Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
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| ClinicalTrials.gov Identifier: NCT01534481 |
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Recruitment Status :
Recruiting
First Posted : February 16, 2012
Last Update Posted : November 9, 2017
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Sponsor:
NICHD Neonatal Research Network
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network
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Brief Summary:
The Milk Trial seeks to determine the effect on neurodevelopmental outcomes at age 22-26 months of donor human milk as compared to preterm infant formula as the in-hospital diet for infants whose mothers choose not to provide breast milk or are able to provide only a minimal amount. Infants will be randomized to receive donor breast milk or formula during their hospital stay. Infant's will be followed until they reach 22-26 months of age.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infant, Newborn Infant, Small for Gestational Age Infant, Extremely Low Birth Weight | Biological: Donor Milk Dietary Supplement: Preterm Formula | Phase 3 |
There is strong evidence that maternal breast milk feedings in infancy confer multiple health benefits in the extremely preterm population (extremely low birth weight, ELBW, <1000 g). Studies suggest an IQ advantage of up to 8 points conferred by maternal milk feeding in this population. Rates of sepsis and necrotizing enterocolitis are also lower in human milk fed ELBW infants, and they experience shorter hospital stays and fewer re-hospitalizations in the first year of life. When mothers choose not to or are unable to provide milk, preterm formula is usually used. Recently, pasteurized donor human milk is available in some NICUs in the US as an alternative to preterm formula. Donor milk has not been well studied with regard to its safety and efficacy. It is unknown if donor human milk confers the same benefits as maternal milk with regard to neurodevelopmental and health outcomes. The proposed study will be the first US multicenter randomized trial of the health and developmental effects of donor milk as compared to preterm formula in ELBW infants receiving little or no maternal milk. Our long-term goal is to optimize neurodevelopmental and health outcomes for ELBW infants, maximizing their quality of life and societal functionality throughout their lives. If donor human milk has similar effects to maternal milk, the public health benefit of donor milk feedings in ELBW infants unable to receive maternal milk would be considerable.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 670 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 |
| Estimated Primary Completion Date : | June 2019 |
| Estimated Study Completion Date : | June 2020 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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 |
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Placebo Comparator: Preterm Formula
Preterm formula determined by center practice
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Dietary Supplement: Preterm Formula
Preterm Formula determined by center practice. |
Primary Outcome Measures :
- Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ]As measured by scores on Bayley Scales of Infant Development III (BSID III)
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | up to 21 Days (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
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): NCT01534481
Contacts
| Contact: Tarah Colaizy, MD, MPH | 319-356-3508 | ||
| Contact: Rosemary D Higgins, MD | 301-496-5575 |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: David Carlton, MD | |
| Principal Investigator: David Carlton, MD | |
| United States, Indiana | |
| Indiana University | Active, not recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Tarah Colaizy, MD, MPH 319-356-3508 | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Michigan | |
| Wayne State University | Active, not recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, Missouri | |
| Children's Mercy Hospital | Active, not recruiting |
| Kansas City, Missouri, United States, 64108 | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, New York | |
| University of Rochester | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carl T D'Angio, MD 585-273-4911 | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: C. Michael Cotten, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| United States, Ohio | |
| Case Western Reserve University, Rainbow Babies and Children's Hospital | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Michele C. Walsh, MD MS | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Pablo Sanchez, MD | |
| Principal Investigator: Pablo Sanchez, MD | |
| United States, Pennsylvania | |
| University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Eric Eichenwald, MD | |
| Principal Investigator: Eric Eichenwald, MD | |
| United States, Rhode Island | |
| Brown University, Women & Infants Hospital of Rhode Island | Recruiting |
| Providence, Rhode Island, United States, 02905 | |
| Contact: Abbot R. Laptook, MD | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Myra Wyckoff, MD | |
| Principal Investigator: Myra Wyckoff, MD | |
| University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Jon E Tyson, MD MPH | |
| Principal Investigator: Jon E. Tyson, MD MPH | |
Sponsors and Collaborators
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
| 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 |
Additional Information:
Keywords provided by NICHD Neonatal Research Network:
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NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Neurodevelopmental Impairment Donor Breast Milk Preterm Formula |
Additional relevant MeSH terms:
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Body Weight Birth Weight Signs and Symptoms |