Donor Human Milk and Neurodevelopmental Outcomes in Very Low Birthweight (VLBW) Infants
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| ClinicalTrials.gov Identifier: NCT01232725 |
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Recruitment Status :
Completed
First Posted : November 2, 2010
Last Update Posted : August 4, 2017
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Sponsor:
Tarah T Colaizy
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Tarah T Colaizy, University of Iowa
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurodevelopmental Outcomes of VLBW Infants | Dietary Supplement: Donor Human Milk | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 121 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Epidemiologic and Biologic Studies of Donor Human Milk and Breastfeeding |
| Study Start Date : | August 2009 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | May 2016 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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
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Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank |
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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
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Dietary Supplement: Donor Human Milk
Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232725
Locations
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
Sponsors and Collaborators
Tarah T Colaizy
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| Principal Investigator: | Tarah T Colaizy, MD, MPH | University of Iowa |
| 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 ( U.S. NIH Grant/Contract ) |
| First Posted: | November 2, 2010 Key Record Dates |
| Last Update Posted: | August 4, 2017 |
| Last Verified: | August 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Contact PI to discuss data sharing |
Keywords provided by Tarah T Colaizy, University of Iowa:
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BSID III Human Milk Donor Human Milk Preterm infant Breastfeeding |