Generic Database of Very Low Birth Weight Infants

Recruiting now

Conditions studied: Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

In brief

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Key facts

Study ID

NCT00063063

Run by

NICHD Neonatal Research Network

People needed

80000

Starts

1987-04-01

Expected to finish

2030-03-31

Last updated by the study team

2026-03-16

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States (enrolling)
• Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• University of New Mexico — Albuquerque, New Mexico, United States (enrolling)
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (enrolling)
• University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
• University of Rochester — Rochester, New York, United States
• RTI International — Durham, North Carolina, United States
• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States
• Brown University, Women & Infants Hospital of Rhode Island — Providence, Rhode Island, United States
• University of Tennessee — Memphis, Tennessee, United States
• University of Vermont — Burlington, Vermont, United States
• University of California - Los Angeles — Los Angeles, California, United States
• University of California at San Diego — San Diego, California, United States
• Yale University — New Haven, Connecticut, United States
• George Washington University — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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