We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post Discharge Human Milk Fortifier in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00413985
Recruitment Status : Completed
First Posted : December 20, 2006
Last Update Posted : December 31, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Infant, Low Birth Weight Drug: Nutrient-enriched human milk Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Growth and Development in Preterm Infants Fed Human Milk Containing a Powdered Human Milk Fortifier (HMF) Post Hospital Discharge
Study Start Date : January 2004
Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Growth (weight, length and head circumference)
  2. Body composition (fat-free mass, whole body mineral content, fat mass
  3. Milk consumption
  4. Estimated energy and nutrient intakes
  5. Duration/exclusivity of breastfeeding
  6. Morbidity (serious adverse events, hospital re-admissions)
  7. Development (mental, motor, visual and language)

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413985


Locations
Canada, Ontario
The Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Rouge Valley Centenary
Toronto, Ontario, Canada, M1E 4B9
The Scarborough Hospital
Toronto, Ontario, Canada, M1P 2V5
Toronto East General Hospital
Toronto, Ontario, Canada, M4C 3E7
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sunnybrook and Women's Health Sciences Centre
Toronto, Ontario, Canada, M5S 1B2
St. Joseph's Health Centre
Toronto, Ontario, Canada, M6R 1B5
Sponsors and Collaborators
The Hospital for Sick Children
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Deborah L O'Connor, RD, PhD The Hospital for Sick Children, Toronto Canada
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deborah O'Connor, Associate Chief, Clinical Dietetics, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00413985     History of Changes
Other Study ID Numbers: 1000003971
First Posted: December 20, 2006    Key Record Dates
Last Update Posted: December 31, 2013
Last Verified: December 2013

Keywords provided by Deborah O'Connor, The Hospital for Sick Children:
Low Birth Weight
Fortified Human Milk
breastfeeding
infants
growth

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms