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

Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

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.

Study Overview

• Status: Completed
• Conditions: Neurodevelopmental Outcomes of VLBW Infants
• Intervention / Treatment: Dietary supplement: Donor Human Milk

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• <1501 g weight at birth

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Dietary supplement: Donor Human Milk; Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
Experimental: 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	Dietary supplement: Donor Human Milk; Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tarah T Colaizy
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Tarah T Colaizy, MD, MPH, University of Iowa

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Actual): August 4, 2017
• Last Update Submitted That Met QC Criteria: August 3, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Breastfeeding; Preterm infant; Human Milk; BSID III; Donor Human Milk
• Other Study ID Numbers: 200708746; K23HD057232 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Contact PI to discuss data sharing