Donor Breast Milk and Breastfeeding Rates

Study Overview
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Brief Summary
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The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.

Detailed Description
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In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.

Official Title
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Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial

Conditions
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Breastfeeding, Exclusive, Breastfeeding

Intervention / Treatment
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* Other: Donor Breast Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age >34 weeks and 0 days Mother's intent to breast feed NICU admission which is predicted to be at least 72 hours from time of admission Exclusion Criteria: Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies) Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc) Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana) Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications Any infant whose care is considered futile by the primary medical team

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exclusively Human Milk Diet<br>This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation. | Other: Donor Breast Milk<br>* Donor breast milk will be given to the newborn if supplementation is required<br>|
| No Intervention: Formula-based Diet<br>If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Feasibility_1 | Feasibility will be evaluated by: consent rate | 6-8 weeks chronological age | 
| Study Feasibility_2 | Feasibility will be evaluated by: study completion rate | 6-8 weeks chronological age | 
| Study Feasibility_3 | Feasibility will be evaluated by: rate of adherence to the study diet. | 6-8 weeks chronological age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Human Milk Consumption at Discharge | Maternal milk/total milk (percent) consumed by the neonate over 48 hours | at the time of NICU discharge or 7 days of age, whichever is later | 
| Percentage of Human Milk Consumption After Discharge | Maternal milk/total milk (percent) consumed by the infant over 48 hours | 6-8 weeks chronological age | 
| Breastfeeding duration | time infant received breastmilk since birth | 6-8 weeks chronological age | 
| Intent to Breastfeed | Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no. | 6-8 weeks chronological age | 
| Growth: Weight | Weight in kilograms reported as a z-score | 6-8 weeks chronological age | 
| Growth: Height | height in centimeters reported as a z-score | 6-8 weeks chronological age | 
| Growth: Head Circumference | head circumference in centimeters reported as a z-score | 6-8 weeks chronological age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Late Preterm, Donor Breast Milk