Human Breastmilk in Children Receiving a Bone Marrow Transplant

NCT02025478 | Completed

• 1 other identifier: 2013-2412
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 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.

Conditions

Bone Marrow Transplant- Autologous or Allogeneic

Keywords

children; bone marrow transplant; autologous; allogeneic; breastmilk; hematopoietic stem cell transplantation (HSCT)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (1)

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.

Dietary Supplement: Breastmilk

Interventions

Breastmilk DIETARY_SUPPLEMENT

* 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

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Mothers' Milk Bank Northeast: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Study Officials

• Stella Davies, MBBS, PhD, MRCP

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: January 1, 2014
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: January 1, 2014
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

US (1)