RESUMO
OBJECTIVE: To examine the effects of early echocardiography-targeted ibuprofen treatment of large patent ductus arteriosus (PDA) on survival without cerebral palsy at 24 months of corrected age. STUDY DESIGN: We enrolled infants born at <28 weeks of gestation with a large PDA on echocardiography at 6-12 hours after birth to ibuprofen or placebo by 12 hours of age in a multicenter, double blind, randomized-controlled trial. Open-label ibuprofen was allowed for prespecified criteria of a hemodynamically significant PDA. The primary outcome was survival without cerebral palsy at 24 months of corrected age. RESULTS: Among 337 enrolled infants, 109 had a small or closed ductus and constituted a reference group; 228 had a large PDA and were randomized. The primary outcome was assessed at 2 years in 108 of 114 (94.7%) and 102 of 114 (89.5%) patients allocated to ibuprofen or placebo, respectively. Survival without cerebral palsy occurred in 77 of 108 (71.3%) after ibuprofen, 73 of 102 (71.6%) after placebo (adjusted relative risk 0.98, 95% CI 0.83-1.16, P = .83), and 77 of 101 (76.2%) in reference group. Infants treated with ibuprofen had a lower incidence of PDA at day 3. Severe pulmonary hemorrhage during the first 3 days occurred in 2 of 114 (1.8%) infants treated with ibuprofen and 9 of 114 (7.9%) infants treated with placebo (adjusted relative risk 0.22, 95% CI 0.05-1.00, P = .05). Open-label rescue treatment with ibuprofen occurred in 62.3% of infants treated with placebo and 17.5% of infants treated with ibuprofen (P < .001), at a median (IQR) age of 4 (3, 5) and 4 (4, 12) days, respectively. CONCLUSIONS: Early echocardiography-targeted ibuprofen treatment of a large PDA did not change the rate of survival without cerebral palsy. TRIAL REGISTRATION: Eudract 2011-003063-30 and ClinicalTrials.gov: NCT01630278.
Assuntos
Paralisia Cerebral/epidemiologia , Inibidores de Ciclo-Oxigenase/uso terapêutico , Permeabilidade do Canal Arterial/tratamento farmacológico , Ibuprofeno/uso terapêutico , Lactente Extremamente Prematuro , Pré-Escolar , Método Duplo-Cego , Permeabilidade do Canal Arterial/mortalidade , Humanos , Lactente , Recém-NascidoRESUMO
OBJECTIVE: To assess the Global School Adaptation (GSA) questionnaire of children's abilities and classroom behavior administered to teachers of very preterm children at 5 years of age as a predictor of the need for educational support (grade retention, special class, learning support) at age 7. STUDY DESIGN: We assessed 858 very preterm children (<33 weeks of gestation) at 5 years of age using the GSA and again at 7 years to determine the use of educational support. We examined the association between the GSA score and educational support at 7 years and performed a receiver operating characteristic curve analysis. RESULTS: At 7 years of age, 130 children had educational support (15.2%). Children with a nonoptimal GSA score (<45) at 5 years required educational support more often (57.7%) than children with a GSA score of 45 or greater (15.4%) (OR, 7.5; 95% CI, 5.02-11.21). The need for educational support was associated with male sex; a low parent socioeconomic level; lower birth weight, birth head circumference, or gestational age (28-30 weeks of gestation); severe neurologic complications; patent ductus arteriosus ligation; and the use of therapy services at 5 years of age. After adjustment, only the GSA score was associated with educational support at 7 years of age (OR, 0.86; 95% CI, 0.84-0.88). A receiver operating characteristic curve analysis of the GSA performance revealed an optimal cut-off at 48, with a sensitivity of 70.8%, a specificity of 73.5%, and an area under the curve of 0.79. CONCLUSIONS: Using a cut-off score of 48, the GSA at 5 years of age may be a useful tool to identify children born preterm at risk of school-based learning difficulties.
Assuntos
Adaptação Psicológica/fisiologia , Deficiências da Aprendizagem/diagnóstico , Deficiências da Aprendizagem/etiologia , Avaliação das Necessidades , Fatores Etários , Criança , Pré-Escolar , Feminino , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Valor Preditivo dos Testes , Curva ROC , Inquéritos e QuestionáriosRESUMO
OBJECTIVES: To investigate the relation between neonatal intensive care unit (NICU) volume and survival, and neuromotor and sensory disabilities at 2 years in very preterm infants. STUDY DESIGN: The EPIPAGE-2 (Etude Epidémiologique sur les Petits Âges Gestationnels-2) national prospective population-based cohort study was used to include 2447 babies born alive in 66 level III hospitals between 24 and 30 completed weeks of gestation in 2011. The outcome was survival without disabilities (levels 2-5 of the Gross Motor Function Classification System for cerebral palsy with or without unilateral or bilateral blindness or deafness). Units were grouped in quartiles according to volume, defined as the annual admissions of very preterm babies. Multivariate logistic regression analyses with population average models were used. RESULTS: Survival at discharge was lower in hospitals with lower volumes of neonatal activity (aOR 0.55, 95% CI 0.33-0.91). Survival without neuromotor and sensory disabilities at 2 years increased with hospital volume, from 75% to 80.7% in the highest volume units. After adjustment for gestational age, small for gestational age, sex, maternal age, infertility treatment, multiple pregnancy, principal cause of prematurity, parental socioeconomic status, and mother's country of birth, survival without neuromotor or sensory disabilities was significantly lower in hospitals with a lower volume of neonatal activity (aOR 0.60, 95% CI 0.38-0.95) than in the highest quartile hospitals. CONCLUSIONS: These results suggest that lower neonatal intensive care unit volume is associated with lower survival without an increase in disabilities at 2 years. These results could be useful to generate improvements of perinatal regionalization.
Assuntos
Doenças do Prematuro/mortalidade , Doenças do Prematuro/terapia , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Estudos de Coortes , Utilização de Instalações e Serviços , Feminino , França , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Taxa de SobrevidaRESUMO
Preterm infants have a deficit of fat-free mass accretion during hospitalization. This study suggests that z score of fat-free mass at discharge is associated with neurologic outcome (P = .003) at 2 years of age, independent of sex, gestational age, and birth weight z score. Interventions to promote quality of growth should be considered.
Assuntos
Composição Corporal , Doenças do Prematuro/etiologia , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Transtornos do Neurodesenvolvimento/etiologia , Desenvolvimento Infantil , Pré-Escolar , Feminino , Humanos , Lactente , Fenômenos Fisiológicos da Nutrição do Lactente , Recém-Nascido , Doenças do Prematuro/epidemiologia , Unidades de Terapia Intensiva Neonatal , Masculino , Transtornos do Neurodesenvolvimento/epidemiologia , Alta do Paciente , Pletismografia , Estudos ProspectivosRESUMO
OBJECTIVE: To determine whether extrauterine growth is associated with neurologic outcomes and if this association varies by prenatal growth profile. STUDY DESIGN: For 1493 preterms from the EPIPAGE (Étude Épidémiologique sur les Petits Âges Gestationnels [Epidemiological Study on Small Gestational Ages]) cohort, appropriate for gestational-age (AGA) was defined by birth weight >-2 SD and small for gestational-age (SGA) by birth weight ≤-2 SD. Extra-uterine growth was defined by weight gain or loss between birth and 6 months by z-score change. Growth following-the-curve (FTC) was defined as weight change -1 to +1 SD, catch-down-growth (CD) as weight loss ≥1 SD, and catch-up-growth (CU) as weight gain ≥1 SD. At 5 years, a complete medical examination (n = 1305) and cognitive evaluation with the Kauffman Assessment Battery for Children (n = 1130) were performed. Behavioral difficulties at 5 years and school performance at 8 years were assessed (n = 1095). RESULTS: Overall, 42.5% of preterms were AGA-FTC, 20.2% AGA-CD, 17.1% AGA-CU, 5.6% SGA-FTC, and 14.5% SGA-CU. Outcomes did not differ between CU and FTC preterm AGA infants. Risk of cerebral palsy was greater for AGA-CD compared with AGA-FTC (aOR 2.26 [95% CI 1.37-3.72]). As compared with children with SGA-CU, SGA-FTC children showed no significant increased risk of cognitive deficiency (aOR 1.41[0.94-2.12]) or school difficulties (aOR 1.60 [0.84-3.03]). Compared with AGA-FTC, SGA showed increased risk of cognitive deficiency (SGA-FTC aOR 2.19 [1.25-3.84]) and inattention-hyperactivity (SGA-CU aOR 1.65 [1.05-2.60]). CONCLUSION: Deficient postnatal growth was associated with poor neurologic outcome for AGA and SGA preterm infants. CU growth does not add additional benefits. Regardless of type of postnatal growth, SGA infants showed behavioral problems and cognitive deficiency.
Assuntos
Transtorno do Deficit de Atenção com Hiperatividade/etiologia , Paralisia Cerebral/etiologia , Transtornos Cognitivos/etiologia , Desenvolvimento Fetal , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido Pequeno para a Idade Gestacional/crescimento & desenvolvimento , Deficiências da Aprendizagem/etiologia , Transtorno do Deficit de Atenção com Hiperatividade/diagnóstico , Paralisia Cerebral/diagnóstico , Criança , Pré-Escolar , Transtornos Cognitivos/diagnóstico , Feminino , Seguimentos , Humanos , Lactente , Recém-Nascido , Recém-Nascido Prematuro/psicologia , Recém-Nascido Pequeno para a Idade Gestacional/psicologia , Deficiências da Aprendizagem/diagnóstico , Masculino , Testes Neuropsicológicos , Aumento de PesoRESUMO
OBJECTIVES: To determine whether small head circumference (HC) or birth weight (BW) or both are associated with neonatal and long-term neurologic outcome in very preterm infants. STUDY DESIGN: All 2442 live births from the 1997 Epipage study between 26 and 32 weeks of gestational age in 9 regions of France were analyzed. A total of 1395 were tested at age 5 years for cognitive performance and 1315 with school performance reports at age 8 years. Symmetric growth restriction (SGR) was defined by HC and BW <20th percentile and in the same percentile range, and asymmetric growth restriction by at least 1 of HC and BW <20th percentile and the other in a higher decile range. There were 2 forms of asymmetric growth restriction: head growth restriction (HGR) and weight growth restriction (WGR). Appropriate for gestational age was defined by both BW and HC >20th percentile. RESULTS: Compared with appropriate for gestational age, SGR was significantly associated with neonatal mortality (aOR 2.99, 95% CI 1.78-5.03), moderate and severe cognitive deficiency (aOR 1.65, 95% CI 1.01-2.71 and aOR 2.61, 95% CI 1.46-4.68, respectively), and poor school performance (aOR 1.79; 95% CI 1.13-2.83). HGR was significantly associated with severe cognitive deficiency (aOR 2.07, 95% CI 1.15-3.74). WGR was not significantly associated with cognitive or school performance despite higher rates of neonatal morbidity. CONCLUSIONS: SGR in preterm infants was associated with neonatal mortality and impaired cognitive and school performance. The outcome of asymmetric growth restriction differed according to HC. HGR was associated with impaired cognitive function; WGR was not.
Assuntos
Retardo do Crescimento Fetal/diagnóstico , Transtornos do Crescimento/diagnóstico , Lactente Extremamente Prematuro/crescimento & desenvolvimento , Peso ao Nascer , Peso Corporal , Cefalometria , Criança , Pré-Escolar , Transtornos Cognitivos/complicações , Transtornos Cognitivos/diagnóstico , Estudos de Coortes , Feminino , Seguimentos , França , Transtornos do Crescimento/complicações , Cabeça/fisiologia , Humanos , Recém-Nascido , Masculino , Razão de Chances , Análise de RegressãoRESUMO
OBJECTIVE: To evaluate the relationship between preterm premature rupture of membranes (PPROM) and cognitive impairment in 5-year-old children born very preterm. STUDY DESIGN: The Etude Epidémiologique sur les Petits Ages Gestationnels Study is a population-based cohort of children followed up from birth to age 5 years recruited in 9 French regions in 1997. We analyzed data from singletons born between 24 and 32 weeks gestation categorized into 4 groups according to etiology of prematurity: infants born after PPROM, after idiopathic preterm labor, in a vascular context (Vasc), and to women with other complications (Other). Cognitive development at age 5 years was assessed using the Mental Processing Composite score of the Kaufman-Assessment Battery for Children. RESULTS: Among the 1051 children followed up to age 5 years, the mean Mental Processing Composite score was 93.6 ± 19.7, and 13.3% of the children (140 of 1051) had cognitive impairment. After adjustment for potential confounders, the risk of cognitive impairment among infants in the PPROM group was not significantly different than that in the idiopathic preterm labor group (OR, 1.09; 95% CI, 0.62-1.92) and the Other group (OR, 1.36; 95% CI, 0.75-2.47), but was lower than that in the Vasc group (OR, 1.86; 95% CI, 1.16-2.97). In the PPROM group, the risk of cognitive impairment was greater when the latency period (ie, time from rupture to delivery) was <3 days (OR, 2.32; 95% CI, 1.07-5.02). CONCLUSION: Preterm infants born after PPROM are not at increased risk for cognitive impairment in childhood, but the time between PPROM and birth may influence that risk.
Assuntos
Transtornos Cognitivos/etiologia , Deficiências do Desenvolvimento/etiologia , Ruptura Prematura de Membranas Fetais , Pré-Escolar , Transtornos Cognitivos/epidemiologia , Deficiências do Desenvolvimento/epidemiologia , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Gravidez , Estudos ProspectivosRESUMO
OBJECTIVE: To determine the usefulness of a neurodevelopmental assessment tool consisting of a questionnaire administered to teachers to measure the Global School Adaptation (GSA) scores of very preterm children at the age of 5 years. STUDY DESIGN: A sample of 445 very preterm children (<35 weeks of gestation) was assessed at 5 years of age using GSA and IQ scores. According to the consistency between the scores, children were determined to be well classified, intermediately classified, or misclassified. The differences between groups were assessed through univariate and multivariate logistic regression. RESULTS: The GSA score was highly or intermediately consistent with the IQ score for 89.2% of the children, and 10.8% were considered misclassified. Children with a higher GSA than IQ score had more autonomy and self-confidence (P < .01), and those with a lower GSA than IQ score had more behavioral problems (P < .01). Analysis by logistic regression showed that sex and gestational age significantly affected the consistency between the 2 scores. Thus, girls were less likely to have a lower GSA than IQ score (aOR = 0.45; 95% CI: 0.24-0.84; P = .01), and a lower gestational age significantly increased the likelihood of having a higher GSA than IQ score (for children born between 24 and 28 weeks of gestation: aOR = 2.70; 95% CI: 1.23-5.92; P = .01). CONCLUSIONS: The GSA score is a simple, inexpensive, and reliable screening tool for assessing neurodevelopment in very preterm children at 5 years of age.
Assuntos
Adaptação Psicológica , Desenvolvimento Infantil , Testes Neuropsicológicos , Inquéritos e Questionários , Pré-Escolar , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Recém-Nascido Prematuro , Masculino , Estudos Prospectivos , Instituições AcadêmicasRESUMO
OBJECTIVE: To compare 3 methods of identifying small-for-gestational-age (SGA) status in very preterm children as related to cognitive function and academic outcome. STUDY DESIGN: There were 1038 singletons in the Epipage Study, born before 33 weeks in 1997 without severe neurosensory impairment, who were classified as SGA when birth weight was below the 10th percentile according to: (1) birth weight (bw) reference: SGA(bw)/appropriate for gestational age (AGA)(bw); (2) intrauterine (intraut) reference: SGA(intraut)/AGA(intraut); and (3) intrauterine reference customized (cust) according to individual characteristics: SGA(cust)/AGA(cust). Cognitive function was assessed by the mental processing composite (MPC) score of the Kaufman Assessment Battery for Children at age 5 and academic achievement by a parental questionnaire at age 8. RESULTS: Of the children, 15% were SGA(bw), 38% were SGA(intraut), and 39% were SGA(cust). All children SGA(bw) were also SGA(intraut) and SGA(cust). MPC was <85 in 32% of children and 27% had low academic achievement. AGA(bw)/SGA(intraut) children had a significantly increased risk of MPC <85 (adjusted OR 1.74, 95% CI 1.22-2.28) or low academic achievement (adjusted OR 1.64, 95% CI 1.05-2.55) compared with AGA(bw)/AGA(intraut) children. The SGA(cust) group was only slightly different from the SGA(intraut) group. CONCLUSIONS: An intrauterine reference identified very preterm infants at risk of poor cognitive or academic outcomes better than a birth weight reference. Customization resulted in only slight modifications of the SGA group.
Assuntos
Logro , Cognição , Gráficos de Crescimento , Recém-Nascido Prematuro/psicologia , Recém-Nascido Pequeno para a Idade Gestacional/psicologia , Peso ao Nascer , Criança , Pré-Escolar , Feminino , Seguimentos , Humanos , Recém-Nascido , Masculino , Testes Psicológicos , Inquéritos e QuestionáriosRESUMO
Growth impairment is frequent in surviving newborns with congenital diaphragmatic hernia requiring a patch repair. This multicenter retrospective study included 57 newborns and showed a significant relationship between prophylactic fundoplication performed during initial diaphragmatic repair and survival without disordered growth, after adjustment for propensity score (adjusted OR 4.7 [1.2-18.5]; P=.03).