Unimpaired outcomes for extremely low birth weight infants at 18 to 22 months.
Regina A Gargus, Betty R Vohr, Jon E Tyson...
https://pubmed.ncbi.nlm.nih.gov/19564290/Actively Recruiting
Led by NICHD Neonatal Research Network · Updated on 2026-07-01
68000
Participants Needed
31
Research Sites
N/A
Total Duration
This research evaluates neurodevelopment in surviving extremely low birth-weight infants born at participating centers. The study aims to identify maternal and neonatal risk factors that may influence infant development by assessing motor skills, cognitive abilities, language, behavior, and the use of special support services. It also examines growth, socioeconomic status, mortality, and medical conditions in this high-risk infant population. Participants undergo detailed neurodevelopmental, neurosensory, and functional assessments at 22 to 26 months corrected age. The evaluations include demographic and socioeconomic data, medical history, medication use, growth measurements, neurological exams, and standardized developmental tests such as the Bayley Scales of Infant Development and the Child Behavior Checklist. A reference group of healthy term infants is also assessed to provide comparison data and ensure consistency in scoring. Throughout the study, data is collected prospectively to maintain a registry of baseline and outcome information for very low birth-weight infants. Researchers monitor developmental outcomes and related factors longitudinally to support future research and hypothesis generation. Participation involves scheduled evaluations and standardized assessments conducted at specified corrected ages, with the study continuing through March 2030.
CONDITIONS
Follow-up Visit of High Risk Infants
S
Susan R Hintz, MD, MS Epi
A
Abhik Das, PhD
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NICHD Neonatal Research Network
Lead Sponsor
National Center for Research Resources (NCRR)
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening visit
Duration - At 22 to 26 months corrected age
Participants undergo neurodevelopmental, neurosensory, and functional assessments at 22 to 26 months corrected age. This includes medical history, growth data, neurological exams, and standardized developmental tests like the Bayley Scales of Infant Development and Child Behavior Checklist.
1 to 2 evaluation visits
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/15713907/NICHD Neonatal Research Network
Lead Sponsor
National Center for Research Resources (NCRR)
Collaborating Sponsor