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
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2018
CompletedAugust 20, 2020
August 1, 2020
2.2 years
April 1, 2015
August 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of lactobacillales
Bar chart to indicate percentage of lactobacillales in stool samples.
21 days after transplant
Secondary Outcomes (3)
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
Study Arms (2)
Enteral Donor Breastmilk
EXPERIMENTAL* 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.
Control
NO INTERVENTION• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.
Interventions
* 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.
Eligibility Criteria
You may qualify if:
- Children less than 5 years old receiving transplant (autologous or allogeneic)
- Parents must give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Stella Davies, MB.BS, PhD, MRCP
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2015
First Posted
June 12, 2015
Study Start
March 1, 2015
Primary Completion
May 25, 2017
Study Completion
May 4, 2018
Last Updated
August 20, 2020
Record last verified: 2020-08