NCT01534481

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_3

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 6, 2023

Completed
Last Updated

February 6, 2023

Status Verified

January 1, 2023

Enrollment Period

9.3 years

First QC Date

February 13, 2012

Results QC Date

November 29, 2022

Last Update Submit

February 1, 2023

Conditions

Infant, NewbornInfant, Small for Gestational AgeInfant, Extremely Low Birth Weight

Keywords

NICHD Neonatal Research NetworkExtremely Low Birth Weight (ELBW)PrematurityNeurodevelopmental ImpairmentDonor Breast MilkPreterm Formula

Outcome Measures

Primary Outcomes (1)

  • Bayley Scales of Infant Development (BSID) Cognitive Composite Score

    Mean cognitive composite score (standardized mean 100, SD 15, range 54-145). Subjects who died prior to follow-up assigned the score of 54. (lower scores indicating greater impairment)

    At 22-26 months corrected age

Secondary Outcomes (11)

  • Total Deaths Before Discharge

    From day of randomization to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 1 year following birth

  • Late Onset Sepsis (LOS)

    From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

  • Necrotizing Enterocolitis (NEC)

    From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

  • Death or Necrotizing Enterocolitis (NEC)

    From birth to Neonatal Research Network NRN infant status i.e., the first occurring of: discharge home, death, transfer, or 120 days following birth

  • Change in Weight-for-age Z-score During Study

    During Study Intervention, the time between study randomization and discontinuation of study protocol. Infants exited from the study protocol 1-2 weeks prior to anticipated hospital discharge or 120 days, whichever is sooner

  • +6 more secondary outcomes

Study Arms (2)

Donor Milk

ACTIVE COMPARATOR

Donor milk provided by the Human Milk Banking Association of North America

Biological: Donor Milk

Preterm Formula

PLACEBO COMPARATOR

Preterm formula determined by center practice

Dietary Supplement: Preterm Formula

Interventions

Donor MilkBIOLOGICAL

Donor milk provided by the Human Milk Banking Association of North America

Donor Milk
Preterm FormulaDIETARY_SUPPLEMENT

Preterm Formula determined by center practice.

Preterm Formula

Eligibility Criteria

AgeUp to 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Colaizy TT, Poindexter BB, McDonald SA, Bell EF, Carlo WA, Carlson SJ, DeMauro SB, Kennedy KA, Nelin LD, Sanchez PJ, Vohr BR, Johnson KJ, Herron DE, Das A, Crawford MM, Walsh MC, Higgins RD, Stoll BJ; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; MILK Trial Investigators; Ambalavanan N, Wyckoff MH, D'Angio CT, Bugg GW, Ohls RK, Reynolds AM, Sokol GM, Laptook AR, Olsen SL, White JR, Jadcherla SR, Bajaj M, Parimi PS, Schmidt B, Laughon MM, Barks J, Fisher KA, Hibbs AM, Peralta-Carcelen M, Cook N, Heyne RJ, Cavanaugh B, Adams-Chapman I, Fuller J, Hartley-McAndrew ME, Harmon HM, Duncan AF, Hines AC, Kilbride HW, Richards LA, Maitre NL, Natarajan G, Trembath AN, Carlson MD, Malcolm WF, Wilson-Costello DE; MILK Trial Investigators; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental Outcomes of Extremely Preterm Infants Fed Donor Milk or Preterm Infant Formula: A Randomized Clinical Trial. JAMA. 2024 Feb 20;331(7):582-591. doi: 10.1001/jama.2023.27693.

    PMID: 38497706DERIVED

Related Links

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Dr. Tarah Colaizy
Organization
University of Iowa
tarah-colaizy@uiowa.edu
319-356-3508

Study Officials

  • Tarah Colaizy, MD, MPH

    University of Iowa

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2012

First Posted

February 16, 2012

Study Start

August 1, 2012

Primary Completion

November 30, 2021

Study Completion

November 30, 2021

Last Updated

February 6, 2023

Results First Posted

February 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)

Locations

US(17)