An interventional study of Dietary intervention in Body Composition, Feeding; Difficult, Newborn and Nutrition Disorder, Infant, sponsored by Nemours Children's Clinic. Recruiting at 2 sites in United States. Open to participants aged 1 Week to 10 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Nemours Children's Clinic · Not applicable, Interventional, and Treatment
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.
Eligible subjects will be randomized to an innovative FFM-indexed feeding or the standard feeding for up to 2 weeks. The essential component of the FFM-indexed feeding will be the difference in milk prescription dosing that we propose to set the feeding volume to index FFM rather than total mass. 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, whereas the standard feeding will include a feeding volume goal of 150 ± 10 mL/kg (body weight)/day. Infants will receive either breast milk or formula feedings per the standard feeding protocols. Body composition (PEAPOD system) and appetite-regulating hormones (ARH) levels of enrolled infants will be assessed at baseline (test-1) and at the end 2-week study intervention period (test-2). Subjects will be followed for clinical and growth outcomes until neonatal intensive care unit (NICU) discharge and through 6 months of age. Growth will be followed through 6 months of age by retrieving anthropometric measurement records from pediatricians at well-child visits (2-, 4-, 6- and 6-month visits). Parents will be called at these time points to obtain a history of any further feeding difficulties.
67 studies on the registry are indexed under Infant Nutrition Disorders; 14 are open to participants now.
This study's planned enrollment of 40 is below the median of 180 across 46 interventional studies indexed under Infant Nutrition Disorders.
Browse Infant Nutrition Disorders studies →Nemours Children's Clinic is the lead sponsor of 130 studies on the registry; 26 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
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
Other: Dietary intervention
The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period
Other: Dietary intervention
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Time from study entry to independent oral feeding
full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days
Time frame: Before or at NICU-discharge
oral feeding volume at NICU discharge
oral feeding volume (mL/kg/day) at discharge
Time frame: before 3 months
NICU Feeding related length of stay (LOS)
Days from first oral feeding to independent oral feeding
Time frame: before 3 months
Gastrostomy rates
Percentage of infants with gastrostomy placement
Time frame: through study completion, an average of 1 year
ARH levels
Directional changes in ARH pre-post intervention
Time frame: 2 weeks
Oral feeding success rate
Independent oral feeding at NICU discharge
Time frame: Before 3 months
Body composition change in FM and FFM
Directional changes in FM and FFM pre-post intervention
Time frame: 2 weeks
Plan to share: Yes — Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data requests can be submitted starting 9 months after article publication
Access criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Jul 2027, 34 months after the start.
Of 25 interventional studies with no phase under Infant Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 27. This study's planned 34 months is above that.
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