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NCT04599010

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

Recruiting now NA Last updated 30 May 2025
What this trial tests

NA trial testing Dietary intervention in Body Composition in 40 participants. Currently enrolling.

Timeline
26 September 2024
Primary endpoint
31 August 2026
28 February 2027

Quick facts

Lead sponsorNemours Children's Clinic
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment40
Start date26 September 2024
Primary completion31 August 2026
Estimated completion28 February 2027
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Nemours Children's Clinic

Who can join

Adults 1 Week to 10 Weeks, any sex, with Body Composition or Feeding; Difficult, Newborn. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Oral feeding challenges of infants of diabetic mothers.
    Dietrich LJ. · · 2024 · PMID 39315360 · DOI 10.3389/fped.2024.1459197

Verify or expand the search:

Other trials of Dietary intervention

Trials testing the same drug.

Other recruiting trials for Body Composition

Currently open trials in the same condition.

Other Nemours Children's Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04599010.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing