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

Tarah T Colaizy

Status: Completed

Conditions: Neurodevelopmental Outcomes of VLBW Infants

Treatments: Dietary Supplement: Donor Human Milk

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01232725

K23HD057232 (U.S. NIH Grant/Contract)

200708746

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <1501 g weight at birth

Exclusion criteria

• chromosomal anomalies
• congenital heart disease
• congenital disorders known to impair neurodevelopment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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121 participants in 2 patient groups

Donor Human Milk

Experimental group

Description:

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

Treatment:

Dietary Supplement: Donor Human Milk

Preterm Formula

Experimental group

Description:

VLBW infants randomized to receive preterm infant formula for any feedings for which maternal milk is unavailable, including infants receiving no maternal milk

Treatment:

Dietary Supplement: Donor Human Milk