RESUMEN
OBJECTIVE: To investigate the association of PRBC transfusion and the development of NEC in VLBW preterm infants at a tertiary care neonatal unit. METHODS: A retrospective case-control study was performed. All VLBW infants (gestational age ≤32 week and birth weight <1500 g) born between 1999 and 2013 were included. Cases and controls were divided into four groups: (1) Infants who received PRBC transfusion and developed NEC within 48 hours of transfusion; (2) Infants who received PRBC transfusion and did not develop NEC; (3) Infant who developed NEC and did not receive PRBC transfusion; and (4) Infants who neither developed NEC nor received PRBC transfusion. Our primary outcome was the association of PRBC transfusion with the development of severe NEC. RESULTS: One hundred fifty two VLBW infants were enrolled. The mean birth weight of enrolled infants was 1042 g and a mean gestational age of 28 weeks. The included four groups were not statistically different with regard to baseline important variables. Infants who had NEC and received PRBC transfusion (group 1) had higher incidence of sepsis and severe retinopathy of prematurity. Overall, Infants who received PRBC transfusion had a lower incidence of NEC (OR 0.39, 95% CI: 0.18,0.84, p = 0.02). CONCLUSION: We observed a lower association of PRBC transfusion and severe NEC in VLBW infants. Prospective, randomized well powered studies are needed to confirm our findings.
Asunto(s)
Enterocolitis Necrotizante/etiología , Transfusión de Eritrocitos , Enfermedades del Prematuro/etiología , Recién Nacido de muy Bajo Peso , Estudios de Casos y Controles , Enterocolitis Necrotizante/epidemiología , Enterocolitis Necrotizante/prevención & control , Transfusión de Eritrocitos/efectos adversos , Femenino , Humanos , Incidencia , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/epidemiología , Enfermedades del Prematuro/prevención & control , Masculino , Estudios Retrospectivos , Factores de Riesgo , Resultado del TratamientoRESUMEN
Probiotics are live microbial feed supplements that beneficially affect the recipient by improving intestinal balance. In an updated systematic review, nineteen trials randomizing more than 2800 infants were included. In a meta-analysis of trial data, enteral probiotic supplementation significantly reduced the incidence of severe necrotizing enterocolitis (typical RR 0.35, 95% CI 0.24 to 0.52) and mortality (typical RR 0.55, 95% CI 0.40 to 0.74). There was no evidence of significant reduction of nosocomial sepsis (typical RR 0.89, 95% CI 0.77 to 1.03). The included trials reported no systemic infection with - supplemented probiotics. Recent data in addition to a report by the European Society for Pediatric Gastroenterology (ESPGAN) concluded probiotics could be generally considered safe.
Asunto(s)
Suplementos Dietéticos , Enterocolitis Necrotizante/prevención & control , Enfermedades del Prematuro/prevención & control , Probióticos , Sepsis/prevención & control , Enterocolitis Necrotizante/dietoterapia , Enterocolitis Necrotizante/mortalidad , Femenino , Humanos , Incidencia , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/dietoterapia , Enfermedades del Prematuro/mortalidad , Infusiones Parenterales/métodos , Masculino , Metaanálisis como Asunto , Probióticos/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Sepsis/dietoterapia , Sepsis/mortalidad , Resultado del TratamientoRESUMEN
UNLABELLED: Important short-term intermediate outcomes such as patent ductus arteriosus (PDA), severe intraventricular haemorrhage, surgical ligation of PDA and serious pulmonary haemorrhage correlate with worse neurosensory outcomes in extreme low birth weight infants. Indomethacin prophylaxis has been shown to significantly prevent such outcomes. However, this positive effect did not translate into neither prevention of bronchopulmonary dysplasia nor long-term neurosensory outcome. The indomethacin prophylaxis story is indeed a puzzling one to neonatal practitioners. We present a summary of evidence and possible explanations to the lack of appreciated long-term effect of indomethacin prophylaxis. As the trial of indomethacin prophylaxis for preterms trial is a major contributor to current evidence, a detailed critical analysis of its methodology is presented. Methodological concerns such as the use of a composite outcome, statistical power, anticipated side effects of indomethacin prophylaxis and lack of predictive validity of cognitive delay measurements are presented. CONCLUSION: Conclusive evidence of indomethacin prophylaxis use in extreme low birth weight infants is still lacking. Future research should put more emphasis on parental preferences, synergistic effect of indomethacin prophylaxis and fluid restriction and early targeted approach to PDA management.
Asunto(s)
Antiinflamatorios no Esteroideos/uso terapéutico , Fármacos Cardiovasculares/uso terapéutico , Conducto Arterioso Permeable/prevención & control , Indometacina/uso terapéutico , Recien Nacido con Peso al Nacer Extremadamente Bajo , Antiinflamatorios no Esteroideos/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Ensayos Clínicos como Asunto , Medicina Basada en la Evidencia , Humanos , Indometacina/efectos adversos , Recién Nacido , Pautas de la Práctica en Medicina/tendenciasRESUMEN
OBJECTIVE: To evaluate the efficacy and safety of remifentanil as a premedication in neonates undergoing elective endotracheal intubation. DESIGN: A double-blind randomised controlled trial. SETTING: Tertiary care neonatal intensive care unit. PATIENTS: Haemodynamically stable term and preterm neonates requiring elective endotracheal intubation. INTERVENTIONS: Infants in the intervention arm received remifentanil (3 microg/kg) and normal saline placebo. The control group received fentanyl (2 microg/kg) and succinylcholine (2 mg/kg). Both groups also received atropine (20 microg/kg) as part of the premedication regime. MAIN OUTCOME MEASURES: The primary outcome was time to successful intubation. Secondary outcomes included time to return of spontaneous respirations, oxygen saturation, heart rate and blood pressure changes during the procedure, adverse events and a survey of intubation conditions. RESULTS: A total of 15 infants were randomised to each group. Baseline characteristics were similar in both groups. The median time to successful intubation was not statistically different (247 s in the remifentanil group vs 156 s in the fentanyl group, p=0.88). The intubation conditions were rated more favourably with fentanyl by the intubators. Although not statistically significant, chest wall rigidity was observed more commonly with remifentanil. CONCLUSIONS: Although remifentanil is comparable to fentanyl and succinylcholine in attenuating adverse physiologic responses during neonatal intubation, muscle rigidity is a concern at doses of 3 microg/kg. Further trials are required to evaluate ideal dosing regimens and combinations of agents for use with remifentanil in neonates.
Asunto(s)
Analgésicos Opioides/uso terapéutico , Intubación Intratraqueal/métodos , Piperidinas/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Insuficiencia Respiratoria/terapia , Método Doble Ciego , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Cuidado Intensivo Neonatal , Masculino , Premedicación , Remifentanilo , Síndrome de Dificultad Respiratoria del Recién Nacido/complicaciones , Insuficiencia Respiratoria/etiologíaRESUMEN
BACKGROUND: Necrotizing enterocolitis (NEC) and nosocomial sepsis are associated with increased morbidity and mortality in preterm infants. Through prevention of bacterial migration across the mucosa, competitive exclusion of pathogenic bacteria, and enhancing the immune responses of the host, prophylactic enteral probiotics (live microbial supplements) may play a role in reducing NEC and associated morbidity. OBJECTIVES: To compare the efficacy and safety of prophylactic enteral probiotics administration versus placebo or no treatment in the prevention of severe NEC and/or sepsis in preterm infants. SEARCH STRATEGY: The standard search strategy for the Cochrane Neonatal Review Group was performed by two review authors. Searches were made of MEDLINE (1966 to December 2006), EMBASE (1980 to December 2006), Cochrane Library Controlled Trials Register (CENTRAL, The Cochrane Library Issue 3, 2006), and abstracts of annual meetings of the Society for Pediatric Research (1995 - 2006). The authors of published articles were contacted. SELECTION CRITERIA: Only randomized or quasi-randomized controlled trials that enrolled preterm infants < 37 weeks gestational age and/or < 2500 g birth weight were considered. Trials were included if they involved enteral administration of any live microbial supplement (probiotics) and measured at least one prespecified clinical outcome. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration and its Neonatal Group were used to assess the methodologic quality of the trials. Retrieved articles were assessed for eligibility and data abstracted independently by two review authors. Where data were incomplete, the primary investigator were contacted for further information and clarification. Where appropriate, data of individual trials were combined using meta-analytic techniques to provide a pooled estimate of effect assuming a fixed effect model. MAIN RESULTS: Nine eligible trials randomizing 1425 infants were included. Included trials were highly variable with regard to enrollment criteria (i.e. birth weight and gestational age), baseline risk of NEC in the control groups, timing, dose, formulation of the probiotics, and feeding regimens. Data regarding extremely low birth weight infants (ELBW) could not be extrapolated. In a meta-analysis of trial data, enteral probiotics supplementation significantly reduced the incidence of severe NEC (stage II or more) [typical RR 0.32 (95% CI 0.17, 0.60)] and mortality [typical RR 0.43 (95% CI 0.25, 0.75]. There was no evidence of significant reduction of nosocomial sepsis [typical RR 0.93 (95% CI 0.73, 1.19)] or days on total parenteral nutrition (TPN) [WMD -1.9 (95% CI -4.6, 0.77)]. The included trials reported no systemic infection with the probiotics supplemental organism. The statistical test of heterogeneity for NEC, mortality and sepsis was insignificant. AUTHORS' CONCLUSIONS: Enteral supplementation of probiotics reduced the risk of severe NEC and mortality in preterm infants. This analysis supports a change in practice in premature infants > 1000 g at birth. Data regarding outcome of ELBW infants could not be extracted from the available studies; therefore, a reliable estimate of the safety and efficacy of administration of probiotic supplements cannot be made in this high risk group. A large randomized controlled trial is required to investigate the potential benefits and safety profile of probiotics supplementation in ELBW infants.
Asunto(s)
Enterocolitis Necrotizante/prevención & control , Probióticos/uso terapéutico , Humanos , Recién Nacido , Recien Nacido Prematuro , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Patent ductus arteriosus (PDA) is associated with increased mortality and morbidity in preterm infants. Prophylactic indomethacin results in favorable intermediate outcomes such as reduction of significant PDA, need for surgical ligation, severe intraventricular hemorrhage and serious pulmonary hemorrhage without modifying long-term neurosensory outcomes. Little is known about the effectiveness and safety of prophylactic surgical closure of the PDA in extremely low birth weight (ELBW) infants. OBJECTIVES: To identify and summarize evidence from randomized controlled trials investigating the effectiveness and safety of prophylactic surgical ligation of the PDA on mortality and morbidities of preterm infants less than 1000 g at birth as compared to no prophylaxis or prophylactic cyclooxygenase inhibitors. SEARCH STRATEGY: The standard search strategy for the Cochrane Neonatal Review Group was performed by two review authors. Searches were made of MEDLINE (1966 to December 2006), EMBASE (1980 to December 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), and abstracts of annual meetings of the Society for Pediatric Research (1995 - 2006). Contacts were made with the authors of published articles. SELECTION CRITERIA: Randomized or quazi-randomized controlled trials that enrolled infants less than 28 weeks gestation or less than 1000 g at birth who are on assisted ventilation and/or supplemental oxygen without clinical signs of hemodynamic significance of the ductus arteriosus were considered. Trials addressing prophylactic surgical ligation of the patent ducts arteriosus (i.e. procedure done during the first 72 hours of life) versus no intervention or cyclooxygenase inhibitor prophylaxis were included. The primary outcome was bronchopulmonary dysplasia (BPD). Other important short and long-term neonatal outcomes were also considered. DATA COLLECTION AND ANALYSIS: Standard methods of the Cochrane Collaboration and its Neonatal Review Group were used to assess the methodologic quality of the trials. Retrieved articles were assessed for eligibility and data was abstracted independently by two reviewer authors. Where data were incomplete, the primary investigators were contacted for further information and clarifications. For dichotomous outcomes, relative risk (RR) and its associated confidence interval were calculated. For continuous outcomes, treatment effect was expressed as mean difference and its calculated standard deviation. When appropriate, meta-analysis of pooled data was performed assuming a fixed effect model MAIN RESULTS: Only one eligible study that enrolled 84 ELBW infants was identified. The prophylactic group had ductal ligation performed within 24 hours of life following a pre-specified protocol, while the control group received standard care without indomethacin. Prophylactic surgical ligation of the PDA resulted in a statistically significant reduction of severe stage II or III necrotizing enterocolitis (NEC), [RR 0.25, 95% CI (0.08,0.83), p value 0.02, NNT 5]. The study found no statistically significant difference in mortality, severe grade III and IV intraventricular hemorrhage (IVH), BPD, and retinopathy of prematurity (ROP). Of note, the study was unblinded and underpowered to detect clinically important differences in the above mentioned outcomes. AUTHORS' CONCLUSIONS: Prophylactic surgical ligation of the PDA did not decrease mortality or BPD in ELBW infants. A significant reduction of stage II or III NEC was noted. Based on the current evidence, the high rate of spontaneous closure, availability of effective safe medical therapies, and the potential short and long-term complications of surgical ligation, the use such prophylactic surgical therapy is not indicated in the management of the preterm infants.