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Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Aug 31, 2026 to Jul 31, 2027
    • Study completion date: Feb 28, 2027 to Dec 31, 2027
    v19
  2. Start date: Aug 27, 2024 to Sep 26, 2024
    • Primary completion date: May 1, 2026 to Aug 31, 2026
    • Study completion date: Jun 1, 2026 to Feb 28, 2027
    v18
  3. Site details revised at 1 of 2 sitesv17
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2024 to Aug 27, 2024
    • Site details revised at 2 of 2 sites
    v16
  5. Start date: Aug 10, 2024 to Sep 1, 2024v15
Show 13 earlier versionsHide 13 earlier versions
  1. Start date: Jul 15, 2024 to Aug 10, 2024v14
  2. Primary completion date: May 2026 to May 1, 2026
    • Study completion date: Jun 2026 to Jun 1, 2026
    v13
  3. Start date: May 15, 2024 to Jul 15, 2024
    • Study sites revised (2)
    • Collaborator revised
    v12
  4. Start date: Mar 15, 2024 to May 15, 2024v11
  5. Start date: Jan 15, 2024 to Mar 15, 2024v10
  6. Start date: Oct 1, 2023 to Jan 15, 2024v9
  7. Start date: Aug 1, 2023 to Oct 1, 2023
    • Primary completion date: May 31, 2026 to May 2026
    • Study completion date: Jul 31, 2026 to Jun 2026
    v8
  8. Primary completion date: Jun 30, 2025 to May 31, 2026
    • Start date: Apr 1, 2023 to Aug 1, 2023
    • Study completion date: Mar 31, 2026 to Jul 31, 2026
    v7
  9. Primary endpoint revised
    • Eligibility criteria revised
    • Study title revised
    v6
  10. Phase: Phase 2/3 to Not applicablev5 Show 7 more changesShow less
    • Primary completion date: Jun 30, 2024 to Jun 30, 2025
    • Start date: Jul 1, 2022 to Apr 1, 2023
    • Primary endpoint revised
    • Study completion date: Dec 30, 2024 to Mar 31, 2026
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 6
    • Study description revised
  11. Phase: Not applicable to Phase 2/3v4
  12. Re-verified, no change to tracked fieldsv3
  13. Primary completion date: Jun 30, 2023 to Jun 30, 2024v2 Show 9 more changesShow less
    • Start date: Sep 1, 2021 to Jul 1, 2022
    • Primary endpoint revised
    • Enrollment target: 30 to 40
    • Study sites: 0 to 2
    • Study completion date: Aug 30, 2023 to Dec 30, 2024
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 85 words
    • Study title expanded, about 5 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.
Large for Gestational Age (LGA) infants have excess fat-mass (FM) proportion secondary to prolonged in utero exposure to an energy-rich environment. Our preliminary data suggest that excess FM proportion can be associated with oral feeding delay and a potentially modifiable therapeutic target to improve oral feeding outcomes. The objective of this study is to determine the impact of a short-term Fat-free mass (FFM)-indexed feeding on the oral intake volumes in LGA infants with oral feeding difficulties.
Trial Details
NCT Number NCT04599010
Lead Sponsor Nemours Children's Clinic
Collaborators: Emory University
Conditions
(from sponsor)		 Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
Related terms Infant Nutrition Disorders
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov