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1.
BMJ Open Qual ; 13(Suppl 1)2024 Apr 16.
Artículo en Inglés | MEDLINE | ID: mdl-38626941

RESUMEN

OBJECTIVE: Our aim was to refine the essential newborn care practices by employing the multidisciplinary peer team-led quality improvement (QI) projects. DESIGN: In 2017, concerning the same, the department focused on early initiation of breast feeding, prevention of hypothermia within an hour of life and rational usage of antibiotics among babies admitted to neonatal intensive care unit (NICU). Baseline data reported the rate of initiation of breast feeding, hypothermia and antibiotic exposure rate as 35%, 78% and 75%, respectively. Root causes were analysed and a series of Plan-Do-Study-Act cycles were conducted to test the changes. The process of change was studied through run charts (whereas control charts were used for study purpose). RESULT: After the implementation of the QI projects, the rate of initiation of breast feeding was found to be improved from 35% to 90%, the incidence of hypothermia got reduced from 78% to 10% and the antibiotic exposure rate declined from 75% to 20%. Along with the improvement in indicators related to essential newborn care, down the stream we found a decrease in the percentage of culture-positive sepsis rate in the NICU. CONCLUSION: Peer team-led QI initiatives in a resource-limited setting proved beneficial in improving essential newborn care practices.


Asunto(s)
Hipotermia , Mejoramiento de la Calidad , Recién Nacido , Lactante , Femenino , Humanos , Hipotermia/prevención & control , Hospitales de Enseñanza , India , Antibacterianos/uso terapéutico , Hospitales Públicos
2.
Am J Perinatol ; 2023 Oct 17.
Artículo en Inglés | MEDLINE | ID: mdl-37699520

RESUMEN

OBJECTIVE: Preterm infants have a higher rate of hypoglycemia and hyperglycemia, both of which have been associated with increased neonatal morbidities. The aim of this study was to evaluate the incidence of abnormal glucose homeostasis during the first 72 hours of life and study its association with major morbidities in infants admitted to our neonatal intensive care unit (NICU). STUDY DESIGN: This was a retrospective single-center study. We extracted demographic, maternal, and patient information and blood glucose levels for the first 72 hours of life for all infants with birth weight ≤1,000 g admitted to the NICU from January 2017 to December 2019. Continuous data were presented as mean ± standard deviation or as median with interquartile range. Categorical data were presented as frequency and percentage. Student's t-tests and Mann-Whitney U test were used to analyze continuous data and chi-squared test or Fisher's exact test were used to analyze categorical data. Logistic regression analysis was performed to study the relation between hyperglycemia and various morbidities after controlling for gestational age (GA). Statistical significance was set at p < 0.05. RESULTS: Of the 235 infants included in the study, 49% were hypoglycemic at admission to the NICU. Infants that were small for GA and those with history of maternal ß-blocker use had a higher incidence of hypoglycemia. Hypoglycemia at admission was not associated with increased mortality or any major morbidities. Seventy-three percent infants who were hypoglycemic or euglycemic at birth developed iatrogenic hyperglycemia during the first 72 hours of life. The incidence of retinopathy of prematurity (ROP) and severe ROP was higher in infants with hyperglycemia on univariate analysis. However, on multivariate analysis, after adjusting for GA, no difference was noted in the incidence of ROP between the two groups. Multivariate analysis could not be performed for severe ROP due to inadequate sample size. CONCLUSION: Hyperglycemia in the initial 3 days of life is associated with an increased incidence of severe ROP in preterm infants. Neonatologists should aim to maintain euglycemia in these infants to decrease the risk of adverse outcomes. KEY POINTS: · Preterm infants have a high rate of both hypoglycemia and hyperglycemia.. · Majority of infants who were euglycemic or hypoglycemic at birth develop iatrogenic hyperglycemia.. · Hyperglycemia in the initial 3 days of life is associated with an increased incidence of severe ROP in preterm infants..

3.
Sci Rep ; 13(1): 9509, 2023 06 12.
Artículo en Inglés | MEDLINE | ID: mdl-37308556

RESUMEN

The objective of this study is to evaluate the effectiveness of a cue-based feeding protocol in improving time to nipple feed and time to discharge in very low birth weight infants in a Level III Neonatal Intensive Care Unit. Demographic, feeding, and discharge data were recorded and compared between the two cohorts. The pre-protocol cohort included infants born from August 2013 through April 2016 and the post-protocol cohort included infants born from January 2017 through December 2019. 272 infants were included in the pre-protocol cohort and 314 infants in the post-protocol cohort. Both cohorts were statistically comparable in gestational age, gender, race, birthweight, prenatal care, antenatal steroid use, and rates of maternal diabetes. There were statistically significant differences between the pre- versus post-protocol cohorts in median post-menstrual age (PMA) in days at first nipple feed (PO) (240 vs 238, p = 0.025), PMA in days at full PO (250 vs 247, p = 0.015), and length of stay in days (55 vs 48, p = 0.0113). Comparing each year in the post-protocol cohort, for each outcome measure, a similar trend was noted in 2017 and 2018, but not in 2019. In conclusion, the cue-based feeding protocol was associated with a decrease in the time to first PO, time to full nipple feeds, and the length of stay in very-low-birthweight infants.


Asunto(s)
Señales (Psicología) , Pezones , Femenino , Humanos , Recién Nacido , Embarazo , Peso al Nacer , Recién Nacido de muy Bajo Peso , Alta del Paciente , Masculino
4.
Front Pediatr ; 10: 820259, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35356441

RESUMEN

Bronchopulmonary Dysplasia (BPD) is a multifactorial disease affecting over 35% of extremely preterm infants born each year. Despite the advances made in understanding the pathogenesis of this disease over the last five decades, BPD remains one of the major causes of morbidity and mortality in this population, and the incidence of the disease increases with decreasing gestational age. As inflammation is one of the key drivers in the pathogenesis, it has been targeted by majority of pharmacological and non-pharmacological methods to prevent BPD. Most extremely premature infants receive a myriad of medications during their stay in the neonatal intensive care unit in an effort to prevent or manage BPD, with corticosteroids, caffeine, and diuretics being the most commonly used medications. However, there is no consensus regarding their use and benefits in this population. This review summarizes the available literature regarding these medications and aims to provide neonatologists and neonatal providers with evidence-based recommendations.

5.
Hosp Pediatr ; 12(2): 173-181, 2022 02 01.
Artículo en Inglés | MEDLINE | ID: mdl-35001101

RESUMEN

BACKGROUND: We report a statewide quality improvement initiative aimed to decrease the incidence of extrauterine growth restriction among very low birth weight infants cared for in Tennessee NICUs. METHODS: The cohort consisted of infants born appropriate for gestational age between May 2016 and December 2018 from 9 NICUs across Tennessee. The infants were 23 to 32 weeks gestation and 500 to 1499 g birth weight. The process measures were the hours of life (HOL) when parenteral protein and intravenous lipid emulsion were initiated, the number of days to first enteral feeding, and attainment of full enteral caloric intake (110-130 kcal/kg per day). The primary outcome was extrauterine growth restriction, defined as weight <10th percentile for weight at 36 weeks postmenstrual age. Statistical process control charts and the Shewhart control rules were used to find special cause variation. RESULTS: Although special cause variation was not indicated in the primary outcome measure, it was indicated for the reduction in specific process measures: HOL when parenteral protein was initiated, HOL when intravenous lipid emulsion was initiated, and the number of days to attainment of full enteral caloric intake (among the hospitals considered regional perinatal centers). CONCLUSIONS: A statewide quality improvement initiative led to earlier initiation of parenteral and enteral nutrition and improved awareness of the importance of postnatal nutrition.


Asunto(s)
Recien Nacido Prematuro , Recién Nacido de muy Bajo Peso , Peso al Nacer , Femenino , Edad Gestacional , Humanos , Lactante , Recién Nacido , Nutrición Parenteral , Embarazo
6.
BMJ Open Qual ; 10(Suppl 1)2021 07.
Artículo en Inglés | MEDLINE | ID: mdl-34344740

RESUMEN

Antibiotic misuse is the most common cause of antimicrobial resistance-a globally declared emergency. This necessitates the introduction of rational antibiotic usage management policy. The paediatrics department of a public teaching hospital with around 500 neonatal intensive care unit (NICU) admissions annually revealed 75% of NICU admission exposure to any antibiotics. The aim was to institute antibiotic stewardship programme (ASP) to optimise antibiotic usage from existing 75% to 40% in a 6-month period through a quality improvement (QI) project.A root cause analysis using fishbone diagram was performed to identify the possible reasons for the high antibiotic usage. Six Plan-Do-Study-Act cycles were conducted to implement the protocols for usage of antibiotics for well-defined indications; active laboratory engagement to decrease the turnaround time for blood culture results; a hard stop to all antibiotic orders after 72 hours; streamlining of antibiotic usage; strengthening universal aseptic practices; and confidence building of staff. The outcomes monitored were antibiotic exposure rates, average number of antibiotic days in all NICU admissions, sepsis rates and mortality.Institution of ASP had significantly reduced antibiotic exposure in NICU admissions, that is, from 75% in March to 41% in August 2018. Median (IQR) antibiotic days per infant in NICU went down from 3 to 0 (0-6). The per cent of NICU admission with culture-positive sepsis and all-cause mortality rate in NICU declined from 18% to 11.56% and 25% to 16%, respectively, over these 6 months.Thus, ASP for rationalising antibiotic usage was successfully instituted in NICU of a rural medical college in central India through QI, without any adverse effect on sepsis and mortality.


Asunto(s)
Programas de Optimización del Uso de los Antimicrobianos , Unidades de Cuidado Intensivo Neonatal , Antibacterianos/uso terapéutico , Niño , Hospitales de Enseñanza , Humanos , Lactante , Recién Nacido , Mejoramiento de la Calidad
7.
Pediatr Res ; 90(2): 459-463, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33214673

RESUMEN

BACKGROUND: The aim of this study was to investigate the association between race and severe neonatal opioid withdrawal syndrome (NOWS) in infants exposed to intrauterine opioids. METHODS: This is a prospective observational study on intrauterine opioid-exposed term infants. Exposure to opioids was based on maternal disclosure, urine, or umbilical cord drug screening. Severe NOWS was defined based on modified Finnegan scoring and the need for pharmacological intervention. RESULTS: One hundred and fifty mother-infant pairs, 60 Black and 90 White with history of opioid exposure during pregnancy, were included. More White than Black infants developed NOWS that required pharmacological treatment, 70 vs. 40%: RR = 1.75 (1.25-2.45). In adjusted analysis, there was no significant association between race and the development of severe NOWS in mothers who attended opioid maintenance treatment program (OMTP). However, in mothers who did not attend OMTP, White race remained a significant factor associated with the development of severe NAS, RR = 1.69 (1.06, 2.69). CONCLUSIONS: Severe NOWS that required pharmacological intervention was significantly higher in White than in Black infants born to mothers who did not attend OMTP. Larger studies are needed to evaluate the association between social as well as genetic factors and the development of NOWS. IMPACT: There is a significant association between race and development of severe NOWS.


Asunto(s)
Analgésicos Opioides/efectos adversos , Negro o Afroamericano , Madres , Síndrome de Abstinencia Neonatal/etnología , Trastornos Relacionados con Opioides/etnología , Población Blanca , Adulto , Femenino , Humanos , Recién Nacido , Síndrome de Abstinencia Neonatal/diagnóstico , Síndrome de Abstinencia Neonatal/tratamiento farmacológico , Tratamiento de Sustitución de Opiáceos , Trastornos Relacionados con Opioides/diagnóstico , Trastornos Relacionados con Opioides/rehabilitación , Embarazo , Estudios Prospectivos , Factores Raciales , Medición de Riesgo , Factores de Riesgo , Índice de Severidad de la Enfermedad , Tennessee/epidemiología , Adulto Joven
8.
J Neonatal Perinatal Med ; 12(4): 391-397, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31356218

RESUMEN

BACKGROUND: To describe amplitude-integrated encephalogram (aEEG) characteristics of neonates with neonatal abstinence syndrome (NAS). METHODS: This is a prospective observational study. Newborns exposed to prenatal opioids and their gestational matched controls were included. A single-channel aEEG was obtained using Olympic 6000 CFM monitor. The background activity (continuous/discontinuous), the amplitudes (µV) and the presence of sleep-wake cycle (SWC) were documented. RESULTS: A total of 59 infants, 23 with NAS and 36 controls were enrolled. All aEEG were completed within 48 hours of life prior to initiation of treatment. Birth weight and gestational age were similar in both groups. An aEEG was abnormal (discontinuous pattern and/or absent SWC) in 78 % (18/23) of infants with NAS versus only 25% in control group (9/36), [OR 10.8, CI (2.7-46.5) P < 0.001]. 61% of infants with NAS had discontinuous pattern [OR 7.8, CI (2-32) P = 0.001] and 39% had absence of sleep-wake cycle [OR 7.1, CI (1.4-39.4) P = 0.007]. CONCLUSIONS: A majority of infants with NAS have abnormal aEEG activity.


Asunto(s)
Encéfalo/fisiopatología , Electroencefalografía , Síndrome de Abstinencia Neonatal/fisiopatología , Trastornos del Sueño del Ritmo Circadiano/fisiopatología , Adulto , Encéfalo/irrigación sanguínea , Encéfalo/diagnóstico por imagen , Electroencefalografía/instrumentación , Femenino , Edad Gestacional , Guías como Asunto , Humanos , Recién Nacido , Recien Nacido Prematuro , Masculino , Monitoreo Fisiológico , Síndrome de Abstinencia Neonatal/diagnóstico por imagen , Proyectos Piloto , Embarazo , Estudios Prospectivos , Trastornos del Sueño del Ritmo Circadiano/diagnóstico por imagen
9.
Infect Control Hosp Epidemiol ; 39(9): 1074-1079, 2018 09.
Artículo en Inglés | MEDLINE | ID: mdl-30019659

RESUMEN

OBJECTIVE: To describe an adenovirus outbreak in a neonatal intensive care unit (NICU), including the use of qualitative and semiquantitative real-time polymerase chain reaction (qPCR) data to inform the outbreak response. DESIGN: Mixed prospective and retrospective observational study. SETTING: A level IV NICU in the southeastern United States.PatientsTwo adenovirus cases were identified in a NICU. Screening of all inpatients with qPCR on nasopharyngeal specimens revealed 11 additional cases.InterventionsOutbreak response procedures, including enhanced infection control policies, were instituted. Serial qPCR studies were used to screen for new infections among exposed infants and to monitor viral clearance among cases. Changes to retinopathy of prematurity (ROP) exam procedures were made after an association was noted in those patients. At the end of the outbreak, a retrospective review allowed for comparison of clinical factors between the infected and uninfected groups. RESULTS: There were no new cases among patients after outbreak identification. One adenovirus-infected patient died; the others recovered their clinical baselines. The ROP exams were associated with an increased risk of infection (odds ratio [OR], 84.6; 95% confidence interval [CI], 4.5-1,601). The duration of the outbreak response was 33 days, and the previously described second wave of cases after the end of the outbreak did not occur. Revisions to infection control policies remained in effect following the outbreak. CONCLUSIONS: Retinopathy of prematurity exams are potential mechanisms of adenovirus transmission, and autoclaved or single-use instruments should be used to minimize this risk. Real-time molecular diagnostic and quantification data guided outbreak response procedures, which rapidly contained and fully terminated a NICU adenovirus outbreak.


Asunto(s)
Infecciones por Adenovirus Humanos/transmisión , Brotes de Enfermedades , Control de Infecciones/métodos , Tamizaje Neonatal/efectos adversos , Reacción en Cadena en Tiempo Real de la Polimerasa , Retinopatía de la Prematuridad/diagnóstico , Adenovirus Humanos/clasificación , Infección Hospitalaria/virología , Femenino , Humanos , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Masculino , Tamizaje Neonatal/métodos , Estudios Prospectivos , Estudios Retrospectivos , Serogrupo , Tennessee
10.
Glob Pediatr Health ; 5: 2333794X18765366, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29662925

RESUMEN

Objective. The objective of this study was to determine factors contributing to improvements in infant mortality rates (IMR) and composite morbidity-mortality in very-low-birth-weight (VLBW) infants after initiating a new perinatal program in 2009 at Regional One Health (ROH). VLBW infants account for 67% of infant deaths. Design. This is a pre-/postintervention cohort study of prospectively gathered data. Population. VLBW infants delivered at ROH during the 2004 to 2015 study period. Setting. ROH is a Regional Perinatal Center affiliated with the University of Tennessee Health Science Center. Methods. We studied 2364 consecutive VLBW infants. Multivariate models were applied to determine factors contributing significantly to the reduction in the outcome measures as well as trends over time. Main Outcome Measures. Primary outcomes were IMR and composite morbidity-mortality rates. Standardized, risk-adjusted mortality and composite morbidity ratios were also reported as defined by the Vermont Oxford Network. Results. Mortality declined from 15.5% in Pre-Implementation to 13.1% in Post-Implementation (P = .093), corresponding to an 18% reduction in odds. The combined factors of composite morbidity-mortality rate decreased from 55.7% in Pre-Implementation to 43.9% in Post-Implementation (P < .0001), representing a 38% reduction in odds. Standardized, risk-adjusted mortality and composite morbidity ratios improved during the study period from 20% above to 20% below the expected rate. Increases in the administration of antenatal steroids, surfactant administration, cesarean delivery, and perhaps other programmatic changes that were observational and unaccounted in the model were associated with improvements in outcome measures. Conclusions. Decreased mortality and composite morbidity-mortality in VLBW infants delivered at ROH were found following the initiation of a new perinatal program.

11.
J Pediatr ; 183: 19-25.e2, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-28100402

RESUMEN

OBJECTIVE: To determine the effects of late surfactant on respiratory outcomes determined at 1-year corrected age in the Trial of Late Surfactant (TOLSURF), which randomized newborns of extremely low gestational age (≤28 weeks' gestational age) ventilated at 7-14 days to late surfactant and inhaled nitric oxide vs inhaled nitric oxide-alone (control). STUDY DESIGN: Caregivers were surveyed in a double-blinded manner at 3, 6, 9, and 12 months' corrected age to collect information on respiratory resource use (infant medication use, home support, and hospitalization). Infants were classified for composite outcomes of pulmonary morbidity (no PM, determined in infants with no reported respiratory resource use) and persistent PM (determined in infants with any resource use in ≥3 surveys). RESULTS: Infants (n = 450, late surfactant n = 217, control n = 233) were 25.3 ± 1.2 weeks' gestation and 713 ± 164 g at birth. In the late surfactant group, fewer infants received home respiratory support than in the control group (35.8% vs 52.9%, relative benefit [RB] 1.28 [95% CI 1.07-1.55]). There was no benefit of late surfactant for No PM vs PM (RB 1.27; 95% CI 0.89-1.81) or no persistent PM vs persistent PM (RB 1.01; 95% CI 0.87-1.17). After adjustment for imbalances in baseline characteristics, relative benefit of late surfactant treatment increased: RB 1.40 (95% CI 0.89-1.80) for no PM and RB 1.24 (95% CI 1.08-1.42) for no persistent PM. CONCLUSION: Treatment of newborns of extremely low gestational age with late surfactant in combination with inhaled nitric oxide decreased use of home respiratory support and may decrease persistent pulmonary morbidity. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01022580.


Asunto(s)
Recien Nacido con Peso al Nacer Extremadamente Bajo , Óxido Nítrico/administración & dosificación , Surfactantes Pulmonares/administración & dosificación , Respiración Artificial/métodos , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Administración por Inhalación , Factores de Edad , Displasia Broncopulmonar/prevención & control , Intervalos de Confianza , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Esquema de Medicación , Femenino , Estudios de Seguimiento , Edad Gestacional , Humanos , Lactante , Recién Nacido , Masculino , Síndrome de Dificultad Respiratoria del Recién Nacido/diagnóstico , Medición de Riesgo , Tasa de Supervivencia , Factores de Tiempo
12.
Am J Perinatol ; 34(2): 169-173, 2017 01.
Artículo en Inglés | MEDLINE | ID: mdl-27367284

RESUMEN

Objective To study the characteristics of very low birth weight (VLBW) infants receiving glycerin suppositories (GS) and evaluate the association of GS use with outcomes. Study Design This is a retrospective study of VLBW infants admitted to a level III neonatal intensive care unit. Infants with birth weight between 500 and 1,499 g were evaluated. We evaluated the frequency of GS use and compared the characteristics and outcomes of the GS group with the no-GS group. Multivariate analyses controlling for gestational age and small for gestational age status were performed to study the effect of GS on outcomes. Results A total of 1,073 infants were included in the study. Out of those, 527 (49.1%) infants received GS. Incidence of necrotizing enterocolitis was not significantly different between the two groups, while days to reach full enteral feeds and length of hospital stay were significantly longer in the GS group. Conclusion Frequent use of GS warrants further prospective studies to evaluate its safety and efficacy in view of our study showing association with longer time to reach full enteral feeds. We speculate that GS use could be a marker for gastrointestinal dysmotility and hence the association with unfavorable clinical outcomes.


Asunto(s)
Nutrición Enteral , Enterocolitis Necrotizante/epidemiología , Glicerol/uso terapéutico , Recién Nacido de muy Bajo Peso , Tiempo de Internación , Femenino , Glicerol/administración & dosificación , Humanos , Incidencia , Lactante , Recien Nacido con Peso al Nacer Extremadamente Bajo , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Masculino , Estudios Retrospectivos , Supositorios , Factores de Tiempo
13.
Am J Perinatol ; 34(3): 270-275, 2017 02.
Artículo en Inglés | MEDLINE | ID: mdl-27490773

RESUMEN

Objectives Trisomy 18 is presumed to be a lethal chromosomal abnormality; medical management of infants with this aneuploidy is controversial. Our objective was to describe our approach and experience with trisomy 18 infants. Study Design We reviewed the initial hospital course, management, and factors predicting discharge from the hospital from two large tertiary care neonatal intensive care units in the southern United States over 26 years. Results Of the 29 infants with trisomy 18, 21 (72%) died in the hospital and 8 (28%) were discharged home. 19 (66%) infants received mechanical ventilation and 10 (34%) received inotropic medications. Eight infants had critical congenital heart defects; only one survived to discharge. Three infants underwent major surgeries; one cardiac surgery, one tracheoesophageal fistula repair, and one myelomeningocele repair. Median length of hospital stay was 14 days (range, 0-78) for all the infants and 31 days (range, 18-66) for those that were discharged home. Factors associated with discharge from the hospital were female sex, higher gestational age, and absence of critical congenital heart defects. Median survival time was 13 days and was significantly longer for females compared with males. Our 1-month and 1-year survival rates were 31% and 3.9% respectively. Conclusion A significant proportion of infants with trisomy 18 were discharged home. These data are helpful in counseling parents of infants with trisomy 18.


Asunto(s)
Peso al Nacer , Alta del Paciente , Síndrome de la Trisomía 18/terapia , Cardiotónicos/uso terapéutico , Femenino , Edad Gestacional , Cardiopatías Congénitas/etiología , Humanos , Lactante , Muerte del Lactante , Recién Nacido , Unidades de Cuidado Intensivo Neonatal , Tiempo de Internación , Nacimiento Vivo , Masculino , Muerte Perinatal , Respiración Artificial , Factores Sexuales , Tasa de Supervivencia , Centros de Atención Terciaria , Síndrome de la Trisomía 18/complicaciones , Estados Unidos
14.
Antimicrob Agents Chemother ; 60(9): 5539-45, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27401564

RESUMEN

Fluconazole is an effective agent for prophylaxis of invasive candidiasis in premature infants. The objective of this study was to characterize the population pharmacokinetics (PK) and dosing requirements of fluconazole in infants with birth weights of <750 g. As part of a randomized clinical trial, infants born at <750 g birth weight received intravenous (i.v.) or oral fluconazole at 6 mg/kg of body weight twice weekly. Fluconazole plasma concentrations from samples obtained by either scheduled or scavenged sampling were measured using a liquid chromatography-tandem mass spectrometry assay. Population PK analysis was conducted using NONMEM 7.2. Population PK parameters were allometrically scaled by body weight. Covariates were evaluated by univariable screening followed by multivariable assessment. Fluconazole exposures were simulated in premature infants using the final PK model. A population PK model was developed from 141 infants using 604 plasma samples. Plasma fluconazole PK were best described by a one-compartment model with first-order elimination. Only serum creatinine was an independent predictor for clearance in the final model. The typical population parameter estimate for oral bioavailability in the final model was 99.5%. Scavenged samples did not bias the parameter estimates and were as informative as scheduled samples. Simulations indicated that the study dose maintained fluconazole troughs of >2,000 ng/ml in 80% of simulated infants at week 1 and 59% at week 4 of treatment. Developmental changes in fluconazole clearance are best predicted by serum creatinine in this population. A twice-weekly dose of 6 mg/kg achieves appropriate levels for prevention of invasive candidiasis in extremely premature infants.


Asunto(s)
Antifúngicos/administración & dosificación , Antifúngicos/farmacocinética , Peso al Nacer/efectos de los fármacos , Fluconazol/administración & dosificación , Fluconazol/farmacocinética , Femenino , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Masculino
15.
J Pediatr ; 174: 126-131.e1, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-27112041

RESUMEN

OBJECTIVE: To compare the effect of initiating human milk fortification at 2 different feeding volumes on feeding intolerance and the time to reach full feeding volume. STUDY DESIGN: Very low birth weight infants (n = 100) were prospectively randomized to early fortification (EF) (beginning at a feeding volume of 20 mL/kg/d) or delayed fortification (at a feeding volume of 100 mL/kg/d). We employed a standardized feeding protocol and parenteral nutrition guidelines for the nutritional management of all study infants. RESULTS: The median days to reach full feeding volumes were equivalent in the 2 groups (20 vs 20, P = .45). No significant difference was observed in the total number of episodes of feeding intolerance (58 vs 57). Two cases of necrotizing enterocolitis (Bell stage ≥2) and deaths occurred in each group. Median daily protein intake (g/kg/d) was higher in EF group in week 1 (3.3 [3.2, 3.5] vs 3.1 [2.9, 3.3], P < .001), week 2 (3.6 [3.5, 3.8] vs 3.2 [2.9, 3.4], P < .001), and week 3 (3.7 [3.4, 3.9] vs 3.5 [2.8, 3.8], P = .006). Cumulative protein intake (g/kg) in the first 4 weeks of life was higher in EF group (98.6 [93.8, 104] vs 89.6 [84.2, 96.4], P < .001). CONCLUSIONS: Very early human milk fortification may improve early protein intake in very low birth weight infants without increasing frequencies of adverse events. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01988792.


Asunto(s)
Nutrición Enteral , Fórmulas Infantiles , Enfermedades del Prematuro/prevención & control , Leche Humana , Aumento de Peso , Proteínas en la Dieta , Ingestión de Energía , Femenino , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Recién Nacido de muy Bajo Peso , Masculino , Estudios Prospectivos , Factores de Tiempo
16.
J Pediatr ; 168: 23-29.e4, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26500107

RESUMEN

OBJECTIVE: To assess whether late surfactant treatment in extremely low gestational age (GA) newborn infants requiring ventilation at 7-14 days, who often have surfactant deficiency and dysfunction, safely improves survival without bronchopulmonary dysplasia (BPD). STUDY DESIGN: Extremely low GA newborn infants (GA ≤28 0/7 weeks) who required mechanical ventilation at 7-14 days were enrolled in a randomized, masked controlled trial at 25 US centers. All infants received inhaled nitric oxide and either surfactant (calfactant/Infasurf) or sham instillation every 1-3 days to a maximum of 5 doses while intubated. The primary outcome was survival at 36 weeks postmenstrual age (PMA) without BPD, as evaluated by physiological oxygen/flow reduction. RESULTS: A total of 511 infants were enrolled between January 2010 and September 2013. There were no differences between the treated and control groups in mean birth weight (701 ± 164 g), GA (25.2 ± 1.2 weeks), percentage born at GA <26 weeks (70.6%), race, sex, severity of lung disease at enrollment, or comorbidities of prematurity. Survival without BPD did not differ between the treated and control groups at 36 weeks PMA (31.3% vs 31.7%; relative benefit, 0.98; 95% CI, 0.75-1.28; P = .89) or 40 weeks PMA (58.7% vs 54.1%; relative benefit, 1.08; 95% CI, 0.92-1.27; P = .33). There were no between-group differences in serious adverse events, comorbidities of prematurity, or severity of lung disease to 36 weeks. CONCLUSION: Late treatment with up to 5 doses of surfactant in ventilated premature infants receiving inhaled nitric oxide was well tolerated, but did not improve survival without BPD at 36 or 40 weeks. Pulmonary and neurodevelopmental assessments are ongoing. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01022580.


Asunto(s)
Displasia Broncopulmonar/etiología , Óxido Nítrico/administración & dosificación , Surfactantes Pulmonares/uso terapéutico , Respiración Artificial/efectos adversos , Administración por Inhalación , Displasia Broncopulmonar/epidemiología , Femenino , Humanos , Recién Nacido , Recien Nacido Prematuro , Enfermedades del Prematuro/mortalidad , Enfermedades del Prematuro/terapia , Recién Nacido de muy Bajo Peso , Masculino , Óxido Nítrico/efectos adversos , Surfactantes Pulmonares/efectos adversos , Respiración Artificial/mortalidad , Tasa de Supervivencia , Estados Unidos
17.
Am J Perinatol ; 33(4): 370-7, 2016 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-26469991

RESUMEN

OBJECTIVE: This study aims to study the association between trends in medication utilization and survival in very low-birth-weight (VLBW) infants over a 22-year period. STUDY DESIGN: Medications received by VLBW infants were extracted retrospectively for the four periods 1990 to 1994, 1995 to 2000, 2001 to 2005, and 2006 to 2011 from our perinatal database and stratified by two birth weight groups: ≤ 1,000 g and 1,001 to 1,500 g. RESULT: A total of 5,529 VLBW infants were reviewed. The majority of them were African American (78%), with an increasing proportion over time. The median number of medications per patient in all VLBW infants remained similar over time, 9 (5, 15). A cardiovascular group of medications was most commonly used, with a significant increase in the use of dobutamine and indomethacin. A significant trend toward an increasing number of infants without any antibiotic exposure was also noted. Survival steadily and significantly increased from 83 to 87%. CONCLUSION: The trends of overall medication use remained the same in our neonatal intensive care unit (NICU) over the past 22 years. There was no association between medication utilization and survival. VLBW infants continue to receive a high number of medications in the NICU, including a variety of antibiotics.


Asunto(s)
Antibacterianos/uso terapéutico , Utilización de Medicamentos/tendencias , Mortalidad Infantil/tendencias , Recién Nacido de muy Bajo Peso , Unidades de Cuidado Intensivo Neonatal , Peso al Nacer , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Embarazo , Análisis de Regresión , Estudios Retrospectivos , Tennessee
18.
Am J Perinatol ; 32(13): 1281-6, 2015 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-26070122

RESUMEN

OBJECTIVE: This study aims to evaluate whether infants born at ≤ 32 weeks' gestational age (GA) can mount C-reactive protein (CRP) responses during early onset bacterial sepsis that are comparable to infants born at > 32 weeks' GA. METHODS: Retrospectively (2003-2012) infants with a positive bacterial culture during the first 72 hours of life were identified and grouped into two categories based on their GA: ≤ 32 weeks (group A) and > 32 weeks (group B). RESULTS: Group A included 25 and group B included 122 infants. Both groups responded similarly to sepsis with an increase in CRP (p = 0.59). Each group had a significant change in intragroup CRP levels over time (p < 0.0001). However, in both groups, the degree of this change was at the same rate over time (p = 0.74). CONCLUSION: CRP responses to bacterial sepsis during the first 72 hours of life in infants born at ≤ 32 weeks' GA are comparable to infants born at > 32 weeks' GA.


Asunto(s)
Bacteriemia/inmunología , Proteína C-Reactiva/inmunología , Enfermedades del Recién Nacido/inmunología , Recien Nacido Prematuro/inmunología , Sepsis/inmunología , Bacteriemia/microbiología , Estudios de Cohortes , Infecciones por Escherichia coli/inmunología , Femenino , Edad Gestacional , Humanos , Recién Nacido , Enfermedades del Recién Nacido/microbiología , Masculino , Estudios Retrospectivos , Sepsis/microbiología , Infecciones Estafilocócicas/inmunología , Infecciones Estreptocócicas/inmunología , Streptococcus agalactiae
19.
J Hum Lact ; 31(1): 43-6, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25326415

RESUMEN

Breast milk feeding has advantages over formula feeding in premature infants, but its use in them is low. We initiated measures in our inner-city hospital such as starting a dedicated lactation service, counseling the mothers prenatally and postnatally, educating hospital staff, and advocating with our state's Medicaid insurance to provide free home breast pumps. These measures were associated with improvement in our breast milk feeding rates in very low birth weight infants from 22% to 88% over 5 years. This article describes our multipronged approach and can help encourage and guide other units with similar demographics to improve their breast milk feeding rates.


Asunto(s)
Extracción de Leche Materna/economía , Recién Nacido de muy Bajo Peso , Servicios de Salud Materno-Infantil/normas , Extracción de Leche Materna/estadística & datos numéricos , Femenino , Hospitales Públicos , Humanos , Recién Nacido , Medicaid , Atención Posnatal/normas , Atención Prenatal/normas , Mejoramiento de la Calidad , Tennessee , Estados Unidos , Población Urbana
20.
BMC Pediatr ; 14: 121, 2014 May 09.
Artículo en Inglés | MEDLINE | ID: mdl-24886471

RESUMEN

BACKGROUND: Invasive methicillin-resistant Staphylococcus aureus (MRSA) and methicillin-sensitive Staphylococcus aureus (MSSA) infections are major causes of numerous neonatal intensive care unit (NICU) outbreaks. There have been increasing reports of MRSA outbreaks in various neonatal intensive care units (NICUs) over the last decade. Our objective was to review the experience of Staphylococcus aureus sepsis in our NICU in the last decade and describe the trends in the incidence of Staphylococcus aureus blood stream infections from 2000 to 2009. METHODS: A retrospective perinatal database review of all neonates admitted to our NICU with blood cultures positive for Staphylococcus aureus from (Jan 1st 2000 to December 31st 2009) was conducted. Infants were identified from the database and data were collected regarding their clinical characteristics and co-morbidities, including shock with sepsis and mortality. Period A represents patients admitted in 2000-2003. Period B represents patients seen in 2004-2009. RESULTS: During the study period, 156/11111 infants were identified with Staphylococcus aureus blood stream infection: 41/4486 (0.91%) infants in Period A and 115/6625 (1.73%) in Period B (p < 0.0004). Mean gestation at birth was 26 weeks for infants in both periods. There were more MRSA infections in Period B (24% vs. 55% p < 0.05) and they were associated with more severe outcomes. In comparing the cases of MRSA infections observed in the two periods, infants in period B notably had significantly more pneumonia cases (2.4% vs. 27%, p = 0.0005) and a significantly higher mortality rate (0% vs. 15.7%, p = 0.0038). The incidences of skin and soft tissue infections and of necrotizing enterocolitis were not significantly changed in the two periods. CONCLUSION: There was an increase in the incidence of Staphylococcus aureus infection among neonates after 2004. Although MSSA continues to be a problem in the NICU, MRSA infections were more prevalent in the past 6 years in our NICU. Increased severity of staphylococcal infections and associated rising mortality are possibly related to the increasing MRSA infections with a more virulent community-associated strain.


Asunto(s)
Unidades de Cuidado Intensivo Neonatal , Sepsis/microbiología , Infecciones Estafilocócicas/epidemiología , Antibacterianos/uso terapéutico , Peso al Nacer , Clindamicina/uso terapéutico , Enterocolitis Necrotizante/tratamiento farmacológico , Enterocolitis Necrotizante/epidemiología , Enterocolitis Necrotizante/microbiología , Mortalidad Hospitalaria/tendencias , Humanos , Recién Nacido , Tiempo de Internación/estadística & datos numéricos , Tiempo de Internación/tendencias , Staphylococcus aureus Resistente a Meticilina/aislamiento & purificación , Neumonía Bacteriana/tratamiento farmacológico , Neumonía Bacteriana/epidemiología , Neumonía Bacteriana/microbiología , Estudios Retrospectivos , Sepsis/epidemiología , Enfermedades Cutáneas Bacterianas/tratamiento farmacológico , Enfermedades Cutáneas Bacterianas/epidemiología , Enfermedades Cutáneas Bacterianas/microbiología , Infecciones de los Tejidos Blandos/tratamiento farmacológico , Infecciones de los Tejidos Blandos/epidemiología , Infecciones de los Tejidos Blandos/microbiología , Infecciones Estafilocócicas/tratamiento farmacológico , Staphylococcus aureus/aislamiento & purificación , Tennessee/epidemiología , Vancomicina/uso terapéutico
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