Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-05-04

Brief Summary

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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.

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Detailed Description

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The investigators hypothesize that the gut microbiota during bone marrow transplant could be influenced by administration of enteral donor breast milk. This study will attempt to address this hypothesis, by feeding donor breast milk to young children undergoing transplant, and serially comparing the gut microbiota in children receiving human milk, with those receiving conventional feeding.

Conditions

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Bone Marrow Transplant - Autologous or Allogeneic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Enteral Donor Breastmilk

* 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.

Group Type EXPERIMENTAL

Breastmilk

Intervention Type DIETARY_SUPPLEMENT

* 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.

Control

• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Breastmilk

* 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.

Intervention Type DIETARY_SUPPLEMENT