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Follow-up Visit of High Risk Infants

Study acronym: FU
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. 2 versions Re-verified since Jun 19, 2026, no change to tracked fieldsv29-v30
  2. Study Identification, Study Status, Arms and Interventionsv28
  3. Start date: Jan 1993 to Apr 1, 1993v27
  4. Re-verified, no change to tracked fieldsv26
  5. Primary and study completion dates: Mar 2023 to Mar 31, 2030
    • Study sites: 28 to 31
    v25
Show 23 earlier versionsHide 23 earlier versions
  1. Re-verified, no change to tracked fieldsv24
  2. Primary and study completion dates: Mar 2021 to Mar 2023v23
  3. Re-verified, no change to tracked fieldsv22
  4. Eligibility criteria shortened, about 11 words
    • Study description shortened, about 14 words
    v21
  5. 2 versions Re-verified since Nov 7, 2017, no change to tracked fieldsv19-v20
  6. Site contacts updated at 19 of 28 sitesv18
  7. Primary and study completion dates: Mar 2016 to Mar 2021
    • Study sites: 29 to 28
    • Study description expanded, about 108 words
    v17
  8. Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to NICHD Neonatal Research Network
    • Collaborators: 1 to 2
    v16
  9. Site contacts updated at 3 of 29 sitesv15
  10. Study sites: 24 to 29v14 Show 5 more changesShow less
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 2 entries
    • Publications: 73 to 76
    • Study description shortened, about 2 words
    • Study title shortened, about 2 words
  11. 2 versions Re-verified since Jul 10, 2012, no change to tracked fieldsv12-v13
  12. Site details revised at 1 of 24 sitesv11
  13. Study sites revised (24)v10
  14. Primary and study completion dates: Mar 2011 to Mar 2016
    • Publications: 68 to 73
    v9
  15. Collaborators expanded, about 6 wordsv8
  16. Publications: 20 to 68v7
  17. Study sites revised (24)
    • Eligibility criteria shortened, about 3 words
    v6
  18. Study sites: 16 to 24
    • Study description shortened, about 63 words
    v5
  19. Enrollment target: 68000v4 Show 4 more changesShow less
    • Study sites: 13 to 16
    • Primary and study completion dates: Mar 2011
    • Eligibility criteria expanded, about 104 words
    • Study title shortened, about 1 word
  20. Re-verified, no change to tracked fieldsv3
  21. Publications: 6 to 20v2
  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 NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.
Trial Details
NCT Number NCT00009633
Lead Sponsor NICHD Neonatal Research Network
Collaborators: National Center for Research Resources (NCRR), 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 68,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov