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Generic Database of Very Low Birth Weight Infants

Study acronym: GDB
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv35
  2. Secondary endpoints shortened, about 42 words
    • Collaborators: 2 to 1
    v34
  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, 2030
    v31
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 revised
    v26
  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
  10. Primary and study completion dates: Mar 2017 to Mar 2021
    • Site contacts updated at 15 of 28 sites
    v21
  11. Primary and study completion dates: Mar 2016 to Mar 2017
    • Site details revised at 5 of 28 sites
    v20
  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 2
    v18
  14. Site contacts updated at 3 of 28 sitesv17
  15. Study sites: 33 to 28v16
  16. Enrollment target: 68000 to 80000
    • Publications: 120 to 121
    v15
  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
  21. Primary and study completion dates: Mar 2011 to Mar 2016
    • Publications: 116 to 120
    v10
  22. Collaborators expanded, about 6 wordsv9
  23. Publications: 76 to 116v8
  24. Study sites revised (24)v7
  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 words
    v3
  29. Enrollment target: 35000 to 68000v2 Show 7 more changesShow less
    • Study sites: 16 to 17
    • Primary completion date: Mar 2011
    • Study 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
  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
(from sponsor)		 Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
Related terms Premature Birth
Enrollment 80,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov