Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes (Rx 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02221167
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
Children's Miracle Network
The Gerber Foundation
Information provided by (Responsible Party):
Laura Kair, University of Iowa

Brief Summary:

This study is a randomized controlled trial seeking to determine whether supplementing infants at risk for excessive neonatal weight loss with a small volume of human donor milk prophylactically in the first 1-3 days of life, before maternal mature milk production (before mom's milk "comes in") will decrease the incidence of formula use at 1 week and 1, 2, and 3 months of life and increase the rate of exclusive breastfeeding in this high-risk population.

We hypothesize that supplementation of term infants who have lost greater than or equal to 5% birth weight by 36 hours of age with a small volume of donor breast milk following feeds, until mature milk production, will result in decreased supplemental formula use at 1 week and increased exclusive as well as any breastfeeding at 1 week and 1, 2, and 3 months. This study's specific aims are to compare the effectiveness of encouraging in-hospital exclusive breastfeeding with offering early small-volume donor milk supplementation in a population of infants at risk for excessive neonatal weight loss with goals of 1) decreasing the incidence of formula supplementation at 1 week of life and 2) improving breastfeeding duration.


Condition or disease Intervention/treatment Phase
Breastfeeding Duration Exclusive Breastfeeding Donor Milk Supplementation Other: Donor Milk Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arm Intervention/treatment
No Intervention: Exclusive breastfeeding
Infants in the exclusive breastfeeding group will continue to breastfeed.
Active Comparator: Donor Milk
Infants in this arm will continue to breastfeed and will be given 10 ml of donor breast milk by syringe after each breastfeeding until their mother's milk "comes in." (until the onset of lactogenesis II)
Other: Donor Milk
breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."
Other Names:
  • donor breast milk
  • human donor milk




Primary Outcome Measures :
  1. Any formula use at 1 week of age [ Time Frame: 1 week ]
    Any formula intake within the last 24 hours.


Secondary Outcome Measures :
  1. Exclusive breastfeeding [ Time Frame: 3 months ]
    Infants receiving breast milk and no formula in the last 24 hours.

  2. Any breastfeeding at 3 months [ Time Frame: 3 months ]
    Infants receiving some breast milk in addition to some formula in the last 24 hours.

  3. Any breastfeeding [ Time Frame: 1 month ]
  4. Exclusive breastfeeding [ Time Frame: 1 month ]
  5. Exclusive breastfeeding [ Time Frame: 2 months ]
  6. Any breastfeeding [ Time Frame: 2 months ]
  7. Any breastfeeding [ Time Frame: 1 week ]


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 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gestational age greater than or equal to 37 weeks
  • Weight loss greater than or equal to 5% (rounded to nearest whole percent) of birth weight in the first 36 hours after birth
  • Chronologic age of 24-48 hours old at the time of study enrollment

Exclusion Criteria:

  • twins and higher level multiples
  • infant has congenital or chromosomal anomalies that may affect feeding, diagnosed prior to study enrollment
  • mother incarcerated
  • mother's age <18 years
  • mother reports mature milk production prior to study enrollment
  • mother does not speak English
  • infants offered > 1 supplemental feeding of formula or donor milk
  • weight loss greater than 10%

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): NCT02221167


Locations
Layout table for location information
United States, Iowa
University of Iowa Children's Hospital
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Laura Kair
Children's Miracle Network
The Gerber Foundation
Investigators
Layout table for investigator information
Principal Investigator: Laura R Kair, MD University of Iowa
Study Director: Tarah T Colaizy, MD, MPH University of Iowa
Study Director: Valerie J Flaherman, MD, MPH University of California, San Francisco
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Laura Kair, Adjunct Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT02221167    
Other Study ID Numbers: 201406730
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Keywords provided by Laura Kair, University of Iowa:
breastfeeding
donor milk
formula
exclusive breastfeeding
newborn