Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Primary Purpose
Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Body Composition
Eligibility Criteria
Inclusion Criteria:
- LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score > +1.0 in body composition measurement
Exclusion Criteria:
- Infants on any respiratory support, Infants on enteral feeding duration > 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes/anomalies
Sites / Locations
- Nemours Children's Hospital
- Cincinnati Children's Hospital Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
FFM-indexed feeding
Standard feeding
Arm Description
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
The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period
Outcomes
Primary Outcome Measures
Time from study entry to independent oral feeding
full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days
Secondary Outcome Measures
oral feeding volume at NICU discharge
oral feeding volume (mL/kg/day) at discharge
NICU Feeding related length of stay (LOS)
Days from first oral feeding to independent oral feeding
Gastrostomy rates
Percentage of infants with gastrostomy placement
ARH levels
Directional changes in ARH pre-post intervention
Oral feeding success rate
Independent oral feeding at NICU discharge
Body composition change in FM and FFM
Directional changes in FM and FFM pre-post intervention
Full Information
NCT ID
NCT04599010
First Posted
October 14, 2020
Last Updated
October 16, 2023
Sponsor
Nemours Children's Clinic
Collaborators
Children's Hospital Medical Center, Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT04599010
Brief Title
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
Official Title
Pilot Randomized Controlled Trial Comparing FFM-indexed Feeding vs. Standard Feeding in LGA Infants With Oral Feeding Difficulty and Disproportionate Body Composition.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2024 (Anticipated)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nemours Children's Clinic
Collaborators
Children's Hospital Medical Center, Cincinnati
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Body Composition, Feeding; Difficult, Newborn, Nutrition Disorder, Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The sample size for this pilot study will be 40 with 20 infants randomized into each arm.
Masking
Outcomes Assessor
Masking Description
The data analyzer will be masked to the allocation
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FFM-indexed feeding
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard feeding
Arm Type
Active Comparator
Arm Description
The standard feeding approach will include an oral feeding volume goal of 150 ± 10 mL/kg/day during the 2-week study period
Intervention Type
Other
Intervention Name(s)
Dietary intervention
Intervention Description
energy-restricted diet appropriate for resting metabolic rate using FFM as proxy
Primary Outcome Measure Information:
Title
Time from study entry to independent oral feeding
Description
full oral feeding defined as 120 ml/kg/d without tube feeding for 2 consecutive days
Time Frame
Before or at NICU-discharge
Secondary Outcome Measure Information:
Title
oral feeding volume at NICU discharge
Description
oral feeding volume (mL/kg/day) at discharge
Time Frame
before 3 months
Title
NICU Feeding related length of stay (LOS)
Description
Days from first oral feeding to independent oral feeding
Time Frame
before 3 months
Title
Gastrostomy rates
Description
Percentage of infants with gastrostomy placement
Time Frame
through study completion, an average of 1 year
Title
ARH levels
Description
Directional changes in ARH pre-post intervention
Time Frame
2 weeks
Title
Oral feeding success rate
Description
Independent oral feeding at NICU discharge
Time Frame
Before 3 months
Title
Body composition change in FM and FFM
Description
Directional changes in FM and FFM pre-post intervention
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
10 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
LGA infants with oral feeding difficulty born at ≥ 35 weeks gestation, with FM z-score > +1.0 in body composition measurement
Exclusion Criteria:
Infants on any respiratory support, Infants on enteral feeding duration > 60 minutes due to hypoglycemia concerns, videofluoroscopic swallow study (VFSS) demonstrating unsafe swallowing function, GI surgical conditions, significant neurological morbidities, and major congenital, genetic syndromes/anomalies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sreekanth K Viswanathan, MD,MS
Phone
4076977603
Email
sreekanth.viswanathan@nemours.org
Facility Information:
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sreekanth K Viswanathan
Phone
407-697-7603
Email
sreekanth.viswanathan@nemours.org
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kera McNelis, MD
Email
kera.mcnelis@cchmc.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
Once study started enrolling
Learn more about this trial
Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
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