NCT02025478|Completed
Human Breastmilk in Children Receiving a Bone Marrow Transplant
MILK
A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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MILK
A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Sponsor study identifier
interventional
11
1 country
1
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2013
Actual (reported)Study Completion
January 2014
Actual (reported)The investigators hypothesize that children receiving human milk will maintain a greater diversity of helpful bacteria in their gut and have lower levels of inflammatory proteins in the blood compared with children not receiving human milk.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
September 5, 2013
Actual (reported)October 2013
Actual (reported)January 2014
Actual (reported)January 1, 2014
Actual (reported)Percentage of lactobacillales
Bar charts to indicate types and percentage of bacteria in stool samples - will quantify the bacterial diversity using the Shannon index and bacterial chaos using the Bray-Curtis time index.
21 days after transplant
Levels of pro-inflammatory cytokines
Weekly during study course; up to approximately one year
Incidence of bacteremia
through day 14 post transplant
Incidence of graft versus host disease (GVHD)
through study course; approximately one year
* Donor breast milk will be pasteurized prior to use. * Given orally or by nasogastric (NG) or nasojejunal (NJ) tube. * Feeding will be supervised and will be advanced as quickly as tolerated with a goal of providing 40-50% of nutritional needs from the donor milk. * It is recognized that the volume of enteral feeds will need to be adjusted per patient tolerance.
* A registered dietician will supervise milk provision, and additional calories will be provided by addition of the supplement Prolacta. To make 28 kcal/oz milk, 40 ml of Prolacta will be mixed with 60 ml human milk to make a total volume of 100 ml. * If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible, with Prolacta supplementation if clinically indicated and recommended by the registered dietician.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Stella Davies, MBBS, PhD, MRCP
Children's Hospital Medical Center, Cincinnati
11 participants (actual enrollment reported by the registry).
First Submitted
September 5, 2013
First Posted
January 1, 2014
Study Start
May 2013
Date type not reportedThis date has not been verified as actual or estimated.
Lipids and Other Bioactive Compounds of Human Breast Milk
Primary Completion
October 2013
Actual (reported)Study Completion
January 2014
Actual (reported)Last Updated
August 20, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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