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Effect of Protein Intake on Preterm Infant Body Composition

Effect of Protein Intake on Preterm Infant Body Composition

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02353013
Enrollment
36
Registered
2015-02-02
Start date
2014-12-31
Completion date
2017-10-01
Last updated
2017-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature; Infant, Light-for-dates

Keywords

protein intake, body composition

Brief summary

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

Detailed description

American Academy of Pediatrics guidelines define the growth rate of preterm, underweight babies as adequate if it matches the age-equivalent weight gains typical of term infants, approximately 10-15 grams per kg per day. Unfortunately, many pre-terms, especially very low birth weight ones, do not achieve this rate, resulting in neurodevelopmental deficits and low discharge weights. Typical feeding regimens, designed to increase weight gain, however, have been shown to increase the rate of fat accretion and increase the risk of obesity and metabolic disorders, such as insulin resistance and type 2 diabetes, later in life. Research has shown that higher protein diets can reduce the accretion of body fat in older, normal weight infants but this has not been systematically tested in low birth weight pre-terms. The current study will compare weight gain based on fat accretion and change in body composition in preterm infants receiving higher (4g/100 kcal) versus lower (3 g/100 kcal) protein-energy ratio diets. The hypothesis tested in this study is: Increased protein intake will reduce the percentage of weight gain due to fat accretion in pre-term infants. The identification of an effective feeding regimen that would both allow pre-term infants to acquire age-equivalent growth rates similar to those of term infants while avoiding the excess accretion of body fat could significantly improve the long term health outcomes of this high-risk population.

Interventions

DIETARY_SUPPLEMENTProtein supplementation

Standard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed.

DIETARY_SUPPLEMENTStandard fortification

Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Years
Healthy volunteers
No

Inclusion criteria

* Premature infants born less than 32 weeks EGA * Growth that is appropriate for gestational age (AGA) * Admitted to OU Children's NICU, inborn or outborn * Receiving enteral feedings \<100 mL/kg/day * Hemodynamically stable

Exclusion criteria

* Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings * Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA) * Inborn errors of metabolism * History of necrotizing enterocolitis Bell stage III * Cerebrospinal fluid indwelling shunt (affects body composition measurements) * Expected death prior to 36 weeks EGA (the end of the study period) * Inability to meet Pea Pod® requirements for the first measurement * On vasopressor medications

Design outcomes

Primary

MeasureTime frame
Weight gain due to fat mass4 weeks

Secondary

MeasureTime frame
Change in body weight4 weeks
Change in percent fat mass4 weeks
Change in length4 weeks
Change in head circumference4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026