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Follow-up Visit of High Risk Infants

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

Record History

  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 31v25 Show 1 more changeShow less
    • Study sites: 28 to 31
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 wordsv21 Show 1 more changeShow less
    • Study description shortened, about 14 words

    See this version in full on ClinicalTrials.gov ↗

  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 wordsv17 Show 2 more changesShow less
    • Study sites: 29 to 28
    • Study description expanded, about 108 words

    See this version in full on ClinicalTrials.gov ↗

  8. Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to NICHD Neonatal Research Network Collaborators: 1 to 2v16 Show 1 more changeShow less
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  9. Site contacts updated at 3 of 29 sitesv15
  10. Study sites: 24 to 29 Eligibility criteria revised · Secondary endpoints: details revised at 2 of 2 entries · Publications: 73 to 76 · 2 morev14 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

    See this version in full on ClinicalTrials.gov ↗

  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 See this version in full on ClinicalTrials.gov ↗
  14. Primary and study completion dates: Mar 2011 to Mar 2016 Publications: 68 to 73v9 Show 1 more changeShow less
    • Publications: 68 to 73

    See this version in full on ClinicalTrials.gov ↗

  15. Collaborators expanded, about 6 wordsv8 See this version in full on ClinicalTrials.gov ↗
  16. Publications: 20 to 68v7 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (24) Eligibility criteria shortened, about 3 wordsv6 Show 1 more changeShow less
    • Eligibility criteria shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  18. Study sites: 16 to 24 Study description shortened, about 63 wordsv5 Show 1 more changeShow less
    • Study description shortened, about 63 words

    See this version in full on ClinicalTrials.gov ↗

  19. Enrollment target: 68000 Study sites: 13 to 16 · Primary and study completion dates: Mar 2011 · Eligibility criteria expanded, about 104 words · 1 morev4 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

    See this version in full on ClinicalTrials.gov ↗

  20. Re-verified, no change to tracked fieldsv3
  21. Publications: 6 to 20v2 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 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 Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
Enrollment 68,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov