Donor Milk vs. Formula in Extremely Low Birth Weight (ELBW) Infants
This study is currently recruiting participants.
Verified January 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01534481
First received: February 13, 2012
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Infant, Newborn Infant, Small for Gestational Age Infant, Extremely Low Birth Weight |
Biological: Donor Breast Milk Dietary Supplement: Preterm Formula |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in Extremely Low Birth Weight (ELBW) Infants |
Resource links provided by NLM:
Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- Neurodevelopmental Outcome [ Time Frame: 22-26 months corrected age ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- 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
| Estimated Enrollment: | 670 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Donor Milk |
Biological: Donor Breast Milk
Donor milk provided by the Human Milk Banking Association of North America
|
| Placebo Comparator: Preterm Formula |
Dietary Supplement: Preterm Formula
Preterm Formula determined by center practice.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | up to 21 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Birth weight less than or equal to 1000 grams.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534481
Contacts
| Contact: Tarah Colaizy, MD, MPH | 319-356-3508 | tarah-colaizy@uiowa.edu |
| Contact: Rosemary D Higgins, MD | (301) 435-7909 | higginsr@mail.nih.gov |
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | Not yet recruiting |
| Birmingham, Alabama, United States, 35233 | |
| Contact: Waldemar A. Carlo, MD 205-934-4680 wcarlo@peds.uab.edu | |
| Contact: Monica V. Collins, RN BSN (205) 934-5771 mcollins@peds.uab.edu | |
| Principal Investigator: Waldemar A. Carlo, MD | |
| United States, California | |
| Stanford University | Not yet recruiting |
| Palo Alto, California, United States, 94304 | |
| Contact: Krisa P. Van Meurs, MD 650-723-5711 vanmeurs@leland.stanford.edu | |
| Contact: M. Bethany Ball, BS CCRC (650) 725-8342 mbball@stanford.edu | |
| Principal Investigator: Krisa P. Van Meurs, MD | |
| United States, Georgia | |
| Emory University | Recruiting |
| Atlanta, Georgia, United States, 30303 | |
| Contact: Barbara J. Stoll, MD 404-727-5740 barbara_stoll@oz.ped.emory.edu | |
| Contact: Ellen Hale, RN BS (404) 616-4218 ellen_hale@oz.ped.emory.edu | |
| Principal Investigator: Barbara J. Stoll, MD | |
| United States, Indiana | |
| Indiana University | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Brenda B. Poindexter, MD MS 317-274-3592 bpoindex@iupui.edu | |
| Contact: Leslie D. Wilson, RN BSN (317) 274-8255 ldw@iupui.edu | |
| Principal Investigator: Brenda B. Poindexter, MD MS | |
| United States, Iowa | |
| University of Iowa | Not yet recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Tarah Colaizy, MD, MPH 319-356-3508 tarah-colaizy@uiowa.edu | |
| Contact: Karen J. Johnson, RN BSN (319) 356-2924 karen-johnson@uiowa.edu | |
| Principal Investigator: Edward F. Bell, MD | |
| United States, Michigan | |
| Wayne State University | Not yet recruiting |
| Detroit, Michigan, United States, 48201 | |
| Contact: Seetha Shankaran, MD 313-580-4452 sshankar@med.wayne.edu | |
| Contact: Rebecca Bara, RN BSN (313) 745-1436 rbara@med.wayne.edu | |
| Principal Investigator: Seetha Shankaran, MD | |
| United States, Missouri | |
| Children's Mercy Hospital | Recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: William Truog, MD 816-234-3592 wtruog@cmh.edu | |
| Contact: Cheri Gauldin, BSN (816) 234-3920 cagauldin@cmh.edu | |
| Principal Investigator: William Truog, MD | |
| United States, New Mexico | |
| University of New Mexico | Recruiting |
| Albuquerque, New Mexico, United States, 87131 | |
| Contact: Kristi L. Watterberg, MD 505-272-3967 kwatterberg@salud.unm.edu | |
| Contact: Conra Backstrom Lacy, RN (505) 272-0367 cbackstrom@salud.unm.edu | |
| Principal Investigator: Kristi L. Watterberg, MD | |
| United States, New York | |
| University of Rochester | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Carl T D'Angio, MD 585-273-4911 carl_dangio@urmc.rochester.edu | |
| Contact: Holly Wadkins 585-275-0218 Holly_Wadkins@urmc.rochester.edu | |
| Principal Investigator: Carl T D'Angio, MD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Ronald N. Goldberg, MD 919-681-6025 goldb008@mc.duke.edu | |
| Contact: Gloria Siaw, BSN CRA (919) 681-5859 gloria.siaw@duke.edu | |
| Principal Investigator: Ronald N. Goldberg, MD | |
| Sub-Investigator: C. Michael Cotten, MD MHS | |
| RTI International | Active, not recruiting |
| Durham, North Carolina, United States, 27705 | |
| 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 216-844-3759 mcw3@cwru.edu | |
| Contact: Nancy S. Newman, BA RN (216) 368-3084 nxs5@cwru.edu | |
| Principal Investigator: Michele C. Walsh, MD MS | |
| Research Institute at Nationwide Children's Hospital | Recruiting |
| Columbus, Ohio, United States, 43205 | |
| Contact: Leif Nelin, MD 614-722-3030 Leif.Nelin@nationwidechildrens.org | |
| Contact: Christine Fortney, MS, RN 614-722-6489 christine.fortney@nationwidechildrens.org | |
| Principal Investigator: Leif Nelin, MD | |
| United States, Pennsylvania | |
| Univeristy of Pennsylvania | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Barbara Schmidt, MD 215-662-3228 barbara.schmidt@uphs.upenn.edu | |
| Contact: Aasma Chaudhary, BS 215-615-5442 aasma.chaudhary@uphs.upenn.edu | |
| Principal Investigator: Barbara Schmidt, 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 401-274-1122 alaptook@WIHRI.org | |
| Contact: Angelita Hensman (401) 274-1122 ahensman@wihri.org | |
| Principal Investigator: Abbot R. Laptook, MD | |
| United States, Texas | |
| University of Texas Southwestern Medical Center at Dallas | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Pablo J. Sanchez, MD 214-648-3753 Pablo.Sanchez@UTSouthwestern.edu | |
| Contact: Diana M. Vasil, RNC-NIC (214) 648-3789 Diana.Vasil@utsouthwestern.edu | |
| Principal Investigator: Pablo J. Sanchez, MD | |
| University of Texas Health Science Center at Houston | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Kathleen A. Kennedy, MD MPH 713-500-6708 Kathleen.A.Kennedy@uth.tmc.edu | |
| Contact: Georgia E. McDavid, RN (713) 500-5734 Georgia.E.McDavid@uth.tmc.edu | |
| Principal Investigator: Kathleen A. Kennedy, MD MPH | |
| Sub-Investigator: Jon E. Tyson, MD MPH | |
Sponsors and Collaborators
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: | Ron N Goldberg, MD | Duke University |
| Principal Investigator: | Barbara J Stoll, MD | Emory University |
| Principal Investigator: | Brenda B Poindexter, MD, MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University |
| Principal Investigator: | Kurt Schibler, MD | Cincinnati Children's Medical Center |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Kristi L Watterberg, MD | University of New Mexico |
| Principal Investigator: | Pablo J Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A Kennedy, MD, MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Barbara Schmidt, MD | University of Pennsylvania |
| Principal Investigator: | Carl T D'Angio, MD | University of Rochester |
| Principal Investigator: | Leif Nelin, MD | Research Institute at Nationwide Children's Hospital |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital-Kansas City, MO |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT01534481 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0047, U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880, U10HD034216, U10HD021373, U10HD040492, U10HD053109, U10HD040461, U10HD068244, U10HD068263, U10HD068278, U10HD068284, U10HD036790 |
| Study First Received: | February 13, 2012 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Neurodevelopmental Impairment Donor Breast Milk Preterm Formula |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013