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OBJECTIVES: Neonates born with fetal inflammatory response (FIR) are at increased risk for adverse neonatal outcomes. Our objective was to determine whether FIR and its severity is associated with neurodevelopmental impairment (NDI) at 2 years of age or death among preterm infants. METHODS: A retrospective cohort study of prospectively collected data of all infants born <29 weeks gestational age (GA). FIR and its severity were diagnosed according to the Amsterdam Placental Workshop Group Consensus Statement. Neurodevelopmental outcomes among all participants were quantified according to Bayley III. RESULTS: Mothers of infants with FIR were significantly younger (P = 0.04) and had a greater prevalence of antenatal steroid use (P < 0.01), infection during pregnancy (P = 0.01), PPROM (P < 0.01), and clinical chorioamnionitis (P < 0.01). Infants with FIR had longer duration of hospitalization (P < 0.01), days on oxygen (P < 0.01), congenital pneumonia (P = 0.03), moderate/severe bronchopulmonary dysplasia (BPD; P < 0.01). Notably, infants with FIR were not at increased risk of NDI or death (primary outcome). Those with moderate to severe FIR (≥ stage 2 FIR) were at increased risk of developing motor & language impairment or death (P < 0.01). CONCLUSION: This is the first report demonstrating an association between the severity of FIR and subsequent NDI in preterm infants born. IMPACT STATEMENT: Fetal Inflammatory Response (FIR) is not associated Neurodevelopmental Impairement (NDI) or Death in preterm infants However, there is significant relationship between moderate to severe FIR and NDI at 2 years of age in preterm infants. This is the first study demonstrating the impact of progression and severity of FIR on NDI or Death in preterm infants. These observations provide additional insight into understanding the impact of intrauterine exposure to inflammation on the NDI or death in preterm infants.
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Importance: Maternal milk feeding of extremely preterm infants during the birth hospitalization has been associated with better neurodevelopmental outcomes compared with preterm formula. For infants receiving no or minimal maternal milk, it is unknown whether donor human milk conveys similar neurodevelopmental advantages vs preterm formula. Objective: To determine if nutrient-fortified, pasteurized donor human milk improves neurodevelopmental outcomes at 22 to 26 months' corrected age compared with preterm infant formula among extremely preterm infants who received minimal maternal milk. Design, Setting, and Participants: Double-blind, randomized clinical trial conducted at 15 US academic medical centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants younger than 29 weeks 0 days' gestation or with a birth weight of less than 1000 g were enrolled between September 2012 and March 2019. Intervention: Preterm formula or donor human milk feeding from randomization to 120 days of age, death, or hospital discharge. Main Outcomes and Measures: The primary outcome was the Bayley Scales of Infant and Toddler Development (BSID) cognitive score measured at 22 to 26 months' corrected age; a score of 54 (score range, 54-155; a score of ≥85 indicates no neurodevelopmental delay) was assigned to infants who died between randomization and 22 to 26 months' corrected age. The 24 secondary outcomes included BSID language and motor scores, in-hospital growth, necrotizing enterocolitis, and death. Results: Of 1965 eligible infants, 483 were randomized (239 in the donor milk group and 244 in the preterm formula group); the median gestational age was 26 weeks (IQR, 25-27 weeks), the median birth weight was 840 g (IQR, 676-986 g), and 52% were female. The birthing parent's race was self-reported as Black for 52% (247/478), White for 43% (206/478), and other for 5% (25/478). There were 54 infants who died prior to follow-up; 88% (376/429) of survivors were assessed at 22 to 26 months' corrected age. The adjusted mean BSID cognitive score was 80.7 (SD, 17.4) for the donor milk group vs 81.1 (SD, 16.7) for the preterm formula group (adjusted mean difference, -0.77 [95% CI, -3.93 to 2.39], which was not significant); the adjusted mean BSID language and motor scores also did not differ. Mortality (death prior to follow-up) was 13% (29/231) in the donor milk group vs 11% (25/233) in the preterm formula group (adjusted risk difference, -1% [95% CI, -4% to 2%]). Necrotizing enterocolitis occurred in 4.2% of infants (10/239) in the donor milk group vs 9.0% of infants (22/244) in the preterm formula group (adjusted risk difference, -5% [95% CI, -9% to -2%]). Weight gain was slower in the donor milk group (22.3 g/kg/d [95% CI, 21.3 to 23.3 g/kg/d]) compared with the preterm formula group (24.6 g/kg/d [95% CI, 23.6 to 25.6 g/kg/d]). Conclusions and Relevance: Among extremely preterm neonates fed minimal maternal milk, neurodevelopmental outcomes at 22 to 26 months' corrected age did not differ between infants fed donor milk or preterm formula. Trial Registration: ClinicalTrials.gov Identifier: NCT01534481.
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Enterocolite Necrosante , Leite Humano , Criança , Lactente , Recém-Nascido , Feminino , Humanos , Masculino , Lactente Extremamente Prematuro , Fórmulas Infantis , Peso ao Nascer , Método Duplo-Cego , Enterocolite Necrosante/epidemiologia , Unidades de Terapia Intensiva NeonatalRESUMO
OBJECTIVE: To evaluate changes in prevalence and severity of cerebral palsy (CP) among surviving children born at <27 weeks of gestation over time and to determine associations between CP and other developmental domains, functional impairment, medical morbidities, and resource use among 2-year-old children who were born extremely preterm. STUDY DESIGN: Retrospective cohort study using prospective registry data, conducted at 25 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Participants were children born at <27 weeks of gestation and followed at 18 through 26 months of corrected age from 2008 through 2019. Outcomes of interest were changes in prevalence of any CP and severity of CP over time and associations between CP and other neurodevelopmental outcomes, functional impairment, and medical comorbidities. Adjusted logistic, linear, multinomial logistic, and robust Poisson regression evaluated the relationships between child characteristics, CP severity, and outcomes. RESULTS: Among 6927 surviving children with complete follow-up data, 3717 (53.7%) had normal neurologic examinations, 1303 (18.8%) had CP, and the remainder had abnormal neurologic examinations not classified as CP. Adjusted rates of any CP increased each year of the study period (aOR 1.11 per year, 95% CI 1.08-1.14). Cognitive development was significantly associated with severity of CP. Children with CP were more likely to have multiple medical comorbidities, neurosensory problems, and poor growth at follow-up. CONCLUSIONS: The rate of CP among surviving children who were born extremely preterm increased from 2008 through 2019. At 18 to 26 months of corrected age, neurodevelopmental and medical comorbidities are strongly associated with all severity levels of CP.
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Paralisia Cerebral , Humanos , Paralisia Cerebral/epidemiologia , Feminino , Pré-Escolar , Prevalência , Masculino , Estudos Retrospectivos , Recém-Nascido , Lactente Extremamente Prematuro , Idade Gestacional , Índice de Gravidade de Doença , Estados Unidos/epidemiologia , Lactente , Estudos de Coortes , Sistema de RegistrosRESUMO
Maternal, placental, and neonatal factors were compared between infants born at ≤29 weeks of gestational age with admission hyperthermia (>37.5âC) and euthermia (36.5-37.5âC). Admission hyperthermia was associated with longer duration of face-mask positive-pressure ventilation and infant's temperature ≥37.5âC in the delivery room. Infants born preterm with admission hyperthermia had greater odds of developing necrotizing enterocolitis and neurodevelopmental impairment.
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Enterocolite Necrosante , Hipertermia Induzida , Lactente , Recém-Nascido , Humanos , Gravidez , Feminino , Recém-Nascido Prematuro , Placenta , Idade Gestacional , Fatores de RiscoRESUMO
OBJECTIVE: The primary objectives were to compare body mass index (BMI) Z-score (Z), systolic blood pressure (SBP), serum leptin:adiponectin (L:A) ratio and estimated glomerular filtration rate (eGFR) at ~3 years adjusted age between two arms of a randomized controlled trial (RCT) comparing two modes of human milk fortification for very low-birthweight infants in the neonatal intensive care unit. STUDY DESIGN: Follow-up of RCT at 33-48 months. RESULTS: Follow-up data are available in 82/120 infants. Infants in the experimental arm have anthropometric data consistent with central obesity and higher serum L:A ratio (sensitivity analysis adjusting for sex and using all available data), but have similar eGFR and SBP at follow-up compared with controls. Serum L:A ratio is strongly correlated with anthropometric measurements suggesting central obesity. CONCLUSIONS: Infants in the experimental arm have central obesity and higher serum L:A ratio compared with controls. Notably, serum L:A ratio is strongly correlated with weight gain. TRIAL REGISTRATION: This randomized controlled trial was registered at ClinicalTrials.gov NCT02372136.
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Adipocinas , Obesidade Abdominal , Recém-Nascido , Lactente , Humanos , Pressão Sanguínea , Seguimentos , Recém-Nascido de muito Baixo Peso , Leite Humano , Obesidade , RimRESUMO
OBJECTIVE: Extremely preterm (EP) impairment rates are likely underestimated using the Bayley III norm-based thresholds scores and may be better assessed relative to concurrent healthy term reference (TR) infants born in the same hospital. STUDY DESIGN: Blinded, certified examiners in the Neonatal Research Network (NRN) evaluated EP survivors and a sample of healthy TR infants recruited near the 2-year assessment age. RESULTS: We assessed 1452 EP infants and 183 TR infants. TR-based thresholds showed higher overall EP impairment than Bayley norm-based thresholds (O.R. = 1.86; [95% CI 1.56-2.23], especially for severe impairment (36% vs. 24%; p ≤ 0.001). Difficulty recruiting TR patients at 2 years extended the study by 14 months and affected their demographics. CONCLUSION: Impairment rates among EP infants appear to be substantially underestimated from Bayley III norms. These rates may be best assessed by comparison with healthy term infants followed with minimal attrition from birth in the same centers. GOV ID: Term Reference (under the Generic Database Study): NCT00063063.
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Desenvolvimento Infantil , Lactente Extremamente Prematuro , Humanos , Lactente , Recém-Nascido , Bases de Dados FactuaisRESUMO
OBJECTIVE: A ventricle-to-brain index (VBI) >0.35 is associated with low scores on the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) in preterm infants with birth weight <1,250 g. However, VBI obtained at the third ventricle has only moderate interobserver reliability. The objective of this study was to test (1) reliability of VBI measured at the foramen of Monro on the latest ultrasonogram (US) before discharge using the intraclass correlation coefficient (ICC) and (2) the relationship between VBI and BSID-III scores at ≥18 months corrected age. STUDY DESIGN: The present study is a single-center retrospective cohort study. RESULTS: The study included 270 preterm infants born at 230/7 to 286/7 weeks of gestational age. The ICC of VBI between independent measurements by two study radiologists on the first 50 patients was 0.934. Factors associated with the value of VBI included severe intraventricular hemorrhage, bronchopulmonary dysplasia, and systemic steroid administration for BPD but not postmenstrual age. In multivariate analysis, VBI was negatively and independently associated with cognitive (p = 0.002), language (p = 0.004), and motor (p < 0.001) BSID-III scores. The association between VBI and BSID-III scores was observed even in infants in whom the latest US was obtained before term equivalent age. The association between VBI and BSID-III scores was also observed after excluding those with severe intraventricular hemorrhage. CONCLUSION: In this very preterm cohort the measurement of VBI had excellent reliability. Moreover, VBI measurements were negatively associated with motor, language, and cognitive BSID-III scores. KEY POINTS: · Mean values of VBI are stable with postmenstrual age.. · Values at the foramen of Monro are reliable and reproducible.. · VBI is negatively associated with Bayley scores.. · The association is observed even before term age..
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BACKGROUND: Donor breast milk (DBM) feeding has been associated with less growth than formula in preterm infants. Zinc content in DBM is insufficient to support growth in preterm infants. OBJECTIVE: To compare growth from birth to discharge, macro- and micronutrient intake and the frequency of poor growth before (Epoch-1) and after (Epoch-2) implementing a DBM program. METHODS: Retrospective cohort study of 1069 infants born at < 33 weeks' gestational age or birthweight < 1500 g and fed using our adjustable feeding protocol with accurate serial length measurements. Growth was assessed by changes in Z-scores of weight, length and fronto-occipital circumference from birth to discharge. RESULTS: Growth did not decrease significantly in Epoch-2. However, energy and protein intake increased by 5% and frequency of zinc and vitamin D supplementation increased by >30%. CONCLUSIONS: DBM implementation did not significantly decrease growth from birth to discharge using our adjustable feeding protocol.
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Recém-Nascido Prematuro , Leite Humano , Lactente , Feminino , Recém-Nascido , Humanos , Peso ao Nascer , Idade Gestacional , Estudos Retrospectivos , Fórmulas Infantis , Recém-Nascido de muito Baixo PesoRESUMO
BACKGROUND: Human milk supplementation for preterm infants in the neonatal intensive care unit (NICU) can be based on optimized nutrition (feeding adjustments based on growth and measurements of serum nutrients) or individualized nutrition (measurements of macronutrients in mother's own milk). OBJECTIVE: To compare Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) at 18-38mo adjusted age in infants who had been randomly allocated to individualized+optimized nutrition (experimental group) vs optimized nutrition alone (control) in the NICU. METHODS: Double-blinded randomized controlled trial in neonates <29wks gestational age (GA) and those <34wks GA and small for GA. RESULTS: Bayley scores were assessed in 91/114 (80%) infants. The two study groups had similar frequencies of low cognitive, motor and language Bayley scores and similar age-adjusted Bayley scores in bivariate and multivariate analyses. CONCLUSIONS: The type of human milk supplementation provided had no significant effect on Bayley scores assessed at 18-38mo. TRIAL REGISTRATION: This randomized controlled trial was registered at ClinicalTrials.gov NCT02372136.
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Recém-Nascido Prematuro , Recém-Nascido de muito Baixo Peso , Lactente , Recém-Nascido , Humanos , Adulto , Idade Gestacional , Leite Humano , Unidades de Terapia Intensiva Neonatal , Desenvolvimento InfantilRESUMO
BACKGROUND: Infants born very preterm (≤32 weeks gestational age, GA) and very-low birth weight (≤1500 g; PT-VLBW) demonstrate high systolic blood pressure (SBP), renal dysfunction, and obesity at 6 months-3 years and in early adulthood. Their parallel measurement and progression during childhood is unclear. METHODS: We reenrolled 62/120 patients originally seen at 1-3 years at 10-13 years and remeasured anthropometric indices, SBP, and serum creatinine (Cr) and cystatin C (cysC) to determine estimated glomerular filtration rate (eGFR). We selected Term-matched Controls at 10-13 years from the 2015-2016 NHANES database at a ratio of 2 Controls:1 Case (124:62). RESULTS: Reenrolled patients were predominantly Hispanic, birth weight 1073 ± 251 g, and GA at birth 28 ± 2 weeks. At 10-13 years, 45% were classified overweight/obese, 48% had SBP ≥ 90th centile (77% considered hypertensive), and 34% had low eGFR (<90 mL min-1 [1.73 m2]-1). Notably, 57% of reenrolled PT-VLBW Cases had low eGFRcysC at both 1-3 and 10-13 years, P < 0.03. Compared to Controls, Cases had four times the adjusted odds for having an elevated SBP and low eGFRCr despite similar proportions with overweight/obesity among Cases and Controls. CONCLUSIONS: PT-VLBW infants seen at 1-3 years exhibit obesity, elevated SBP, and low eGFR in infancy and 10-13 years. Although the small sample size may limit conclusions, pediatricians should consider serial evaluations of PT-VLBW throughout childhood. IMPACT: The association between preterm birth and elevated blood pressure, renal dysfunction, and obesity in young adults begins as early as 1 year and persists at 10-13 years of age. This is the first study reporting serial measurements of blood pressure, renal function, and obesity from infancy to preadolescence in children born very preterm. Fifty-seven percent of preterm 1-3 year olds have persistent low estimated glomerular filtration rate associated with hypertension at 10-13 years. Clinicians should consider serial evaluations of blood pressure, renal function, and obesity throughout infancy and childhood in all preterm births.
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Hipertensão , Nefropatias , Nascimento Prematuro , Lactente , Criança , Feminino , Humanos , Recém-Nascido , Pré-Escolar , Adulto , Recém-Nascido Prematuro , Sobrepeso , Rim , Inquéritos Nutricionais , Pressão Sanguínea/fisiologia , Obesidade , Taxa de Filtração GlomerularRESUMO
BACKGROUND: Bronchopulmonary dysplasia is a prevalent complication after extremely preterm birth. Inflammation with mechanical ventilation may contribute to its development. Whether hydrocortisone treatment after the second postnatal week can improve survival without bronchopulmonary dysplasia and without adverse neurodevelopmental effects is unknown. METHODS: We conducted a trial involving infants who had a gestational age of less than 30 weeks and who had been intubated for at least 7 days at 14 to 28 days. Infants were randomly assigned to receive either hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days) or placebo. Mandatory extubation thresholds were specified. The primary efficacy outcome was survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age, and the primary safety outcome was survival without moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age. RESULTS: We enrolled 800 infants (mean [±SD] birth weight, 715±167 g; mean gestational age, 24.9±1.5 weeks). Survival without moderate or severe bronchopulmonary dysplasia at 36 weeks occurred in 66 of 398 infants (16.6%) in the hydrocortisone group and in 53 of 402 (13.2%) in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Hypertension that was treated with medication occurred more frequently with hydrocortisone than with placebo (4.3% vs. 1.0%). Other adverse events were similar in the two groups. CONCLUSIONS: In this trial involving preterm infants, hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01353313.).
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Displasia Broncopulmonar/prevenção & controle , Glucocorticoides/uso terapêutico , Hidrocortisona/uso terapêutico , Recém-Nascido Prematuro , Extubação , Displasia Broncopulmonar/epidemiologia , Método Duplo-Cego , Seguimentos , Glucocorticoides/administração & dosagem , Glucocorticoides/efeitos adversos , Humanos , Hidrocortisona/administração & dosagem , Hidrocortisona/efeitos adversos , Lactente Extremamente Prematuro , Recém-Nascido , Transtornos do Neurodesenvolvimento/epidemiologia , Transtornos do Neurodesenvolvimento/prevenção & controle , Oxigenoterapia , Respiração ArtificialRESUMO
OBJECTIVE: Determine whether blanket temperatures during therapeutic hypothermia (TH) are associated with 18-22 month outcomes for infants with hypoxic ischemic encephalopathy (HIE). STUDY DESIGN: Retrospective cohort study of 181 infants with HIE who received TH in two randomized trials within the Neonatal Research Network. We defined summative blanket temperature constructs and evaluated for association with a primary composite outcome of death or moderate/ severe disability at 18-22 months. RESULTS: Each 0.5 °C above 33.5 °C in the mean of the highest quartile blanket temperature was associated with a 52% increase in the adjusted odds of death/ disability (aOR 1.52, 95% CI 1.09-2.11). Having >8 consecutive blanket temperatures above 33.5 °C rendered an aOR of death/disability of 5.04 in the first 24 h (95% CI 1.54-16.6) and 6.92 in the first 48 h (95% CI 2.20-21.8) of TH. CONCLUSIONS: Higher blanket temperature during TH may be an early, clinically useful biomarker of HIE outcome.
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Hipotermia Induzida , Hipóxia-Isquemia Encefálica , Febre , Humanos , Hipóxia-Isquemia Encefálica/complicações , Hipóxia-Isquemia Encefálica/terapia , Lactente , Recém-Nascido , Estudos Retrospectivos , TemperaturaRESUMO
Importance: Compared with normothermia, hypothermia has been shown to reduce death or disability in neonatal hypoxic ischemic encephalopathy but data on seizures during rewarming and associated outcomes are scarce. Objective: To determine whether electrographic seizures are more likely to occur during rewarming compared with the preceding period and whether they are associated with abnormal outcomes in asphyxiated neonates receiving hypothermia therapy. Design, Setting, and Participants: This prespecified nested cohort study of infants enrolled in the Optimizing Cooling (OC) multicenter Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network trial from December 2011 to December 2013 with 2 years' follow-up randomized infants to either 72 hours of cooling (group A) or 120 hours (group B). The main trial included 364 infants. Of these, 194 were screened, 10 declined consent, and 120 met all predefined inclusion criteria. A total of 112 (90%) had complete data for death or disability. Data were analyzed from January 2018 to January 2020. Interventions: Serial amplitude electroencephalography recordings were compared in the 12 hours prior and 12 hours during rewarming for evidence of electrographic seizure activity by 2 central amplitude-integrated electroencephalography readers blinded to treatment arm and rewarming epoch. Odds ratios and 95% CIs were evaluated following adjustment for center, prior seizures, depth of cooling, and encephalopathy severity. Main Outcomes and Measures: The primary outcome was the occurrence of electrographic seizures during rewarming initiated at 72 or 120 hours compared with the preceding 12-hour epoch. Secondary outcomes included death or moderate or severe disability at age 18 to 22 months. The hypothesis was that seizures during rewarming were associated with higher odds of abnormal neurodevelopmental outcomes. Results: A total of 120 newborns (70 male [58%]) were enrolled (66 in group A and 54 in group B). The mean (SD) gestational age was 39 (1) weeks. There was excellent interrater agreement (κ, 0.99) in detection of seizures. More infants had electrographic seizures during the rewarming epoch compared with the preceding epoch (group A, 27% vs 14%; P = .001; group B, 21% vs 10%; P = .03). Adjusted odd ratios (95% CIs) for seizure frequency during rewarming were 2.7 (1.0-7.5) for group A and 3.2 (0.9-11.6) for group B. The composite death or moderate to severe disability outcome at 2 years was significantly higher in infants with electrographic seizures during rewarming (relative risk [95% CI], 1.7 [1.25-2.37]) after adjusting for baseline clinical encephalopathy and seizures as well as center. Conclusions and Relevance: Findings that higher odds of electrographic seizures during rewarming are associated with death or disability at 2 years highlight the necessity of electroencephalography monitoring during rewarming in infants at risk. Trial Registration: ClinicalTrials.gov Identifier: NCT01192776.
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Hipotermia Induzida , Hipóxia-Isquemia Encefálica/complicações , Hipóxia-Isquemia Encefálica/terapia , Reaquecimento , Convulsões/etiologia , Asfixia Neonatal/complicações , Estudos de Casos e Controles , Eletroencefalografia , Feminino , Humanos , Recém-Nascido , MasculinoRESUMO
OBJECTIVE: To assess if the adjusted odds of low composite cognitive Bayley-III scores changed after implementing a single-institution quality improvement (QI) project designed to decrease discharge Z-scores for weight, body mass index (BMI), and weight-for-length, but not length or fronto-occipital circumference (FOC) in infants 23-28 weeks gestational age (GA). METHODS: Compare Bayley-III outcomes at ≥18 months corrected age (postnatal age adjusted for prematurity) in infants tested before (Epoch-1) and after (Epoch-2) QI implementation. RESULTS: Bayley testing was available in 134/156 infants (86%) in Epoch-1 and 139/175 (79%) in Epoch-2. There was no change in frequency of low (<85) cognitive score (p = 0.5) or in median cognitive scores (80 in Epoch-1 vs. 85 Epoch-2, p = 0.35). The adjusted odds of low cognitive scores was not different between Epochs. CONCLUSION: No change in cognitive outcome at ≥18 months corrected age was observed after implementing a QI project designed to reduce discharge weight-for-length disproportion in very preterm infants.
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Recém-Nascido Prematuro , Melhoria de Qualidade , Pré-Escolar , Cognição , Idade Gestacional , Humanos , Lactente , Recém-Nascido , Recém-Nascido de muito Baixo PesoRESUMO
OBJECTIVE: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial. STUDY DESIGN: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. RESULTS: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40). CONCLUSIONS: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.
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Paralisia Cerebral , Lactente Extremamente Prematuro , Desenvolvimento Infantil , Idade Gestacional , Humanos , Recém-Nascido , Inositol/uso terapêuticoRESUMO
BACKGROUND: Antibiotic exposure in term infants has been associated with later obesity. Premature, very-low-birth-weight (birth weight ≤ 1500 g) infants in the neonatal intensive care unit frequently are exposed to antibiotics. Our hypothesis was that in preterm infants, there is a positive linear and dose-dependent relationship between antibiotic exposure and growth from birth through 12 months' corrected age. METHODS: Retrospective analysis of prospectively collected data of all antibiotic use among inborn, preterm (≤32 weeks' gestation), very-low-birth-weight infants admitted to the neonatal intensive care unit at Parkland Memorial Hospital and followed in the Low Birth Weight Clinic at Children's Medical Center, Dallas, TX. Antibiotic use was quantified by days of therapy which was compared with weight and length parameters at birth, 36 weeks' postmenstrual age, and 2, 4, 6, and 12 months' corrected age. The change in weight and length z-scores from birth to all subsequent age points was calculated. Stepwise multivariate regression analysis was performed to determine predictors of weight, length, and weight-for-length delta z-scores from birth to each subsequent age point. RESULTS: During the 18-month study, 161 infants received a median of 11 (IQR, 5.5-19.5) antibiotic days of therapy which was not associated with weight or length delta z-scores from birth through 12 months' corrected age. CONCLUSION: Association of prolonged antibiotic use and neonatal morbidities and mortality may override the potential association with increased weight gain in the NICU and beyond.
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Vulnerable Child Syndrome (VCS) occurs in the setting in which a child recovers from a life-threatening illness, as result of which the parent develops heightened parental perceptions of child vulnerability (PPCV). This leads to a pattern of overprotective parenting which may result in adverse neurodevelopmental and behavioral outcomes in the child over time. Parents of premature infants have been shown to be at increased risk of developing raised PPCV while their infants may develop symptoms of VCS. The PreVNT trial is a randomized controlled trial designed to test the efficacy of a 5-session manualized Cognitive Behavioral Therapy (CBT) intervention to reduce PPCV. Results of a pilot study of parents of premature infants (n = 41) demonstrate that the intervention can be delivered with high ratings of treatment fidelity and with a completion rate of 100% during the NICU admission, and 78% at 6 months post term. Ratings of parental satisfaction ranged between 4.9 and 5 out of 5 demonstrating high satisfaction with the intervention. Pilot feasibility and maternal satisfaction data are presented for a group of 22 intervention families, which suggest a CBT model for understanding VCS is feasible and deemed helpful by parents. This review is gauged to summarize risk of VCS development, diagnosis of VCS, and effective treatments for VCS through Cognitive Behavioral Therapy. We also present a paradigm shift in a therapeutic approach by introducing the PreVNT Trial. Given that VCS can interfere with the long-term outcomes of both infant and family, it is important to understand VCS and address its involvement in NICU and post NICU discharge care. Further research is needed in this area.
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Unidades de Terapia Intensiva Neonatal , Satisfação Pessoal , Anormalidades Múltiplas , Criança , Estudos de Viabilidade , Doenças Genéticas Ligadas ao Cromossomo X , Humanos , Eritrodermia Ictiosiforme Congênita , Lactente , Recém-Nascido , Deformidades Congênitas dos Membros , Pais , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
OBJECTIVE: To determine the association of persistent pulmonary hypertension of the newborn (PPHN) with death or disability among infants with moderate or severe hypoxic ischemic encephalopathy (HIE) treated with therapeutic hypothermia. METHODS: We compared infants with and without PPHN enrolled in the hypothermia arm from three randomized controlled trials (RCTs): Induced Hypothermia trial, "usual care" arm of Optimizing Cooling trial, and Late Hypothermia trial. Primary outcome was death or disability at 18-22 months adjusted for severity of HIE, center, and RCT. RESULTS: Among 280 infants, 67 (24%) were diagnosed with PPHN. Among infants with and without PPHN, death or disability was 47% vs. 29% (adjusted OR: 1.65, 0.86-3.14) and death was 26% vs. 12% (adjusted OR: 2.04, 0.92-4.53), respectively. CONCLUSIONS: PPHN in infants with moderate or severe HIE was not associated with a statistically significant increase in primary outcome. These results should be interpreted with caution given the limited sample size.
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Hipertensão Pulmonar , Hipotermia Induzida , Hipóxia-Isquemia Encefálica , Síndrome da Persistência do Padrão de Circulação Fetal , Humanos , Hipertensão Pulmonar/etiologia , Hipertensão Pulmonar/terapia , Hipóxia-Isquemia Encefálica/terapia , Lactente , Recém-Nascido , National Institute of Child Health and Human Development (U.S.) , Síndrome da Persistência do Padrão de Circulação Fetal/complicações , Síndrome da Persistência do Padrão de Circulação Fetal/terapia , Estados UnidosRESUMO
High-risk infants hospitalized in the Neonatal Intensive Care Unit (NICU) often receive life-saving interventions during a critical period of development, when their brain is highly sensitive to both positive and negative environmental factors. It is no surprise that this time is particularly challenging for families. In fact, parents of hospitalized newborns are likely to experience clinically-significant symptoms of stress, anxiety, and depression. These symptoms have the potential to impact the nature and quality of the early parent-infant relationship and can lead to long-term problematic consequences for the infant and the family. As such, perinatal parent mental health represents a key factor that impacts outcomes of high-risk children. We discuss future practices to optimize the wellbeing of NICU infants and their families in the long-term, including increasing awareness and screening for parent mental health in the NICU, as well as building systems for support and early intervention.