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NCT04599010
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
NA trial testing Dietary intervention in Body Composition in 40 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Nemours Children's Clinic |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 26 September 2024 |
| Primary completion | 31 August 2026 |
| Estimated completion | 28 February 2027 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Dietary intervention
Conditions studied
- Body Composition — all drugs for Body Composition →
- Feeding; Difficult, Newborn — all drugs for Feeding; Difficult, Newborn →
- Nutrition Disorder, Infant — all drugs for Nutrition Disorder, Infant →
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):
-
Oral feeding challenges of infants of diabetic mothers.
Dietrich LJ. · · 2024 · PMID 39315360 · DOI 10.3389/fped.2024.1459197
Verify or expand the search:
- PubMed search for NCT04599010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Nemours Children's Clinic trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04599010 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Nemours Children's Clinic
- Last refreshed: 30 May 2025
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