Donor Human Milk in Young Children Receiving Bone Marrow Transplantation

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Bone Marrow Transplant - Autologous or Allogeneic

Treatments: Dietary Supplement: Breastmilk

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02470104

2014-4127

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Enteral Donor Breastmilk

Experimental group

Description:

* 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.

Treatment:

Dietary Supplement: Breastmilk

Control

No Intervention group

Description:

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