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Completed

NCT Number: NCT01232725

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

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.

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Key information

Conditions

Neurodevelopmental Outcomes of VLBW Infants Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <1501 g weight at birth

Exclusion criteria

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

Treatment and study plan

Donor Human Milk

Dietary Supplement

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

Primary outcomes

  1. Cognitive scale score of the Bayley Scales of Infant Development, III

    Time frame: 18 - 22 months' adjusted age

    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

Secondary outcomes

  1. Late Onset sepsis

    Time frame: 4 months

    We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula

  2. length of hospital stay

    Time frame: 4 months

    We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula

Sponsors and collaborators

Lead sponsor

Tarah T Colaizy

Other

Collaborators

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

Registry information

Official study title

Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding

Important dates

Study start
2009
Primary completion
2014
Study completion
2016
First posted
Nov 2, 2010
Registry last updated
Aug 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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