Donor Human Milk in Young Children Receiving Bone Marrow Transplantation
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|ClinicalTrials.gov Identifier: NCT02470104|
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplant - Autologous or Allogeneic||Biological: Breastmilk||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Study of Enteral Donor Human Milk in Young Children Receiving Bone Marrow Transplantation|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 25, 2017|
|Actual Study Completion Date :||May 4, 2018|
Experimental: Enteral Donor Breastmilk
No Intervention: Control
• Children randomized to the control arm will receive standard enteral or parenteral nutrition per standard clinical practice, supervised by a registered dietician.
- Percentage of lactobacillales [ Time Frame: 21 days after transplant ]Bar chart to indicate percentage of lactobacillales in stool samples.
- Pro-inflammatory cytokine level [ Time Frame: weekly during study course; up to approximately one year ]Mean fold increase above baseline for the cytokine will be calculated and compared to control. Value will be tested for statistical significance using the Wilcoxon Rank Sum test.
- Incidence of bacteremia [ Time Frame: though day 14 post transplant ]Frequency of bacterial sepsis to be compared against controls.
- Incidence of graft versus host disease (GVHD) [ Time Frame: through study course; approximately one year ]Frequency of GVHD will be compared to controls.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470104
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Stella Davies, MB.BS, PhD, MRCP||Children's Hospital Medical Center, Cincinnati|