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Generic Database of Very Low Birth Weight Infants

Study acronym: GDB
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv35
  2. Secondary endpoints shortened, about 42 words Collaborators: 2 to 1v34 Show 1 more changeShow less
    • Collaborators: 2 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jan 1987 to Apr 1, 1987v33
  4. Re-verified, no change to tracked fieldsv32
  5. Study sites: 28 to 31 Primary and study completion dates: Mar 2030 to Mar 31, 2030v31 Show 1 more changeShow less
    • Primary and study completion dates: Mar 2030 to Mar 31, 2030
Show 29 earlier versionsHide 29 earlier versions
  1. Primary and study completion dates: Mar 2028 to Mar 2030v30
  2. Primary and study completion dates: Mar 2023 to Mar 2028v29
  3. Primary and study completion dates: Mar 2021 to Mar 2023v28
  4. Re-verified, no change to tracked fieldsv27
  5. Eligibility criteria revised Study description revisedv26 Show 1 more changeShow less
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  6. Secondary endpoints: details revised at 4 of 4 entriesv25
  7. Re-verified, no change to tracked fieldsv24
  8. Site contacts updated at 3 of 28 sitesv23
  9. Study description expanded, about 36 wordsv22 See this version in full on ClinicalTrials.gov ↗
  10. Primary and study completion dates: Mar 2017 to Mar 2021 Site contacts updated at 15 of 28 sitesv21 Show 1 more changeShow less
    • Site contacts updated at 15 of 28 sites
  11. Primary and study completion dates: Mar 2016 to Mar 2017 Site details revised at 5 of 28 sitesv20 Show 1 more changeShow less
    • Site details revised at 5 of 28 sites
  12. Site contacts updated at 1 of 28 sitesv19
  13. Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to NICHD Neonatal Research Network Collaborators: 1 to 2v18 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  14. Site contacts updated at 3 of 28 sitesv17
  15. Study sites: 33 to 28v16
  16. Enrollment target: 68000 to 80000 Publications: 120 to 121v15 Show 1 more changeShow less
    • Publications: 120 to 121

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv14
  18. Study sites: 29 to 33v13
  19. Study sites: 24 to 29v12
  20. Study sites revised (24)v11 See this version in full on ClinicalTrials.gov ↗
  21. Primary and study completion dates: Mar 2011 to Mar 2016 Publications: 116 to 120v10 Show 1 more changeShow less
    • Publications: 116 to 120

    See this version in full on ClinicalTrials.gov ↗

  22. Collaborators expanded, about 6 wordsv9 See this version in full on ClinicalTrials.gov ↗
  23. Publications: 76 to 116v8 See this version in full on ClinicalTrials.gov ↗
  24. Study sites revised (24)v7 See this version in full on ClinicalTrials.gov ↗
  25. Study sites: 17 to 24v6
  26. Publications: details revised at 1 of 76 entriesv5
  27. Re-verified, no change to tracked fieldsv4
  28. Eligibility criteria expanded, about 20 words Study description shortened, about 149 wordsv3 Show 1 more changeShow less
    • Study description shortened, about 149 words

    See this version in full on ClinicalTrials.gov ↗

  29. Enrollment target: 35000 to 68000 Study sites: 16 to 17 · Primary completion date: Mar 2011 · Completion date: Dec 2005 to Mar 2011 · 4 morev2 Show 7 more changesShow less
    • Study sites: 16 to 17
    • Primary completion date: Mar 2011
    • Completion date: Dec 2005 to Mar 2011
    • Eligibility criteria expanded, about 86 words
    • Study description expanded, about 146 words
    • Publications: 44 to 76
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00063063
Lead Sponsor NICHD Neonatal Research Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
Enrollment 80,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov