Clinical trial Recruiting at 13 sites Observational Ages Any age to 14 Days

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.

More Infant, Newborn trials

Quick facts

Study typeObservational
AgesAny age to 14 Days
SexAll
Enrollment80000 (estimated)
SponsorNICHD Neonatal Research Network
Research network
Locations31 sites (Birmingham, Alabama and 30 other locations)
StatusRecruiting
StartedApril 1, 1987
Main results expectedMarch 31, 2030
Study endsMarch 31, 2030
Registry record updatedMarch 16, 2026
Trial IDNCT00063063 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Follow-up assessments for high-risk infants

    This study looks at how extremely low birth-weight infants develop by checking their motor skills, thinking, language, and behavior when they are about two years old, while also comparing them to healthy babies.

    Recruiting at 16 sites NICHD Neonatal Research Network · Birmingham, Alabama and 30 other locations · NCT00009633

  • Paternal gentle touch to improve newborn feeding, comfort, and blood sugar

    This will try gentle hand touch by fathers during the first six hours to see if it improves sucking, comfort, and blood glucose in newborns at risk for low blood sugar.

    Recruiting Acibadem University · Istanbul, Istanbul · NCT07302412

  • Personalized parental-voice music for preterm infants

    This pilot test compares recorded parental-voice music with quiet rest to see if it improves brain oxygenation and vital signs in preterm infants in the NICU.

    Recruiting Azienda Ospedaliera di Perugia · Perugia, PG · NCT07295106

  • Community health worker support plus guaranteed basic income for families with newborns

    This project will test whether community health workers, with or without a guaranteed basic income, help English- and Spanish-speaking Medicaid families with newborns use more health and social services and support better early child development.

    Recruiting Stanford University · Palo Alto, California · NCT07261254

  • Restore a newborn's gut microbiota using the mother's microbes.

    This will test whether giving C-section newborns bacteria from their own mother or commercial probiotics helps their gut microbiota become more like babies born vaginally.

    Recruiting at 2 sites University of Helsinki · Helsinki and 1 other locations · NCT07212361

  • Bloom Infant Probiotic: Can a probiotic help vaccines work better after early antibiotics?

    We’re testing if giving Infloran probiotic to newborns who had antibiotics in the first 28 days helps their vaccines produce stronger antibodies.

    Recruiting Phase 2 South Australian Health and Medical Research Institute · Adelaide, South Australia and 1 other locations · NCT07189390

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.