NCT02470104|Completed
Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
Sponsor study identifier
interventional
42
1 country
1
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 25, 2017
Actual (reported)Study Completion
May 4, 2018
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.
May 4, 2018
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.
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
April 1, 2015
Actual (reported)June 12, 2015
Actual (reported)May 25, 2017
Actual (reported)May 4, 2018
Actual (reported)Percentage of lactobacillales
Bar chart to indicate percentage of lactobacillales in stool samples.
21 days after transplant
Pro-inflammatory cytokine level
weekly during study course; up to approximately one year
Incidence of bacteremia
though day 14 post transplant
Incidence of graft versus host disease (GVHD)
through study course; approximately one year
* Donor 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.
• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.
* A registered dietician will supervise milk provision. * 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, MB.BS, PhD, MRCP
Children's Hospital Medical Center, Cincinnati
42 participants (actual enrollment reported by the registry).
First Submitted
April 1, 2015
First Posted
June 12, 2015
Study Start
March 2015
Date type not reportedThis date has not been verified as actual or estimated.
Effectiveness of Oral Immunotherapy Among Preterm Babies
Primary Completion
May 25, 2017
Actual (reported)Study Completion
May 4, 2018
Actual (reported)Last Updated
August 20, 2020
Record last verified: 2020-08
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Source: ClinicalTrials.gov.
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