Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study (IFO Pilot)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christoph Fusch, McMaster Children's Hospital
ClinicalTrials.gov Identifier:
NCT01305642
First received: February 28, 2011
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

To analyze the weight gain of very low birth weight infants during a minimum period of three weeks before 36 weeks postmenstrual age when infants are fed with breast milk that has been individually fortified.


Condition Intervention
Postnatal Growth Disorder
Dietary Supplement: Individualized fortification of breast milk

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Individualized Fortification of Breast Milk for Preterm Infants - A Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster Children's Hospital:

Primary Outcome Measures:
  • growth [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    weight gain will be accessed three times per week


Secondary Outcome Measures:
  • enteral energy intake [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    caloric intake by enteral feeding will be assesed daily

  • growth, tolerance, morbidity [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ] [ Designated as safety issue: No ]
    gains in length and head circumference will be assessed weekly, tolerance and morbidity throughout study


Enrollment: 13
Study Start Date: February 2011
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Individualized fortification of breast milk Dietary Supplement: Individualized fortification of breast milk

Lactose, fat and protein content will be measured prior to breast milk fortification.

Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis.


  Eligibility

Ages Eligible for Study:   up to 32 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birth weight ≤ 1500g and gestational age < 32weeks
  • Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h

Exclusion Criteria:

  • Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk
  • gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities
  • Babies with enterostoma or short gut syndrome
  • Fluid restriction below
  • Renal disease
  • Sepsis
  • Necrotizing enterocolitis
  • Hepatic dysfunction
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305642

Locations
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N3Z5
Sponsors and Collaborators
McMaster Children's Hospital
Investigators
Principal Investigator: Christoph Fusch, MD,PhD,FRCPC McMaster Children's Hospital
  More Information

No publications provided by McMaster Children's Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christoph Fusch, Professor and Division Head, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01305642     History of Changes
Other Study ID Numbers: 201101IFOPILOT
Study First Received: February 28, 2011
Last Updated: May 30, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster Children's Hospital:
Postnatal development
Breast milk fortification
Composition of breast milk

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 14, 2014