NCT00506584

Brief Summary

The purpose of this study is to determine whether very low birth weight infants (less than or equal to 1250g or about 2 3/4 pounds) born prematurely fed a diet of only human milk and human milk-derived nutrition have better health outcomes than babies fed at least some formula (made from cow's milk)or formula-derived nutrition.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
2 countries

13 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

Study Start

First participant enrolled

July 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

February 18, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

July 20, 2007

Last Update Submit

February 16, 2010

Conditions

Infant, Very Low Birth Weight

Keywords

Human milk nutritional interventionPre-term, very low birth weightFortification of human breast milk

Outcome Measures

Primary Outcomes (1)

  • The primary measure of efficacy for the study is the number of days of TPN (total parenteral nutrition)

    The first 90 days of life, discharge from the study institution or initiation of 50% oral nutrition (50% of the feeding volume in a given 24 hour period provided PO, or 4 complete PO feeds in a given 24 hour period), whichever comes first

Secondary Outcomes (5)

  • Weight gain and other measures of growth including length and head circumference

    The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first

  • Daily amount of all nutrition

    The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first

  • Time to discharge from the NICU and hospital

    The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first

  • Frequency of occurrence of late-onset sepsis and necrotizing enterocolitis

    The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first

  • Frequency of feeding intolerance

    The first 90 days of life, transfer to non-study institution, or initiation of 50% oral feeding, whichever comes first

Study Arms (5)

Group 1, arm 1

EXPERIMENTAL

Human breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day, where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk.

Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier

Group1, Arm 2

EXPERIMENTAL

Human breast milk + Prolact20/Neo20 (as needed) + Prolact+4 (initiated when nutrition volume reaches 40 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk.

Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier

Group 1, Arm 3

ACTIVE COMPARATOR

Human breast milk + bovine-based human milk fortifier (initiated when nutrition volume reaches 100 mL/kg/day) + pre-term formula (as needed)

Dietary Supplement: Human milk fortifier (bovine-based), pre-term formula

Group 2, Arm 1

EXPERIMENTAL

Prolact20/Neo20 + Prolact+4 (initiated when nutrition volume reaches 100 mL/kg/day), where Prolact20/Neo 20 are donor human milk formulations at 20 cal/oz, Prolact+4 is a human-milk derived human milk fortified designed to add 4 cal/oz to 20 cal/oz human breast milk.

Dietary Supplement: Pasteurized human milk and pasteurized human milk fortifier

Group 2, Arm 2

ACTIVE COMPARATOR

Pre-term/term formula (minimum 20 cal/oz)

Dietary Supplement: Pre-term/term formula

Interventions

Pasteurized human milk and pasteurized human milk fortifierDIETARY_SUPPLEMENT

Human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day

Also known as: Prolact20/Neo20, Prolact+4
Group 1, arm 1
Human milk fortifier (bovine-based), pre-term formulaDIETARY_SUPPLEMENT

Bovine-based human milk fortifier is initiated when nutrition volume reaches 100 mL/kg/day

Group 1, Arm 3
Pre-term/term formulaDIETARY_SUPPLEMENT

Bovine milk-derived nutrition formulated for very low birth weight infants

Group 2, Arm 2

Eligibility Criteria

Age1 Day - 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth weight between 500 and 1250g.
  • Have a reasonable expectation of survival for the maximum 90 day duration of the study.
  • In "Study Group 1", must be able to adhere to a feeding protocol involving mother's own milk and that may include donor human milk with fortification using a human-based product (Prolact+4) or fortification with a bovine-based human milk fortifier and the use of a pre-term/term formula; or in "Study Group 2" the use of donor human milk with Prolact+4 or a pre-term/term formula from the time that the infant initiates enteral feeding through day 90 of life, until discharge from the study institution, discharge home, death or the initiation of at least 50% total oral nutrition (4 complete feeds in a 24 hour period), whichever comes first.
  • Enteral feeding must begin before the 21st day of life.
  • Total parenteral nutrition (TPN) initiated within 48 hours after birth.
  • Informed consent obtained from parent or legal guardian.

You may not qualify if:

  • Less than a reasonable expectation of survival for the infant's particular gestational age through the study period (first 90 days of life, discharge to a non-study institution, discharge home, death or initiation of 50% oral nutrition, whichever comes first).
  • On any other clinical study affecting nutritional management during the study period.
  • Decision to not start minimum enteral feed before day 21 of life.
  • Decision to not start TPN within the first 48 hours after birth.
  • Unable to obtain informed consent from parent or legal guardian prior to the initiation of enteral feeding.
  • Presence of clinically significant congenital heart disease.
  • Presence of any major congenital malformations.
  • Reasonable potential for early transfer to a non-study institution.
  • Unable to participate for any reason based on the decision of the study investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Alta Bates Summit Medical Center

Berkeley, California, 94705, United States

Location

University of California, San Diego Medical Center

San Diego, California, 92103-8774, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Shands Children's Hospital

Gainesville, Florida, 32610-0296, United States

Location

Rush-Presbyterian St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Schneider Children's Hospital at North Shore

Manhasset, New York, 11030, United States

Location

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ben Taub Hospital/Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229-3900, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Innsbruck Children's Hospital

Innsbruck, A-6020, Austria

Location

Related Publications (4)

  • Sullivan S, Schanler RJ, Kim JH, Patel AL, Trawoger R, Kiechl-Kohlendorfer U, Chan GM, Blanco CL, Abrams S, Cotten CM, Laroia N, Ehrenkranz RA, Dudell G, Cristofalo EA, Meier P, Lee ML, Rechtman DJ, Lucas A. An exclusively human milk-based diet is associated with a lower rate of necrotizing enterocolitis than a diet of human milk and bovine milk-based products. J Pediatr. 2010 Apr;156(4):562-7.e1. doi: 10.1016/j.jpeds.2009.10.040. Epub 2009 Dec 29.

    PMID: 20036378RESULT

  • Quigley M, Embleton ND, Meader N, McGuire W. Donor human milk for preventing necrotising enterocolitis in very preterm or very low-birthweight infants. Cochrane Database Syst Rev. 2024 Sep 6;9(9):CD002971. doi: 10.1002/14651858.CD002971.pub6.

    PMID: 39239939DERIVED

  • Cristofalo EA, Schanler RJ, Blanco CL, Sullivan S, Trawoeger R, Kiechl-Kohlendorfer U, Dudell G, Rechtman DJ, Lee ML, Lucas A, Abrams S. Randomized trial of exclusive human milk versus preterm formula diets in extremely premature infants. J Pediatr. 2013 Dec;163(6):1592-1595.e1. doi: 10.1016/j.jpeds.2013.07.011. Epub 2013 Aug 20.

    PMID: 23968744DERIVED

  • Ghandehari H, Lee ML, Rechtman DJ; H2MF Study Group. An exclusive human milk-based diet in extremely premature infants reduces the probability of remaining on total parenteral nutrition: a reanalysis of the data. BMC Res Notes. 2012 Apr 25;5:188. doi: 10.1186/1756-0500-5-188.

    PMID: 22534258DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Richard J Schanler, MD

    Schneider Children's Hospital at North Shore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 20, 2007

First Posted

July 25, 2007

Study Start

July 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

February 18, 2010

Record last verified: 2010-02

Locations

AU(1)US(12)