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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04599010
Study type	Interventional
Source	Nemours Children's Clinic
Contact	Sreekanth Viswanathan, MD,MS
Phone	4076977603
Email	sreekanth.viswanathan@nemours.org
Status	Not yet recruiting
Phase	N/A
Start date	July 15, 2024
Completion date	June 1, 2026

View Details

See also
Status	Clinical Trial	Phase
Enrolling by invitation	`NCT05515835` - Relationship Between Effect Duration of Rocuronium and Body Composition Analysis Data.
Enrolling by invitation	`NCT05512559` - Body Composition Analysis and Time to Emergence From Remimazolam
Completed	`NCT04136821` - The Long-term Effects of Oceanix™ on Resistance Training Adaptations	N/A
Completed	`NCT03432130` - Injury Occurrence in Hip-hop Dance	N/A
Completed	`NCT04504799` - Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse
Withdrawn	`NCT04021446` - A Supervised Clinic-to-Community Exercise Intervention to Improve Cardiometabolic Health in Survivors of AYA Cancer	N/A
Completed	`NCT02211612` - Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation	N/A
Completed	`NCT03412578` - Effect of Tactile/Kinaesthetic Massage Therapy on DXA Parameter of Preterm Infants	N/A
Completed	`NCT02000492` - Frequent Ballgames Training for 9-11 Year Old Schoolchildren	N/A
Completed	`NCT01209936` - Hydration Factor Study for the Stayhealthy BC3	N/A
Recruiting	`NCT06061315` - Effect of Collagen Peptides, in Combination With Resistance Training, on Body Composition and Muscle Strength in Untrained Men	N/A
Completed	`NCT05730660` - Quercetin Phytosome® Chronic Fatigue Syndrome	N/A
Recruiting	`NCT04969588` - Kinect Equations for Body Indices and Body Composition
Completed	`NCT04828655` - Analysis of Bioparametric Measures for Correlating Daily Habits and Reducing Blood Pressure	N/A
Completed	`NCT04404413` - High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women	N/A
Completed	`NCT05052164` - Improvement Of Physical And Physiological Parameters In Menopausal Or Post-Menopausal Celiac Women	N/A
Completed	`NCT03352583` - Effects of Casein Timing on Body Composition and Performance	N/A
Enrolling by invitation	`NCT03587233` - Are Women With Higher Professional Status More Sedentary Compared to Men?	N/A
Recruiting	`NCT05556239` - STAY-STRONG Study of Exercise Training During Chemotherapy	N/A
Active, not recruiting	`NCT04306523` - Early Genetic and Environmental Influences on Eating - The Baylor Infant Twins Study

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms