Infant, NewbornGDBNCT00063063
Generic Database of Very Low Birth Weight Infants
An observational study of Infant, Newborn and Infant, Low Birth Weight, run by NICHD Neonatal Research Network at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
- How many people
- 80,000 participants
- Where
- 31 sitesUnited States
- Study dates
- 1 Apr 1987to 31 Mar 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 days
- All sexes
- No healthy volunteers
- Child
Study population: Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or <29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 1 country. Contact the study team or a site near you to ask about taking part.
31 sites in 1 country
United States31 sites, 15 recruiting
- Recruiting
University of New Mexico
Albuquerque, New Mexico, 87131
Kristi L. Watterberg, MD
Kristi L. Watterberg, MD
- Recruiting
Emory University
Atlanta, Georgia, 30303
David P Carlton, MD
David P Carlton, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Waldemar A. Carlo, MD
Waldemar A. Carlo, MD
- Completed
Tufts Medical Center
Boston, Massachusetts, 02111
- Completed
University of Vermont
Burlington, Vermont, 05405
- Completed
Harvard University
Cambridge, Massachusetts, 02138
- Not yet recruiting
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Aaron Hamvas, MD
Aaron Hamvas, MD
- Recruiting
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267
Brenda Poindexter, MD MS
Brenda Poindexter, MD MS
- Recruiting
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Michele C. Walsh, MD MS
Michele C. Walsh, MD MS
- Active, not recruiting
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235
Myra H Wyckoff, MD
Myra H Wyckoff, MD
- Completed
Wayne State University
Detroit, Michigan, 48201
- Active, not recruiting
RTI International
Durham, North Carolina, 27705
- Recruiting
Duke University
Durham, North Carolina, 27710
C. Michael Cotten, MD, MHS
C. Michael Cotten, MD, MHS
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Jon E. Tyson, MD MPH
Jon E. Tyson, MD MPH
- Completed
Indiana University
Indianapolis, Indiana, 46202
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Edward F. Bell, MD
Edward F. Bell, MD
- Not yet recruiting
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, 39216
Abhay Bhatt, MD
Abhay Bhatt, MD
- Completed
Children's Mercy Hospital
Kansas City, Missouri, 64108
- Completed
University of California - Los Angeles
Los Angeles, California, 90025
- Completed
University of Tennessee
Memphis, Tennessee, 38163
- Completed
University of Miami
Miami, Florida, 33136
- Completed
Yale University
New Haven, Connecticut, 06504
- Recruiting
Stanford University
Palo Alto, California, 94304
Krisa P. Van Meurs, MD
Krisa P. Van Meurs, MD
- Recruiting
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104
Eric Eichenwald, MD
Eric Eichenwald, MD
- Active, not recruiting
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
- Active, not recruiting
University of Rochester
Rochester, New York, 14642
- Recruiting
University of Utah
Salt Lake City, Utah, 84108
Bradley Yoder, MD
Bradley Yoder, MD
- Completed
University of California at San Diego
San Diego, California, 92103-8774
- Recruiting
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123
Anup Katheria, MD
Anup Katheria, MD
- Completed
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
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.
Read the detailed description
The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal intensive care units.
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"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:
- Demographics of mother and infant
- Mother's health (e.g., pregnancy history and complications)
- Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
- Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
- Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).
These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.
Informed Consent: As required by local IRBs.
Secondary Studies include:
- The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 0/7 - 28 6/7 weeks' gestation and its associated factors at Network sites.
- Conditions
- Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
- Being tested
- No Intervention
- Keywords
- NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
| Study group | Role | What they receive |
|---|---|---|
| Registry Cohort | Registry Cohort Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
To maintain a registry of baseline and outcome data for VLBW infants with data collected
Measured: Longitudinal database currently funded through 3/31/2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2003 (estimated)
- Study start1 Apr 1987
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (121)Papers the sponsor has linked to this study.
- Other trials for Infant, NewbornStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NICHD Neonatal Research Network
- Sponsor type
- Research network
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Abbot R Laptook, MD, Principal investigator, Brown University, Women & Infants Hospital of Rhode IslandAnna Maria Hibbs, MD, MSCE, FAAP, Principal investigator, Case Western Reserve University, Rainbow Babies and Children's HospitalC. Michael Cotten, MD, Principal investigator, Duke UniversityRavi M Patel, MD, MSc, Study chair, Emory UniversityAbhik Das, PhD, Principal investigator, RTI InternationalKrisa P Van Meurs, MD, Principal investigator, Stanford UniversityStephanie Merhar, MD MS, Principal investigator, Children's Hospital Medical Center, CincinnatiWaldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063063
- Sponsor's protocol ID
- NICHD-NRN-0001
- Other IDs
- U24HD095254, UG1HD068263, UG1HD034216, UG1HD021364, UG1HD027853, UG1HD027851, UG1HD053109, UG1HD112079
- Acronym
- GDB
- Status last verified
- Mar 2026
- First submitted
- 19 Jun 2003
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Strand M, Jobe AH. The multiple negative randomized controlled trials in perinatology--why? Semin Perinatol. 2003 Aug;27(4):343-50. doi: 10.1016/s0146-0005(03)00042-9.
PubMed 14510325Tyson JE, Stoll BJ. Evidence-based ethics and the care and outcome of extremely premature infants. Clin Perinatol. 2003 Jun;30(2):363-87. doi: 10.1016/s0095-5108(03)00028-9.
PubMed 12875360Wright LL. How to develop and manage a successful research network. Semin Pediatr Surg. 2002 Aug;11(3):175-80; discussion 180. doi: 10.1053/spsu.2002.33740. No abstract available.
PubMed 12145760Wright LL, McNellis D. National Institute of Child Health and Human Development (NICHD)-sponsored Perinatal Research Networks. Semin Perinatol. 1995 Apr;19(2):112-23. doi: 10.1016/s0146-0005(05)80031-x. No abstract available.
PubMed 7604302Adams-Chapman I, Hansen NI, Stoll BJ, Higgins R; NICHD Research Network. Neurodevelopmental outcome of extremely low birth weight infants with posthemorrhagic hydrocephalus requiring shunt insertion. Pediatrics. 2008 May;121(5):e1167-77. doi: 10.1542/peds.2007-0423. Epub 2008 Apr 7.
PubMed 18390958Ambalavanan N, Carlo WA, Bobashev G, Mathias E, Liu B, Poole K, Fanaroff AA, Stoll BJ, Ehrenkranz R, Wright LL; National Institute of Child Health and Human Development Neonatal Research Network. Prediction of death for extremely low birth weight neonates. Pediatrics. 2005 Dec;116(6):1367-73. doi: 10.1542/peds.2004-2099.
PubMed 16322160Benjamin DK Jr, Stoll BJ, Fanaroff AA, McDonald SA, Oh W, Higgins RD, Duara S, Poole K, Laptook A, Goldberg R; National Institute of Child Health and Human Development Neonatal Research Network. Neonatal candidiasis among extremely low birth weight infants: risk factors, mortality rates, and neurodevelopmental outcomes at 18 to 22 months. Pediatrics. 2006 Jan;117(1):84-92. doi: 10.1542/peds.2004-2292.
PubMed 16396864Broitman E, Ambalavanan N, Higgins RD, Vohr BR, Das A, Bhaskar B, Murray K, Hintz SR, Carlo WA; National Institute of Child Health and Human Development Neonatal Research Network. Clinical data predict neurodevelopmental outcome better than head ultrasound in extremely low birth weight infants. J Pediatr. 2007 Nov;151(5):500-5, 505.e1-2. doi: 10.1016/j.jpeds.2007.04.013. Epub 2007 Jul 12.
PubMed 17961693Castro L, Yolton K, Haberman B, Roberto N, Hansen NI, Ambalavanan N, Vohr BR, Donovan EF. Bias in reported neurodevelopmental outcomes among extremely low birth weight survivors. Pediatrics. 2004 Aug;114(2):404-10. doi: 10.1542/peds.114.2.404.
PubMed 15286223Cole CR, Hansen NI, Higgins RD, Ziegler TR, Stoll BJ; Eunice Kennedy Shriver NICHD Neonatal Research Network. Very low birth weight preterm infants with surgical short bowel syndrome: incidence, morbidity and mortality, and growth outcomes at 18 to 22 months. Pediatrics. 2008 Sep;122(3):e573-82. doi: 10.1542/peds.2007-3449.
PubMed 18762491Cotten CM, Oh W, McDonald S, Carlo W, Fanaroff AA, Duara S, Stoll B, Laptook A, Poole K, Wright LL, Goldberg RN; NICHD Neonatal Research Network. Prolonged hospital stay for extremely premature infants: risk factors, center differences, and the impact of mortality on selecting a best-performing center. J Perinatol. 2005 Oct;25(10):650-5. doi: 10.1038/sj.jp.7211369.
PubMed 16079906Cotten CM, Taylor S, Stoll B, Goldberg RN, Hansen NI, Sanchez PJ, Ambalavanan N, Benjamin DK Jr; NICHD Neonatal Research Network. Prolonged duration of initial empirical antibiotic treatment is associated with increased rates of necrotizing enterocolitis and death for extremely low birth weight infants. Pediatrics. 2009 Jan;123(1):58-66. doi: 10.1542/peds.2007-3423.
PubMed 19117861Da Costa D, Bann CM, Hansen NI, Shankaran S, Delaney-Black V; National Institute of Child Health and Human Development Neonatal Research Network. Validation of the Functional Status II questionnaire in the assessment of extremely-low-birthweight infants. Dev Med Child Neurol. 2009 Jul;51(7):536-44. doi: 10.1111/j.1469-8749.2009.03318.x.
PubMed 19459909Demarini S, Dollberg S, Hoath SB, Ho M, Donovan EF. Effects of antenatal corticosteroids on blood pressure in very low birth weight infants during the first 24 hours of life. J Perinatol. 1999 Sep;19(6 Pt 1):419-25. doi: 10.1038/sj.jp.7200245.
PubMed 10685271Dollberg S, Demarini S, Donovan EF, Hoath SB. Maturation of thermal capabilities in preterm infants. Am J Perinatol. 2000;17(1):47-51. doi: 10.1055/s-2000-7293.
PubMed 10928604