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NCT04599010 · ClinicalTrials.gov registry record · NA
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
A NA study of Body Composition and Nutrition Disorder, Infant, sponsored by Nemours Children's Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT04599010: Recruiting NA study of Body Composition and Nutrition Disorder, Infant, sponsored by Nemours Children's Clinic.
NCT04599010 is a NA study of Body Composition and Nutrition Disorder, Infant that is actively recruiting participants, run by Nemours Children's Clinic. The registered enrollment target is 40 participants, below the 114-participant average among 20 other Body Composition trials with a reported enrollment target (65% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04599010, a NA study of Body Composition and Nutrition Disorder, Infant, is actively recruiting participants, sponsored by Nemours Children's Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days
Conditions Studied
Interventions
- OTHER Dietary intervention
Study Locations (2)
Florida
- Nemours Children's Hospital - Orlando
Georgia
- Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-09-26 |
| Est. Completion | 2027-02-28 |
| Phase | NA |
What NCT04599010 shows while recruiting
NCT04599010 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 114-participant average among 20 other Body Composition trials with a reported enrollment target (65% lower).
The record links to 3 conditions, with Body Composition appearing as the primary indexed condition, and to 1 intervention - of which Dietary intervention is the first listed.
NCT04599010 reports a single indexed study location in Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT04599010 about?
NCT04599010 is a clinical study titled "Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty". 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 imp...
What is the current status of trial NCT04599010?
This trial is currently recruiting. It is a NA study. The enrollment target is 40 participants. The study started on 2024-09-26. Estimated completion is 2027-02-28.
What conditions does trial NCT04599010 study?
This clinical trial studies the following conditions: Body Composition, Nutrition Disorder, Infant, Feeding; Difficult, Newborn.
What interventions are being tested in trial NCT04599010?
The interventions under investigation include: Dietary intervention (OTHER).
Who is sponsoring clinical trial NCT04599010?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04599010 being conducted?
This trial has 2 study locations across Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Body Composition
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04599010's enrollment target sits among peer trials
40 14th of 20 higher than 5 of 20 other Body Composition trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Body Composition trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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