Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04325308
Recruitment Status : Recruiting
First Posted : March 27, 2020
Last Update Posted : May 24, 2022
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Ariel A. Salas, University of Alabama at Birmingham

Brief Summary:
The central hypothesis of this clinical trial is that, in extremely preterm infants, protein-enriched human milk diets compared to usual human milk diets during the first 2 weeks after birth increase fat-free mass (FFM)-for-age Z scores and promote maturation of the gut microbiome at term corrected age.

Condition or disease Intervention/treatment Phase
Prematurity; Extreme Feeding Disorder Neonatal Breast Milk Expression Growth Failure Microbial Colonization Procedure: Protein-enriched human milk diet Procedure: Usual human milk diet Not Applicable

Detailed Description:
Masked randomized clinical trial in which extremely preterm infants fed human milk will be randomly assigned to receive either a protein-enriched diet (intervention group) or a usual diet (control group) within the first 96 hours after birth.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Caregivers and primary outcome evaluators will be masked. Nutrition room staff not involved in patient care will be responsible for determining participant allocation to one of the supplementation groups by opening sequentially numbered sealed envelopes, dispensing feeding syringes with the allocated human milk diet (protein-enriched or usual), and masking caregivers administering the assigned dietary intervention.
Primary Purpose: Prevention
Official Title: Early Life Protein-enriched Human Milk Diets to Increase Lean Body Mass Accretion and Diversity of the Gut Microbiome in Extremely Preterm Infants: a Randomized Trial
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : September 30, 2023

Arm Intervention/treatment
Experimental: Protein-enriched human milk diet
Infants in this group will receive protein-enriched expressed human milk or donor human milk during the first 2 weeks after birth.
Procedure: Protein-enriched human milk diet
1.2 g of human-based protein will be added to each 100 ml of human milk administered

Active Comparator: Usual human milk diet
Infants in this group will receive either expressed human milk or donor human milk during the first 2 weeks after birth.
Procedure: Usual human milk diet
Human-based protein will not be added to the human milk administered.




Primary Outcome Measures :
  1. Fat-free mass(FFM)-for-age Z-score [ Time Frame: 36 weeks or hospital discharge ]
    FFM accretion will be estimated by air displacement plethysmography


Secondary Outcome Measures :
  1. Fat mass(FM)-for-age Z-score [ Time Frame: 36 weeks or hospital discharge ]
    FM accretion will be estimated by air displacement plethysmography

  2. Body fat(BF)-for-age Z-score [ Time Frame: 36 weeks or hospital discharge ]
    Percent BF will be estimated by air displacement plethysmography

  3. Anthropometric measurements [ Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge ]
    Weight, length, and head circumference measurements at regular intervals

  4. Growth rate [ Time Frame: Birth to 36 weeks postmenstrual age or hospital discharge ]
    Weight gain in g/kg/day

  5. Number of participants with postnatal growth failure [ Time Frame: 36 weeks or hospital discharge ]
    Diagnosis of growth failure (weight < 10th percentile)

  6. Number of participants with diagnosis of necrotizing enterocolitis [ Time Frame: Birth to 120 days or discharge, whichever occurs first ]
    Diagnosis of necrotizing enterocolitis stage 2 or 3

  7. Number of participants with diagnosis of intestinal perforation [ Time Frame: Birth to 120 days or discharge, whichever occurs first ]
    Diagnosis of intestinal perforation

  8. Death [ Time Frame: Birth to 120 days ]
    Death prior to 121 days of birth

  9. Culture-proven sepsis [ Time Frame: Birth to 120 days ]
    Diagnosis of sepsis with positive blood cultures

  10. Number of days alive and receiving full enteral feeding [ Time Frame: Birth to 28 days ]
    Total number of full enteral feeding days

  11. Number of episodes of feeding intolerance [ Time Frame: Birth to 28 days ]
    Interruption or cessation of enteral feeds for a period greater than 12 hours for abnormal abdominal examination

  12. Duration of hospital stay in days [ Time Frame: Birth to 120 days or discharge, whichever occurs first ]
    From day of admission to day of hospital discharge to home

  13. Serum creatinine [ Time Frame: Birth to 28 days ]
    Highest serum creatinine value in the first 28 days after birth


Other Outcome Measures:
  1. Changes in intestinal microbiome [ Time Frame: Birth to 36 weeks postmenstrual age ]
    Determined by molecular analyses of fecal samples

  2. Cognitive outcomes [ Time Frame: 2 years of corrected age ]
    Determined by Bayley assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 4 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age ≤ 28 weeks of gestation
  • Postnatal age < 96 hours

Exclusion Criteria:

  • Congenital malformations
  • Chromosomal anomalies
  • Terminal illness needing to limit or withhold support

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): NCT04325308


Contacts
Layout table for location contacts
Contact: Ariel Salas, MD, MSPH 205-934-4680 asalas@uabmc.edu

Locations
Layout table for location information
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Ariel Salas, MD, MSPH University of Alabama at Birmingham
Layout table for additonal information
Responsible Party: Ariel A. Salas, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04325308    
Other Study ID Numbers: 300005089
K23HD102554 ( U.S. NIH Grant/Contract )
First Posted: March 27, 2020    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Communicable Diseases
Infections
Failure to Thrive
Feeding and Eating Disorders
Disease Attributes
Pathologic Processes
Mental Disorders