An observational study in Infant, Newborn, Infant, Low Birth Weight and Infant, Small for Gestational Age, sponsored by NICHD Neonatal Research Network. Recruiting at 31 sites in United States. Open to participants aged 18 Months to 26 Months. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by NICHD Neonatal Research Network · Observational
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month corrected age). The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:
The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Child Behavior Checklist.
A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.
Infants born at 401-1000 grams birth weight and/or \<29 weeks gestational age
Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.
Registry Cohort
Other: No Intervention
No Intervention
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Time frame: Longitudinal database currently funded through 3/31/2016
To examine the relationship between baseline characteristics and outcome
Time frame: Longitudinal database currently funded through 3/31/2016
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies
Time frame: Longitudinal database currently funded through 3/31/2016
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NICHD Neonatal Research Network