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Effect of Increased Enteral Protein on Body Composition of Preterm Infants

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ClinicalTrials.gov Identifier: NCT03586102
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
Children's Health System, Alabama
Information provided by (Responsible Party):
Ariel A. Salas, MD, University of Alabama at Birmingham

Brief Summary:
The study hypothesis is that, in human milk-fed extremely preterm infants, higher protein intake compared to usual protein intake reduces percent body fat (%BF) at 3 months of age.

Condition or disease Intervention/treatment Phase
Premature Infant Dietary Supplement: High protein supplementation Dietary Supplement: Standard protein supplementation Not Applicable

Detailed Description:

Qualifying participants will be randomly assigned to receive either standard protein supplementation (control group) or high protein supplementation (intervention group).

Intervention group: A fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk after establishment of full enteral feeding.

Control group: Hydrolyzed bovine protein will not be added to fortified human milk after establishment of full enteral feeding.

If parent agrees, stool "dirty" diapers will be collected 2 times (at the time of hospital discharge and at 3 months of corrected age).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Clinicians and technicians responsible for the assessment of infant body composition will be masked.
Primary Purpose: Prevention
Official Title: Effect of Increased Enteral Protein on Body Composition of Preterm Infants: A Randomized Trial
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: High protein supplementation
Infants will receive a diet that consists of mother's own milk or donor human milk and bovine-based human milk fortifier plus a fixed amount of commercially available hydrolyzed bovine protein. The study intervention will begin the day after fortification is ordered and will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.
Dietary Supplement: High protein supplementation
To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.

Active Comparator: Standard protein supplementation
Infants will receive a standard diet that consists of mother's own milk or donor human milk (DHM) and bovine-based human milk fortifier. The study intervention will be continued until postnatal day 50 or 32 weeks postmenstrual age, whichever occurs first.
Dietary Supplement: Standard protein supplementation
Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)




Primary Outcome Measures :
  1. Infant body composition [ Time Frame: Assessed at 3 months of corrected age ]
    Percent body fat estimated by air displacement plethysmography


Secondary Outcome Measures :
  1. Infant body composition [ Time Frame: Assessed at 36 weeks of postmenstrual age or hospital discharge (whichever occurs first) ]
    Percent body fat estimated by air displacement plethysmography

  2. Growth [ Time Frame: Birth to 3 months of corrected age ]
    Weekly weight gain in grams

  3. Length [ Time Frame: Birth to 3 months of corrected age ]
    Weekly length in cm

  4. Head circumference [ Time Frame: Birth to 3 months of corrected age ]
    Weekly head circumference in cm

  5. Body mass index [ Time Frame: Birth to 3 months of corrected age ]
    Weight and height will be combined to report BMI in kg/m^2

  6. Necrotizing enterocolitis [ Time Frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first ]
    Number of participants with diagnosis of necrotizing enterocolitis stage 2 or 3

  7. Death [ Time Frame: Postnatal day 14 to postnatal day 120 or discharge, whichever occurs first ]

Other Outcome Measures:
  1. Changes in intestinal microbiome [ Time Frame: Birth to 3 months of corrected age ]
    Determined by molecular analyses of bacteria in fecal samples

  2. Changes in metabolic pathways [ Time Frame: Birth to 3 months of corrected age ]
    Determined by molecular analyses of serum samples



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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age between 25 and 28 weeks of gestation
  • Feeding volumes of ≥120 ml/kg/day before or on postnatal day 14.

Exclusion Criteria:

  • Necrotizing enterocolitis (NEC) stage 2 or greater.
  • Gastrointestinal or neurologic malformations.
  • Terminal illness needing to limit or withhold support will be exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03586102


Contacts
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Contact: Ariel A. Salas, MD, MSPH 205-934-4680 asalas@peds.uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ariel A. Salas, MD, MSPH         
Sponsors and Collaborators
University of Alabama at Birmingham
Children's Health System, Alabama
Investigators
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Principal Investigator: Ariel A. Salas, MD, MSPH University of Alabama at Birmingham

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Responsible Party: Ariel A. Salas, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03586102     History of Changes
Other Study ID Numbers: 300000681
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ariel A. Salas, MD, University of Alabama at Birmingham:
Protein supplementation
Human milk fortification