- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02353013
Effect of Protein Intake on Preterm Infant Body Composition
December 20, 2017 updated by: Courtney B. Atchley, DO, University of Oklahoma
The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73117
- OUHSC Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 minute to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Protein Group
For infants in this group, the target protein-energy ratio (PER) will be ~3 g/100 kcal.
This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula.
|
Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.
|
Experimental: Enhanced Protein Group
For infants in this group, the target protein-energy ratio (PER) will be ~4 g/100 kcal.
This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula.
In addition, liquid protein will be added to provide protein supplementation and increase the PER.
|
Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Weight gain due to fat mass
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in body weight
Time Frame: 4 weeks
|
4 weeks
|
Change in percent fat mass
Time Frame: 4 weeks
|
4 weeks
|
Change in length
Time Frame: 4 weeks
|
4 weeks
|
Change in head circumference
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Courtney B Atchley, DO, OUHSC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
October 1, 2017
Study Registration Dates
First Submitted
January 28, 2015
First Submitted That Met QC Criteria
January 30, 2015
First Posted (Estimate)
February 2, 2015
Study Record Updates
Last Update Posted (Actual)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 20, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4885
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Premature; Infant, Light-for-dates
-
Meir Medical CenterUnknownFeeding Patterns | Premature; Infant, Light-for-datesIsrael
-
University of Alabama at BirminghamActive, not recruitingEnteral Feeding Intolerance | Premature; Infant, Light-for-datesUnited States
-
University of Alabama at BirminghamCompleted
-
University of Alabama at BirminghamThe Gerber FoundationActive, not recruitingPremature; Infant, Light-for-datesUnited States
-
Turku University HospitalMassachusetts General Hospital; University of TurkuUnknownBreastfeeding | Premature; Infant, Light-for-datesFinland
-
Penn State UniversityCompletedPremature; Infant, Light-for-datesUnited States
-
Ondokuz Mayıs UniversityCompletedNeurodevelopmental Disorders | Neonatal Disease | Premature; Infant, Light-for-dates | Motor DelayTurkey
-
Hospices Civils de LyonCompletedInfant; Premature, Light-For-Dates
-
International Centre for Diarrhoeal Disease Research...University of California, DavisCompletedSmall for Gestational Age at Delivery | Post-term Infant, Not Heavy-for-datesBangladesh
-
University of Alabama at BirminghamMead Johnson NutritionActive, not recruitingPrematurity | Enteral Feeding Intolerance | Light-For-DatesUnited States
Clinical Trials on Standard fortification
-
The Hospital for Sick ChildrenRecruitingVery Low Birth Weight InfantCanada
-
Centro Hospitalar de Lisboa CentralSociedade Portuguesa de NeonatologiaUnknownGrowth | Body Composition | Adiposity | Prematurity | Feeding Patterns | Nutrient Deficiency | Breast Milk CollectionPortugal
-
McMaster Children's HospitalUnknownPostnatal Growth DisorderCanada
-
Wyeth is now a wholly owned subsidiary of PfizerCompleted
-
McMaster Children's HospitalUnknownNeurodevelopment | Postnatal Growth DisorderCanada
-
Brigham and Women's HospitalRecruitingPreterm Birth | Neurodevelopmental Disorders | Breast Milk Expression | Nutrition Disorder, Infant | Brain Development AbnormalityUnited States
-
Aristotle University Of ThessalonikiCompletedMetabolic SyndromeGreece
-
University of CalgaryRecruiting
-
McMaster Children's HospitalCompletedPostnatal Growth DisorderCanada
-
Children's National Research InstituteNot yet recruitingVery Low Birth Weight Infant | Very Preterm Maturity of InfantUnited States