Trial | NCT02025478  Report issue

Title

Human Breastmilk in Children Receiving a Bone Marrow Transplant
A Pilot Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    human milk ...

  • Study Participants

    11
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.
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 micobiota in children receiving human milk, with those receiving conventional feeding.
Study Started
May 31
2013
Primary Completion
Oct 31
2013
Study Completion
Jan 31
2014
Last Update
Aug 20
2020

Dietary Supplement Breastmilk

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.

Enteral Donor Breastmilk Experimental

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.

Criteria 

Inclusion Criteria:

Children less than 5 years old receiving transplant (autologous or allogeneic)
Parents must give informed consent

Exclusion Criteria:

- Failure to meet inclusion criteria
No Results Posted