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Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science

Study acronym: DHREAMS
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from Columbia University

Record History

  1. Primary and study completion pushed from Sep 2026 to Sep 2027 Site details revised at 10 of 14 sites · Publications: details revised at 17 of 17 entries · Eligibility criteria expanded, about 2 words Show 3 more changesShow less
    • Site details revised at 10 of 14 sites
    • Publications: details revised at 17 of 17 entries
    • Eligibility criteria expanded, about 2 words
  2. Primary and study completion dates: Nov 2025 to Sep 2026v23
  3. Site details revised at 8 of 14 sitesv22
  4. Site contacts updated at 1 of 14 sitesv21
  5. 2 versions Re-verified since Oct 20, 2021, no change to tracked fieldsv19-v20
Show 17 earlier versionsHide 17 earlier versions
  1. Enrollment target: 2020 to 3000 Study sites: 12 to 14 · Publications: 14 to 17v18 Show 2 more changesShow less
    • Study sites: 12 to 14
    • Publications: 14 to 17

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Feb 16, 2019, no change to tracked fieldsv16-v17
  3. Primary and study completion dates: Nov 2020 to Nov 2025 Primary endpoints: 3 to 1 · Secondary endpoints revised (2) · Collaborators: 1 to 2 · 1 morev15 Show 4 more changesShow less
    • Primary endpoints: 3 to 1
    • Secondary endpoints revised (2)
    • Collaborators: 1 to 2
    • Publications: 9 to 14

    See this version in full on ClinicalTrials.gov ↗

  4. Primary endpoints revised (3) Secondary endpoints revised (2) · Study description shortened, about 114 wordsv14 Show 2 more changesShow less
    • Secondary endpoints revised (2)
    • Study description shortened, about 114 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 10 to 12 Publications: 7 to 9v13 Show 1 more changeShow less
    • Publications: 7 to 9

    See this version in full on ClinicalTrials.gov ↗

  6. Primary endpoints: 2 to 3 Secondary endpoints revised (2)v12 Show 1 more changeShow less
    • Secondary endpoints revised (2)

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  7. Enrollment target: 500 to 2020 Primary completion date: Nov 2012 to Nov 2020 · Study sites: 7 to 10 · Completion date: Nov 2013 to Nov 2020 · 2 morev11 Show 5 more changesShow less
    • Primary completion date: Nov 2012 to Nov 2020
    • Study sites: 7 to 10
    • Completion date: Nov 2013 to Nov 2020
    • Secondary endpoints: details revised at 1 of 2 entries
    • Publications: 1 to 7

    See this version in full on ClinicalTrials.gov ↗

  8. Re-verified, no change to tracked fieldsv10
  9. Start date: Nov 2008 to Jun 2005v9
  10. Completion date: Nov 2012 to Nov 2013v8
  11. Re-verified, no change to tracked fieldsv7
  12. Study sites: 8 to 7v6
  13. Re-verified, no change to tracked fieldsv5
  14. Study sites: 6 to 8v4
  15. Eligibility criteria expanded, about 6 wordsv3 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 5 to 6 Study title expanded, about 1 wordv2 Show 1 more changeShow less
    • Study title expanded, about 1 word

    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 goal of this study is to identify genes that convey susceptibility to congenital diaphragmatic hernia in humans. The identification of such genes, and examination of their structure and function, will enable a delineation of molecular pathogenesis and, ultimately, prevention or treatment of congenital diaphragmatic hernia. There are many different possible modes of inheritance for congenital anomalies, including autosomal dominant, autosomal recessive, and multifactorial. Multi-factorial inheritance is responsible for many common medical disorders, including hypertension, myocardial infarction, diabetes and cancer. This type of inheritance pattern appears to involve environmental factors as well as a combination of genetic variations that together can predispose to or produce congenital anomalies, such as congenital diaphragmatic hernia. Our study is designed to establish a small, well-defined genetic resource consisting of 1) Nuclear families suitable for linkage analysis by parametric,non-parametric (e.g. sib pairs, TDT) and association techniques, 2) Individuals with congenital diaphragmatic hernia who can be directly screened for allelic variation in candidate genes, and 3) Individuals who can serve as controls (are unaffected by congenital diaphragmatic hernia). Neonates and their families will be collected from homogenous and heterogeneous populations. By characterizing diverse populations, it should be possible to increase the likelihood of demonstration of genetic variation in selected candidate genes that can then be used in association and linkage studies in individual subjects with congenital diaphragmatic hernia.
Trial Details
NCT Number NCT00950118
Lead Sponsor Columbia University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)
Conditions Congenital Diaphragmatic Hernia
Enrollment 3,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov