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

NCT ID: NCT01232725

Last Updated: 2017-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2016-05-31

Brief Summary

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.

Conditions

Neurodevelopmental Outcomes of VLBW Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Donor Human Milk

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

Group Type: EXPERIMENTAL

Donor Human Milk

Intervention Type: DIETARY_SUPPLEMENT

Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank

Preterm Formula

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

Group Type: EXPERIMENTAL

Donor Human Milk

Intervention Type: DIETARY_SUPPLEMENT

Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank

Interventions

Donor Human Milk

Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• <1501 g weight at birth

Exclusion Criteria

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

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Tarah T Colaizy

OTHER

Sponsor Role: lead

Responsible Party

Tarah T Colaizy

Associate Professor of Pediatrics

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tarah T Colaizy, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

Quigley M, Embleton ND, Meader N, McGuire W. Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024 Sep 6;9(9):CD002971. doi: 10.1002/14651858.CD002971.pub6.

Reference Type: DERIVED

PMID: 39239939 (View on PubMed)

Other Identifiers

K23HD057232

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200708746

Identifier Type: -

Identifier Source: org_study_id