Registry of very low birth weight infants
Official title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Run by NICHD Neonatal Research Network · NCT00063063 · Data updated 2026-11-12
This study collects information about very low birth weight infants and their mothers to see what factors affect their health and improve care for these fragile babies.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 14 Days |
| Sex | All |
| Enrollment | 80000 (estimated) |
| Sponsor | NICHD Neonatal Research Network Research network |
| Locations | 31 sites (Birmingham, Alabama and 30 other locations) |
| Status | Recruiting |
| Started | April 1, 1987 |
| Main results expected | March 31, 2030 |
| Study ends | March 31, 2030 |
| Registry record updated | March 16, 2026 |
| Trial ID | NCT00063063 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants born at NICHD NRN centers with a birth weight between 401 and 1000 grams or a gestational age of less than 29 weeks.
✕Probably not a fit
Patients who are not very low birth weight infants, specifically those over 1000 grams or older than 29 weeks gestational age, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The Generic Database (GDB) is a registry that collects observational data on very low birth weight infants born at NICHD Neonatal Research Network centers. It gathers baseline information on mothers and infants, including demographics, health history, and treatment outcomes. The data is analyzed to identify trends and associations that can inform future research and improve care for these vulnerable infants. The GDB aims to provide a comprehensive understanding of the factors affecting the health of very low birth weight infants in neonatal intensive care units.
Why it matters
Potential benefit: If successful, this registry could lead to improved treatment strategies and outcomes for very low birth weight infants.
How similar studies have gone: Other studies utilizing similar observational registry approaches have shown success in identifying trends and improving outcomes in neonatal care.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Infants inborn at NICHD NRN centers that are: * 401-1000 grams birth weight, and/or * 20 0/7 to 28 6/7 weeks (\<29 weeks) gestational age * Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB. Exclusion Criteria: * Infants \>1,000 grams birth weight and/or \>29 weeks gestational age Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.
Where it's running
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University of Alabama at Birmingham
Birmingham, Alabama, United States Recruiting -
Stanford University
Palo Alto, California, United States Recruiting -
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States Recruiting -
Emory University
Atlanta, Georgia, United States Recruiting -
University of Iowa
Iowa City, Iowa, United States Recruiting -
University of New Mexico
Albuquerque, New Mexico, United States Recruiting
Show 25 more locations
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Duke University
Durham, North Carolina, United States Recruiting -
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States Recruiting -
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States Recruiting -
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States Recruiting -
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States Recruiting -
University of Texas Health Science Center at Houston
Houston, Texas, United States Recruiting -
University of Utah
Salt Lake City, Utah, United States Recruiting -
University of California - Los Angeles
Los Angeles, California, United States Completed -
University of California at San Diego
San Diego, California, United States Completed -
Yale University
New Haven, Connecticut, United States Completed -
George Washington University
Washington D.C., District of Columbia, United States Completed -
University of Miami
Miami, Florida, United States Completed -
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States Not yet recruiting -
Indiana University
Indianapolis, Indiana, United States Completed -
Tufts Medical Center
Boston, Massachusetts, United States Completed -
Harvard University
Cambridge, Massachusetts, United States Completed -
Wayne State University
Detroit, Michigan, United States Completed -
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, United States Not yet recruiting -
Children's Mercy Hospital
Kansas City, Missouri, United States Completed -
University of Rochester
Rochester, New York, United States Active not recruiting -
RTI International
Durham, North Carolina, United States Active not recruiting -
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States Active not recruiting -
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States Active not recruiting -
University of Tennessee
Memphis, Tennessee, United States Completed -
University of Vermont
Burlington, Vermont, United States Completed
Study contacts
- Principal investigator: Abbot R Laptook, MD — Brown University, Women & Infants Hospital of Rhode Island
- Study coordinator: Ravi M Patal, MD
- Email: rmpatel@emory.edu
- Phone: 404-727-5905
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.