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Breastfeeding DurationRx MilkNCT02221167

Rx Milk Study of Donor Milk Supplementation to Improve Breastfeeding Outcomes

A study testing Donor Milk in people with Breastfeeding Duration and Exclusive Breastfeeding, run by Laura Kair at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 24 to 48 hours
What is being tested?
Donor Milk
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
Jul 2014to Sep 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 48 hours
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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%

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Children's Hospital

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Rx Milk: Donor Milk Supplementation to Increase Breastfeeding Duration & Exclusivity, a Randomized Controlled Trial

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.

Being tested
Donor Milk
Keywords
breastfeeding, donor milk, formula, exclusive breastfeeding, newborn
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Donor MilkOther

    Also called donor breast milk, human donor milk

    breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk "comes in."

Study groups in NCT02221167
Study groupRoleWhat they receive
Exclusive breastfeedingNo interventionInfants in the exclusive breastfeeding group will continue to breastfeed.
Donor MilkActive comparatorInfants 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)
Receives: Other: Donor Milk

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Any formula use at 1 week of age

    Any formula intake within the last 24 hours.

    Measured: 1 week

Secondary outcomes (7)

  1. Exclusive breastfeeding

    Infants receiving breast milk and no formula in the last 24 hours.

    Measured: 3 months

  2. Any breastfeeding at 3 months

    Infants receiving some breast milk in addition to some formula in the last 24 hours.

    Measured: 3 months

  3. Any breastfeeding

    Measured: 1 month

  4. Exclusive breastfeeding

    Measured: 1 month

  5. Exclusive breastfeeding

    Measured: 2 months

  6. Any breastfeeding

    Measured: 2 months

  7. Any breastfeeding

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02221167
Sponsor's protocol ID
201406730
Acronym
Rx Milk
Status last verified
Mar 2018
First submitted
18 Aug 2014
Last updated
16 Mar 2018
Results posted
No
Data monitoring committee
No

Publications

  • Flaherman VJ, Aby J, Burgos AE, Lee KA, Cabana MD, Newman TB. Effect of early limited formula on duration and exclusivity of breastfeeding in at-risk infants: an RCT. Pediatrics. 2013 Jun;131(6):1059-65. doi: 10.1542/peds.2012-2809. Epub 2013 May 13.

    PubMed 23669513

  • Flaherman VJ, Kuzniewicz MW, Li S, Walsh E, McCulloch CE, Newman TB. First-day weight loss predicts eventual weight nadir for breastfeeding newborns. Arch Dis Child Fetal Neonatal Ed. 2013 Nov;98(6):F488-92. doi: 10.1136/archdischild-2012-303076. Epub 2013 Jul 17.

    PubMed 23864443

  • Flaherman VJ, Bokser S, Newman TB. First-day newborn weight loss predicts in-hospital weight nadir for breastfeeding infants. Breastfeed Med. 2010 Aug;5(4):165-8. doi: 10.1089/bfm.2009.0047.

    PubMed 20113202

  • Kair LR, Flaherman VJ, Colaizy TT. Effect of Donor Milk Supplementation on Breastfeeding Outcomes in Term Newborns: A Randomized Controlled Trial. Clin Pediatr (Phila). 2019 May;58(5):534-540. doi: 10.1177/0009922819826105. Epub 2019 Jan 28.

    PubMed 30688082

Questions about this trial

What is this clinical trial studying?

A study testing Donor Milk in people with Breastfeeding Duration and Exclusive Breastfeeding, run by Laura Kair at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any formula use at 1 week of age (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02221167, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.

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