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Post Discharge Human Milk Fortifier in Preterm Infants

Primary Purpose

Infant, Low Birth Weight

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nutrient-enriched human milk
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infant, Low Birth Weight focused on measuring Low Birth Weight, Fortified Human Milk, breastfeeding, infants, growth

Eligibility Criteria

1 Day - 4 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • The Credit Valley Hospital
  • Rouge Valley Centenary
  • The Scarborough Hospital
  • Toronto East General Hospital
  • St. Michael's Hospital
  • Mount Sinai Hospital
  • The Hospital for Sick Children
  • Sunnybrook and Women's Health Sciences Centre
  • St. Joseph's Health Centre

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
December 19, 2006
Last Updated
December 30, 2013
Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00413985
Brief Title
Post Discharge Human Milk Fortifier in Preterm Infants
Official Title
Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. Study Description

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.
Detailed Description
Consensus exists in the literature that a significant proportion of low birth weight (LBW, <1800 g) infants leave hospital with overt signs of under-nutrition (eg. growth retardation). Recent evidence from randomized control trials suggest that provision of nutrient-enriched feeding to formula-fed premature infants after hospital discharge improves their growth, accretion of lean body mass and bone mineral content compared to infants fed a standard term formula. While available data suggest an advantage of human milk feeding after hospital discharge, experimental evidence on which to base guidelines to enrich, or not to enrich, human milk (HM) are notably absent.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant, Low Birth Weight
Keywords
Low Birth Weight, Fortified Human Milk, breastfeeding, infants, growth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nutrient-enriched human milk
Primary Outcome Measure Information:
Title
Growth (weight, length and head circumference)
Title
Body composition (fat-free mass, whole body mineral content, fat mass
Title
Milk consumption
Title
Estimated energy and nutrient intakes
Title
Duration/exclusivity of breastfeeding
Title
Morbidity (serious adverse events, hospital re-admissions)
Title
Development (mental, motor, visual and language)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L O'Connor, RD, PhD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Facility Name
Rouge Valley Centenary
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1E 4B9
Country
Canada
Facility Name
The Scarborough Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1P 2V5
Country
Canada
Facility Name
Toronto East General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Sunnybrook and Women's Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
St. Joseph's Health Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6R 1B5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18381542
Citation
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.
Results Reference
derived

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Post Discharge Human Milk Fortifier in Preterm Infants

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