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Clinical Trials in Mexico / NCT00063063
Recruiting Observational

Generic Database of Very Low Birth Weight Infants

NCT00063063 · tracked via the Priya Life Science Mexico tracker
Sponsor
NICHD Neonatal Research Network
Phase
Observational
Started
1987-04-01
Last updated
2026-03-16

Condition(s) studied

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Premature

Investigational drug(s) / intervention(s)

No Intervention

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
14 Days
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner — Longitudinal database currently funded through 3/31/2030
    To maintain a registry of baseline and outcome data for VLBW infants with data collected

Trial sites (31)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
University of California - Los Angeles Los Angeles California Completed
Stanford University Palo Alto California Recruiting
University of California at San Diego San Diego California Completed
Sharp Mary Birch Hospital for Women & Newborns San Diego California Recruiting
Yale University New Haven Connecticut Completed
George Washington University Washington D.C. District of Columbia Completed
University of Miami Miami Florida Completed
Emory University Atlanta Georgia Recruiting
Northwestern Lurie Children's Hospital of Chicago Chicago Illinois Not Yet Recruiting
Indiana University Indianapolis Indiana Completed
University of Iowa Iowa City Iowa Recruiting
Tufts Medical Center Boston Massachusetts Completed
Harvard University Cambridge Massachusetts Completed
Wayne State University Detroit Michigan Completed
University of Mississippi Medical Center - Children's of Mississippi Jackson Mississippi Not Yet Recruiting
Children's Mercy Hospital Kansas City Missouri Completed
University of New Mexico Albuquerque New Mexico Recruiting
University of Rochester Rochester New York Active Not Recruiting
RTI International Durham North Carolina Active Not Recruiting
Duke University Durham North Carolina Recruiting
Cincinnati Children's Medical Center Cincinnati Ohio Recruiting
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio Recruiting
Research Institute at Nationwide Children's Hospital Columbus Ohio Active Not Recruiting
Univeristy of Pennsylvania Philadelphia Pennsylvania Recruiting
Brown University, Women & Infants Hospital of Rhode Island Providence Rhode Island Active Not Recruiting
University of Tennessee Memphis Tennessee Completed
University of Texas Southwestern Medical Center at Dallas Dallas Texas Recruiting
University of Texas Health Science Center at Houston Houston Texas Recruiting
University of Utah Salt Lake City Utah Recruiting
University of Vermont Burlington Vermont Completed

More NICHD Neonatal Research Network trials in Mexico

Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial Recruiting
Neonatal Platelet Transfusion Threshold Trial Recruiting
Follow-up Visit of High Risk Infants Recruiting
Continued Pressure for Alveolar Protection (CPAP Trial) Recruiting
The Budesonide in Babies (BiB) Trial Active, not recruiting

Other trials for the same condition

Follow-up Visit of High Risk Infants Recruiting
Management of the PDA Trial Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00063063 on ClinicalTrials.gov ↗ ← All trials in Mexico