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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Nemours Children's Clinic
Study ID
NCT04599010
Status
Recruiting
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Conditions

  • Body Composition
  • Feeding; Difficult, Newborn
  • Nutrition Disorder, Infant

Eligibility Criteria

Sex
ALL
Age
1 Week - 10 Weeks
Healthy Volunteers
Accepted

Interventions

  • Dietary intervention — OTHER
    energy-restricted diet appropriate for resting metabolic rate using FFM as proxy

Study Details

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.

Key Dates

Start date
Sep 26, 2024
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FFM-indexed feeding
    In FFM-indexed feeding, there will be a permissive feeding volume restriction to 150 ± 10 mL/kg (FFM)/day without increasing the milk calorie density or changing the type of formula milk for 2 weeks in the intervention group
  • Active Comparator: Standard feeding
    The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period

Primary Outcome Measure

Time from study entry to independent oral feeding [ Time Frame: Before or at NICU-discharge ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Nemours Children's HospitalOrlandoFlorida32827
Sreekanth Viswanathan
[email protected]
407-697-7603
Emory UniversityAtlantaGeorgia30329
Kera McNelis, MD
[email protected]

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