in the analysis due to their higher rates of severe PVH. When only the two higher quality trials were included, these beneficial effects disappeared for all grades of PVH (RR 0.90, 95% CI 0.75 to 1.08, 2 trials, 945 women), and severe grades of PVH (RR 1.05, 95% CI 0.60 to 1.83, 2 trials, 945 women). No difference was found in the incidence of neurodevelopmental abnormalities at paediatric follow up assessed between 18 to 36 months of age. Maternal sedation was more likely in women receiving phenobarbital (RR 2.06, 95% CI 1.79 to 2.37, 1 trial, 576 women). REVIEWER'S CONCLUSIONS: The evidence in this review does not support the use of prophylactic maternal phenobarbital administration to prevent periventricular haemorrhage or to protect from neurological disability in preterm infants. Phenobarbital administration leads to maternal sedation. If any future trials are carried out, they should measure neurodevelopmental status at follow up.