Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants

Study Overview
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Brief Summary
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Breastfeeding is an important health-promoting behavior. Human milk is the ideal diet for all infants, optimizes intellect, and provides protection against infectious and atopic diseases in childhood as well as decreasing risks for obesity, hypertension and other chronic diseases. Infants with the highest risk of life-long disability, very low birthweight (VLBW) preterm infants, are breastfed at some of the lowest rates in the US. Maternal milk is not always available, and pasteurized donor human milk is an alternative that requires investigation. Whether donor milk conveys health and developmental advantages similar to those bestowed by maternal milk is unknown. By determining the effects of donor milk on health and developmental outcomes when compared to preterm infant formula, the investigators seek to optimize outcomes in this fragile population. The hypothesis of our donor milk research is that a donor human milk diet in non-maternal milk fed VLBW infants is associated with better neurodevelopmental outcome scores at 18-22 months adjusted age than a preterm infant formula diet.

Official Title
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Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Conditions
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Neurodevelopmental Outcomes of VLBW Infants

Intervention / Treatment
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* Dietary Supplement: Donor Human Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <1501 g weight at birth Exclusion Criteria: chromosomal anomalies congenital heart disease congenital disorders known to impair neurodevelopment

Ages Eligible for Study
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Maximum Age: 24 Months

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Donor Human Milk<br>VLBW infants randomized to be fed donor human milk, fortified as appropriate, for all feedings for which maternal milk is not available, including infants who receive no maternal milk | Dietary Supplement: Donor Human Milk<br>* Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank<br>|
| Experimental: Preterm Formula<br>VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk | Dietary Supplement: Donor Human Milk<br>* Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive scale score of the Bayley Scales of Infant Development, III | We will administer the BSID III to all subjects at 18-22 mo of age, adjusted for prematurity. We will compare the scores between subjects who received donor human milk to those who received preterm infant formula | 18 - 22 months' adjusted age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Onset sepsis | We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula | 4 months | 
| length of hospital stay | We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BSID III, Human Milk, Donor Human Milk, Preterm infant, Breastfeeding