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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01305642
First Posted: March 1, 2011
Last Update Posted: August 9, 2016
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.
Information provided by (Responsible Party):
Christoph Fusch, McMaster Children's Hospital
  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: Intervention Model: Single Group Assignment
Masking: None (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 Christoph Fusch, McMaster Children's Hospital:

Primary Outcome Measures:
  • growth [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ]
    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 ]
    caloric intake by enteral feeding will be assesed daily

  • growth, tolerance, morbidity [ Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 32 Weeks   (Child)
Sexes Eligible for Study:   All
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
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): 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

Publications:

Responsible Party: Christoph Fusch, Professor and Division Head, McMaster Children's Hospital
ClinicalTrials.gov Identifier: NCT01305642     History of Changes
Other Study ID Numbers: 201101IFOPILOT
First Submitted: February 28, 2011
First Posted: March 1, 2011
Last Update Posted: August 9, 2016
Last Verified: August 2016

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

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes