Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants



Status:Recruiting
Conditions:Obesity Weight Loss, Women's Studies
Therapuetic Areas:Endocrinology, Reproductive
Healthy:No
Age Range:Any
Updated:11/11/2017
Start Date:August 2012
End Date:June 2020
Contact:Tarah Colaizy, MD, MPH
Phone:319-356-3508

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Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants

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.

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.

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.
We found this trial at
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(505) 277-0111
Principal Investigator: Kristi L. Watterberg, MD
Phone: 505-272-8609
University of New Mexico Founded in 1889 as New Mexico’s flagship institution, the University of...
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201 Dowman Dr
Atlanta, Georgia 30303
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Principal Investigator: David Carlton, MD
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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5323 Harry Hines Blvd
Dallas, Texas 75235
(214) 648-3111
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Phone: 214-648-3923
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Seetha Shankaran, MD
Phone: 313-745-1436
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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3040 East Cornwallis RoadTriangle
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Durham, North Carolina 27710
(919) 684-8111
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
Principal Investigator: Jon E. Tyson, MD MPH
Phone: 713-500-6708
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Brenda B. Poindexter, MD MS
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
Principal Investigator: Edward F. Bell, MD
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University of Iowa With just over 30,000 students, the University of Iowa is one of...
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2401 Gillham Rd
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: William Truog, MD
Phone: 816-234-3592
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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Providence, Rhode Island 02905
Principal Investigator: Abbot R. Laptook, MD
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
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Phone: 585-273-4911
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Cleveland, Ohio 44106
Principal Investigator: Michele C. Walsh, MD MS
Phone: 216-844-3387
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Columbus, Ohio 43205
Principal Investigator: Pablo Sanchez, MD
Phone: 614-355-6724
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Palo Alto, California 94304
Principal Investigator: Krisa P. Van Meurs, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Principal Investigator: Eric Eichenwald, MD
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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