Cerebral injury and retinopathy as risk factors for blindness in extremely preterm infants.
Benjamin M Honan, Scott A McDonald, Colm P Travers...
https://pubmed.ncbi.nlm.nih.gov/39332892/Actively Recruiting
Led by NICHD Neonatal Research Network · Updated on 2026-03-16
80000
Participants Needed
31
Research Sites
N/A
Total Duration
Researchers are maintaining a registry called the Generic Database GDB to collect data on very low birth weight infants born alive at NICHD Neonatal Research Network NRN centers. This registry gathers baseline and outcome information on both mothers and infants, focusing on infants weighing between 401 and 1000 grams or born before 29 weeks gestation. The collected data is not linked to a specific disease or treatment but is used to find associations and trends to support future research trials. The data collected includes demographics, maternal health, labor and delivery details, infant health status at birth, and medical outcomes such as respiratory support, infections, and mortality. Baseline information is collected soon after NICU admission, and outcome data is gathered at hospital discharge or death. The registry includes infants enrolled in other NRN trials or observational studies, allowing the inclusion of some infants outside the primary weight and gestational age criteria. Participants are observed without intervention, with data collection occurring throughout their hospital stay. Researchers collect detailed medical and demographic information from medical records and track outcomes over time. The main goal is to maintain a uniform, longitudinal database of very low birth weight infants to support analysis of treatment patterns and health outcomes. This registry has been active since 1987 and is funded through March 2030.
CONDITIONS
Generic Database of Very Low Birth Weight Infants
R
Ravi M Patal, MD
A
Abhik Das, PhD
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NICHD Neonatal Research Network
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Data is collected soon after admission to the NICU
Duration - Until hospital discharge or death
Participants who undergo routine care are observed to collect baseline and outcome data including health status and medical outcomes.
Data is collected at discharge or death
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor