Registry of very low birth weight infants

Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

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
• Enrollment: 80000 (estimated)
• Ages: N/A to 14 Days
• Sex: All
• Sponsor: NICHD Neonatal Research Network (Research network)
• Locations: 31 sites (Birmingham, Alabama and 30 other locations)
• Trial ID: NCT00063063 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies utilizing similar observational registry approaches have shown success in identifying trends and improving outcomes in neonatal care.

Eligibility 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 this trial is running

Birmingham, Alabama and 30 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
• University of California - Los Angeles — Los Angeles, California, United States (Completed)
• Stanford University — Palo Alto, California, United States (Recruiting)
• University of California at San Diego — San Diego, California, United States (Completed)
• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (Recruiting)
• 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)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
• Indiana University — Indianapolis, Indiana, United States (Completed)
• University of Iowa — Iowa City, Iowa, United States (Recruiting)
• 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 New Mexico — Albuquerque, New Mexico, United States (Recruiting)
• University of Rochester — Rochester, New York, United States (Active_not_recruiting)
• RTI International — Durham, North Carolina, United States (Active_not_recruiting)
• 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)
• Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States (Active_not_recruiting)
• Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States (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 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 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

Conditions Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; NICHD Neonatal Research Network; Extremely Low Birth Weight; Prematurity