Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
This study has been completed.
Sponsor:
University of Iowa
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Tarah T Colaizy, University of Iowa
ClinicalTrials.gov Identifier:
NCT01232725
First received: October 29, 2010
Last updated: May 26, 2016
Last verified: May 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neurodevelopmental Outcomes of VLBW Infants |
Dietary Supplement: Donor Human Milk |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding |
Resource links provided by NLM:
Further study details as provided by University of Iowa:
Primary Outcome Measures:
- Cognitive scale score of the Bayley Scales of Infant Development, III [ Time Frame: 18 - 22 months' adjusted age ] [ Designated as safety issue: No ]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 Outcome Measures:
- Late Onset sepsis [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]We will compare rates of in-hospital confirmed late onset sepsis in VLBW infants receiving donor human milk and preterm formula
- length of hospital stay [ Time Frame: 4 months ] [ Designated as safety issue: No ]We will compare the length of initial hospital stay between infants who receive donor human milk and those who receive preterm infant formula
| Enrollment: | 121 |
| Study Start Date: | August 2009 |
| Study Completion Date: | May 2016 |
| Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | up to 24 Months (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- <1501 g weight at birth
Exclusion Criteria:
- chromosomal anomalies
- congenital heart disease
- congenital disorders known to impair neurodevelopment
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232725
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232725
Locations
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
Sponsors and Collaborators
University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Tarah T Colaizy, MD, MPH | University of Iowa |
More Information
| Responsible Party: | Tarah T Colaizy, Associate Professor of Pediatrics, University of Iowa |
| ClinicalTrials.gov Identifier: | NCT01232725 History of Changes |
| Other Study ID Numbers: | 200708746 K23HD057232 |
| Study First Received: | October 29, 2010 |
| Last Updated: | May 26, 2016 |
| Health Authority: | United States: Federal Government |
| Individual Participant Data | |
| Plan to Share IPD: | Yes |
| Plan Description: | Contact PI to discuss data sharing |
Keywords provided by University of Iowa:
|
BSID III Human Milk Donor Human Milk Preterm infant Breastfeeding |
ClinicalTrials.gov processed this record on September 23, 2016