NCT00413985

Brief Summary

The purpose of this study is to determine whether low birth weight (LBW) infants fed human milk (HM)supplemented with a specially designed powdered human milk fortifier until 12 weeks after hospital discharge will have better growth and neurodevelopment than infants fed HM alone.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

9 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

January 1, 2004

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 20, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

December 31, 2013

Status Verified

December 1, 2013

Enrollment Period

3.8 years

First QC Date

December 19, 2006

Last Update Submit

December 30, 2013

Conditions

Infant, Low Birth Weight

Keywords

Low Birth WeightFortified Human Milkbreastfeedinginfantsgrowth

Outcome Measures

Primary Outcomes (7)

  • Growth (weight, length and head circumference)

  • Body composition (fat-free mass, whole body mineral content, fat mass

  • Milk consumption

  • Estimated energy and nutrient intakes

  • Duration/exclusivity of breastfeeding

  • Morbidity (serious adverse events, hospital re-admissions)

  • Development (mental, motor, visual and language)

Interventions

Nutrient-enriched human milkDRUG

Eligibility Criteria

Age1 Day - 4 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Birth Weight between 750-1800 g
  • Gestational Age at birth between 26 and 32 weeks
  • Singleton or twin birth (for twins to be eligible, both must meet eligibility criteria)
  • Small for Gestational age or appropriate for gestational age
  • ≥ 80% energy received from human milk in the previous three days
  • ≥ 25% of human milk consumed orally in the previous three days
  • Mother agrees to exclusively feed her infant human nilk after discharge
  • If so randomized, parents agree to supplement \~1/2 or the human milk provided to her infant as powdered human milk fortifier for 12 weeks after hospital discharge
  • Subject's parents have voluntarily signed an informed consent form

You may not qualify if:

  • Serious congenital or chromosomal anomalies that will affect growth
  • Grade III or IV periventricular/intraventricular hemorrhage
  • Received steroids within 14 days o randomization
  • Asphyxia (hypoxia or ischemia) es evident by severe and permanent neurological data
  • Maternal incapacity, including maternal cocaine or alcohol abuse dring pregnancy, or concurrent, or mother or infant has tested positive for HIV
  • Principal residence of study family outside GTA
  • Mother unable to verbally communicate in English
  • A single feeding must be fortified \> 24 kcal/oz or \>50% of feeds need to be fortified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

The Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Rouge Valley Centenary

Toronto, Ontario, M1E 4B9, Canada

Location

The Scarborough Hospital

Toronto, Ontario, M1P 2V5, Canada

Location

Toronto East General Hospital

Toronto, Ontario, M4C 3E7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Sunnybrook and Women's Health Sciences Centre

Toronto, Ontario, M5S 1B2, Canada

Location

St. Joseph's Health Centre

Toronto, Ontario, M6R 1B5, Canada

Location

Related Publications (1)

  • O'Connor DL, Khan S, Weishuhn K, Vaughan J, Jefferies A, Campbell DM, Asztalos E, Feldman M, Rovet J, Westall C, Whyte H; Postdischarge Feeding Study Group. Growth and nutrient intakes of human milk-fed preterm infants provided with extra energy and nutrients after hospital discharge. Pediatrics. 2008 Apr;121(4):766-76. doi: 10.1542/peds.2007-0054.

    PMID: 18381542DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Deborah L O'Connor, RD, PhD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief, Clinical Dietetics

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 20, 2006

Study Start

January 1, 2004

Primary Completion

November 1, 2007

Last Updated

December 31, 2013

Record last verified: 2013-12

Locations

CA(9)