NCT01232725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

October 29, 2010

Last Update Submit

August 3, 2017

Conditions

Neurodevelopmental Outcomes of VLBW Infants

Keywords

BSID IIIHuman MilkDonor Human MilkPreterm infantBreastfeeding

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Late Onset sepsis

    4 months

  • length of hospital stay

    4 months

Study Arms (2)

Donor Human Milk

EXPERIMENTAL

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

Preterm Formula

EXPERIMENTAL

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

Interventions

Donor Human MilkDIETARY_SUPPLEMENT

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

Donor Human MilkPreterm Formula

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \<1501 g weight at birth

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (1)

  • 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.

    PMID: 39239939DERIVED

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Officials

  • Tarah T Colaizy, MD, MPH

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 2, 2010

Study Start

August 1, 2009

Primary Completion

December 1, 2014

Study Completion

May 1, 2016

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will share

Contact PI to discuss data sharing

Locations

US(1)