RESUMEN
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.
Asunto(s)
Parálisis Cerebral , Humanos , Parálisis Cerebral/epidemiología , Femenino , Preescolar , Prevalencia , Masculino , Estudios Retrospectivos , Recién Nacido , Recien Nacido Extremadamente Prematuro , Edad Gestacional , Índice de Severidad de la Enfermedad , Estados Unidos/epidemiología , Lactante , Estudios de Cohortes , Sistema de RegistrosRESUMEN
BACKGROUND: Ultrasound during antenatal care (ANC) is proposed as a strategy for increasing hospital deliveries for complicated pregnancies and improving maternal, fetal, and neonatal outcomes. The First Look study was a cluster-randomized trial conducted in the Democratic Republic of Congo, Guatemala, Kenya, Pakistan and Zambia to evaluate the impact of ANC-ultrasound on these outcomes. An additional survey was conducted to identify factors influencing women with complicated pregnancies to attend referrals for additional care. METHODS: Women who received referral due to ANC ultrasound findings participated in structured interviews to characterize their experiences. Cochran-Mantel-Haenszel statistics were used to examine differences between women who attended the referral and women who did not. Sonographers' exam findings were compared to referred women's recall. RESULTS: Among 700 referred women, 510 (71%) attended the referral. Among referred women, 97% received a referral card to present at the hospital, 91% were told where to go in the hospital, and 64% were told that the hospital was expecting them. The referred women who were told who to see at the hospital (88% vs 66%), where to go (94% vs 82%), or what should happen, were more likely to attend their referral (68% vs 56%). Barriers to attending referrals were cost, transportation, and distance. Barriers after reaching the hospital were substantial. These included not connecting with an appropriate provider, not knowing where to go, and being told to return later. These barriers at the hospital often led to an unsuccessful referral. CONCLUSIONS: Our study found that ultrasound screening at ANC alone does not adequately address barriers to referrals. Better communication between the sonographer and the patient increases the likelihood of a completed referral. These types of communication include describing the ultrasound findings, including the reason for the referral, to the mother and staff; providing a referral card; describing where to go in the hospital; and explaining the procedures at the hospital. Thus, there are three levels of communication that need to be addressed to increase completion of appropriate referrals-communication between the sonographer and the woman, the sonographer and the clinic staff, and the sonographer and the hospital. TRIAL REGISTRATION: NCT01990625 .
Asunto(s)
Complicaciones del Embarazo/diagnóstico por imagen , Atención Prenatal , Derivación y Consulta , Ultrasonografía Prenatal , Adolescente , Adulto , Instituciones de Atención Ambulatoria , República Democrática del Congo , Países en Desarrollo , Femenino , Guatemala , Humanos , Kenia , Pakistán , Embarazo , Adulto Joven , ZambiaRESUMEN
OBJECTIVE: To explore the early childhood pulmonary outcomes of infants who participated in the National Institute of Child Health and Human Development's Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial (SUPPORT), using a factorial design that randomized extremely preterm infants to lower vs higher oxygen saturation targets and delivery room continuous positive airway pressure (CPAP) vs intubation/surfactant. STUDY DESIGN: The Breathing Outcomes Study, a prospective secondary study to the Surfactant Positive Airway Pressure and Pulse Oximetry Randomized Trial, assessed respiratory morbidity at 6-month intervals from hospital discharge to 18-22 months corrected age (CA). Two prespecified primary outcomes-wheezing more than twice per week during the worst 2-week period and cough longer than 3 days without a cold-were compared for each randomized intervention. RESULTS: One or more interviews were completed for 918 of the 922 eligible infants. The incidences of wheezing and cough were 47.9% and 31.0%, respectively, and did not differ between the study arms of either randomized intervention. Infants randomized to lower vs higher oxygen saturation targets had a similar risk of death or respiratory morbidity (except for croup and treatment with oxygen or diuretics at home). Infants randomized to CPAP vs intubation/surfactant had fewer episodes of wheezing without a cold (28.9% vs 36.5%; P<.05), respiratory illnesses diagnosed by a doctor (47.7% vs 55.2%; P<.05), and physician or emergency room visits for breathing problems (68.0% vs 72.9%; P<.05) by 18-22 months CA. CONCLUSION: Treatment with early CPAP rather than intubation/surfactant is associated with less respiratory morbidity by 18-22 months CA. Longitudinal assessment of pulmonary morbidity is necessary to fully evaluate the potential benefits of respiratory interventions for neonates.
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Presión de las Vías Aéreas Positiva Contínua/métodos , Oximetría/métodos , Oxígeno/uso terapéutico , Surfactantes Pulmonares/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/terapia , Salas de Parto , Femenino , Humanos , Lactante , Recien Nacido Extremadamente Prematuro , Recién Nacido , Recien Nacido Prematuro , Masculino , Estudios Prospectivos , Encuestas y Cuestionarios , Resultado del Tratamiento , Estados UnidosRESUMEN
We conducted a theory-driven process evaluation of a cluster randomized controlled trial comparing two types of complementary feeding (meat versus fortified cereal) on infant growth in Guatemala, Pakistan, Zambia and the Democratic Republic of Congo. We examined process evaluation indicators for the entire study cohort (N = 1236) using chi-square tests to examine differences between treatment groups. We administered exit interviews to 219 caregivers and 45 intervention staff to explore why caregivers may or may not have performed suggested infant feeding behaviors. Multivariate regression analysis was used to determine the relationship between caregiver scores and infant linear growth velocity. As message recall increased, irrespective of treatment group, linear growth velocity increased when controlling for other factors (P < 0.05), emphasizing the importance of study messages. Our detailed process evaluation revealed few differences between treatment groups, giving us confidence that the main trial's lack of effect to reverse the progression of stunting cannot be explained by differences between groups or inconsistencies in protocol implementation. These findings add to an emerging body of literature suggesting limited impact on stunting of interventions initiated during the period of complementary feeding in impoverished environments. The early onset and steady progression support the provision of earlier and comprehensive interventions.
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Educación en Salud/métodos , Fenómenos Fisiológicos Nutricionales del Lactante , Cuidadores/educación , Cuidadores/psicología , Desarrollo Infantil , República Democrática del Congo , Femenino , Guatemala , Humanos , Lactante , Alimentos Infantiles , Fenómenos Fisiológicos Nutricionales del Lactante/fisiología , Entrevistas como Asunto , Masculino , Estado Nutricional , Pakistán , Evaluación de Programas y Proyectos de Salud , ZambiaRESUMEN
OBJECTIVE: To describe the Neonatal Research Network's efforts to improve the certification process for the Follow-Up Study neurologic exam and to evaluate inter-rater agreement before and after two annual training workshops. STUDY DESIGN: The Neonatal Research Network Follow-Up Study is a multi-center observational study that has examined more than 11 500 infants from 1998-2010 and born ≤26 weeks gestational age at 18-22 months corrected age for neurodevelopmental outcome. The percentages of examiners who agreed with the Gold Standard examiner on 4 neurodevelopmental outcomes on the initial training video and a test video were calculated. Consistency among examiners was assessed with the first-order agreement coefficient statistic. RESULTS: Improvements in agreement among examiners occurred between 2009 and 2010 and between initial training and test. Examiner agreement with the Gold Standard during the initial training was 83%-91% in 2009 and 89%-99% in 2010. Examiner agreement on the workshop test video increased from 2009-2010 with agreement reaching 100% for all four neurodevelopmental outcomes examined in 2010. First-order agreement coefficient values for the four neurodevelopmental outcomes on the training videos ranged from 0.64-0.82 in 2009 and 0.77-0.97 in 2010. CONCLUSIONS: We demonstrate the importance of annual certification and the benefits of evaluation and revision of certification protocols to achieve high levels of confidence in neurodevelopmental study outcomes for multi-center networks.
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Certificación/normas , Enfermedades del Prematuro/diagnóstico , Estudios Multicéntricos como Asunto/normas , Examen Neurológico/normas , Ceguera/diagnóstico , Parálisis Cerebral/diagnóstico , Certificación/métodos , Discapacidades del Desarrollo/diagnóstico , Educación , Estudios de Seguimiento , Pérdida Auditiva Bilateral/diagnóstico , Humanos , Lactante , Recién Nacido , Recien Nacido Prematuro , Estudios Multicéntricos como Asunto/métodos , Examen Neurológico/métodos , Variaciones Dependientes del Observador , Trastornos Psicomotores/diagnóstico , Estados Unidos , Grabación en VideoRESUMEN
OBJECTIVES: To compare 18- to 22-month cognitive scores and neurodevelopmental impairment (NDI) in 2 time periods using the National Institute of Child Health and Human Development's Neonatal Research Network assessment of extremely low birth weight infants with the Bayley Scales of Infant Development, Second Edition (Bayley II) in 2006-2007 (period 1) and using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley III), with separate cognitive and language scores, in 2008-2011 (period 2). STUDY DESIGN: Scores were compared with bivariate analysis, and regression analyses were run to identify differences in NDI rates. RESULTS: Mean Bayley III cognitive scores were 11 points higher than mean Bayley II cognitive scores. The NDI rate was reduced by 70% (from 43% in period 1 to 13% in period 2; P < .0001). Multivariate analyses revealed that Bayley III contributed to a decreased risk of NDI by 5 definitions: cognitive score <70 and <85, cognitive or language score <70; cognitive or motor score <70, and cognitive, language, or motor score <70 (P < .001). CONCLUSION: Whether the Bayley III is overestimating cognitive performance or whether it is a more valid assessment of emerging cognitive skills than the Bayley II is uncertain. Because the Bayley III identifies significantly fewer children with disability, it is recommended that all extremely low birth weight infants be offered early intervention services at the time of discharge from the neonatal intensive care unit, and that Bayley scores be interpreted with caution.