Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
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ClinicalTrials.gov Identifier: NCT01534481 |
Recruitment Status :
Completed
First Posted : February 16, 2012
Last Update Posted : November 22, 2021
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Condition or disease | Intervention/treatment | Phase |
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Infant, Newborn Infant, Small for Gestational Age Infant, Extremely Low Birth Weight | Biological: Donor Milk Dietary Supplement: Preterm Formula | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 483 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants |
Actual Study Start Date : | August 2012 |
Actual Primary Completion Date : | November 15, 2021 |
Actual Study Completion Date : | November 15, 2021 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America
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Biological: Donor Milk
Donor milk provided by the Human Milk Banking Association of North America |
Placebo Comparator: Preterm Formula
Preterm formula determined by center practice
|
Dietary Supplement: Preterm Formula
Preterm Formula determined by center practice. |
- Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ]As measured by scores on Bayley Scales of Infant Development III (BSID III)
- In Hospital Morbidities [ Time Frame: Up to one year ]
These include:
- Death
- Late onset sepsis or meningitis
- Length of TPN use
- Length of initial hospital stay
- Necrotizing enterocolitis
- Bronchopulmonary dysplasia (BPD), defined as room air oxygen saturation of less than 90% at 36 weeks postmenstrual age using the NRN standard physiologic definition of BPD.
- Necrotizing enterocolitis or death
- BPD or death
- Growth outcomes [ Time Frame: 36 Weeks and 22-26 months corrected age ]In-Hospital growth parameters, including rate of weight gain, weight, length and head circumference at 36 weeks or discharge, whichever comes first. Weights will be obtained from hospital records weekly, length and head circumference will be measured bi-weekly by study personnel.
- Follow-up Outcomes [ Time Frame: 22-26 months corrected age ]
- Number of hospital admissions between initial discharge and follow-up
- Motor and Language scores on the BSID III
- Cerebral Palsy
- Neurodevelopmental Impairment (NDI), using current Follow-Up Study definition.
- Profound Impairment, defined as BSID III Cognitive subscale score of 70
- NDI or death
- Profound Impairment or death

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Ages Eligible for Study: | up to 21 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Gestational age less than 29 weeks.
- Admitted to the NICU at less than or equal to 72 hours of life
- Survived at least 12 hours
Exclusion Criteria:
- Chromosomal anomalies
- Cyanotic congenital heart disease
- Diagnosed intrauterine infection
- Other congenital disorders known to impair neurodevelopment
- NEC or IP prior to seeking consent
- Decision documented to limit intensive care therapies
- Congenital disorders that may affect feeding
Feeding Group Eligibility:
- Sole Diet Group: Infants will be eligible for the sole diet feeding protocol if the mother declines to provide breast milk for the baby.
- Supplemental Diet (minimal maternal milk) Group: Infants whose mothers initially choose to provide breast milk and begin pumping will be re-screened for eligibility at least weekly until the infant is 21 days old. If the mother stops expressing milk at any point prior to the infant's 21st day of life, her infant will be eligible for randomization. In addition, those whose mothers are providing less than 20% of the infant's dietary needs (averaged over past 5 days) when the infant reaches 21 days of age will be eligible for randomization at this point. No infant will be randomized after reaching 21 days.

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): NCT01534481

Study Director: | Tarah Colaizy, MD, MPH | University of Iowa | |
Principal Investigator: | Michele C Walsh, MD | Case Western Reserve University, Rainbow Babies and Children's Hospital | |
Principal Investigator: | Seetha Shankaran, MD | Wayne State University | |
Principal Investigator: | Abbot R Laptook, MD | Brown University, Women & Infants Hospital of Rhode Island | |
Principal Investigator: | C. Michael Cotten, MD | Duke University | |
Principal Investigator: | David Carlton, MD | Emory University | |
Principal Investigator: | Greg Sokol, MD | Indiana University | |
Principal Investigator: | Abhik Das, PhD | RTI International | |
Principal Investigator: | Krisa P Van Meurs, MD | Stanford University | |
Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham | |
Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico | |
Principal Investigator: | Myra Wyckoff, MD | University of Texas, Southwestern Medical Center at Dallas | |
Principal Investigator: | Jon Tyson, MD, MPH | The University of Texas Health Science Center, Houston | |
Principal Investigator: | Sara DeMauro, MD | University of Pennsylvania | |
Principal Investigator: | Carl T D'Angio, MD | University of Rochester | |
Principal Investigator: | Pablo J Sanchez, MD | Research Institute at Nationwide Children's Hospital | |
Principal Investigator: | William Truog, MD | Children's Mercy Hospital Kansas City |
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Neurodevelopmental Impairment Donor Breast Milk Preterm Formula |
Body Weight Birth Weight |