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Donor Breast Milk and Breastfeeding Rates

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: NCT04572581
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Kara L. Calkins, MD, University of California, Los Angeles

Brief Summary:
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Condition or disease Intervention/treatment Phase
Breastfeeding, Exclusive Breastfeeding Other: Donor Breast Milk Not Applicable

Detailed Description:
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : August 15, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exclusively Human Milk Diet
This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation.
Other: Donor Breast Milk
Donor breast milk will be given to the newborn if supplementation is required

No Intervention: Formula-based Diet
If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care).



Primary Outcome Measures :
  1. Study Feasibility_1 [ Time Frame: 6-8 weeks chronological age ]
    Feasibility will be evaluated by: consent rate

  2. Study Feasibility_2 [ Time Frame: 6-8 weeks chronological age ]
    Feasibility will be evaluated by: study completion rate

  3. Study Feasibility_3 [ Time Frame: 6-8 weeks chronological age ]
    Feasibility will be evaluated by: rate of adherence to the study diet.


Secondary Outcome Measures :
  1. Percentage of Human Milk Consumption at Discharge [ Time Frame: at the time of NICU discharge or 7 days of age, whichever is later ]
    Maternal milk/total milk (percent) consumed by the neonate over 48 hours

  2. Percentage of Human Milk Consumption After Discharge [ Time Frame: 6-8 weeks chronological age ]
    Maternal milk/total milk (percent) consumed by the infant over 48 hours

  3. Breastfeeding duration [ Time Frame: 6-8 weeks chronological age ]
    time infant received breastmilk since birth

  4. Intent to Breastfeed [ Time Frame: 6-8 weeks chronological age ]
    Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no.

  5. Growth: Weight [ Time Frame: 6-8 weeks chronological age ]
    Weight in kilograms reported as a z-score

  6. Growth: Height [ Time Frame: 6-8 weeks chronological age ]
    height in centimeters reported as a z-score

  7. Growth: Head Circumference [ Time Frame: 6-8 weeks chronological age ]
    head circumference in centimeters reported as a z-score


Other Outcome Measures:
  1. Intestinal Microbiome: microbial profiling (genus level) [ Time Frame: 7 days of age ]
    Microbial profiling (genus level) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene

  2. Intestinal Microbiome: alpha diversity (Chao1) [ Time Frame: 7 days of age ]
    Alpha diversity (Chao1) will be investigated by sequencing of the V4 region of the 16S ribosomal ribonucleic acid gene



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age >34 weeks and 0 days
  • Mother's intent to breast feed
  • NICU admission which is predicted to be at least 72 hours from time of admission

Exclusion Criteria:

  • Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
  • Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
  • Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
  • Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation or nasal intermittent mechanical ventilation) and/or ionotropic medications
  • Any infant whose care is considered futile by the primary medical team

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): NCT04572581


Contacts
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Contact: Neema K Pithia, MD (310) 825-9111 ext 33559 npithia@mednet.ucla.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90025
Contact: Neema K Pithia, MD    310-825-9111 ext 33559    npithia@mednet.ucla.edu   
Santa Monica-UCLA Recruiting
Los Angeles, California, United States, 90404
Contact: Neema K Pithia, MD    310-825-9111 ext 33559    npithia@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Kara L Calkins, MD University of California, Los Angeles
Publications:

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Responsible Party: Kara L. Calkins, MD, Health Sciences Clinical Assistant Professor, Pediatric Neonatology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04572581    
Other Study ID Numbers: 19-002179
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no current plan to make IPD available for other research given this is a small pilot feasibility study.

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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 Kara L. Calkins, MD, University of California, Los Angeles:
Late Preterm
Donor Breast Milk