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

August 8, 2016 updated by: Christoph Fusch, McMaster Children's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N3Z5
        • McMaster Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth
Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks
weight gain will be accessed three times per week
from inclusion at postmentrual age <32 weeks until 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
enteral energy intake
Time Frame: from inclusion at postmentrual age <32 weeks until 36 weeks
caloric intake by enteral feeding will be assesed daily
from inclusion at postmentrual age <32 weeks until 36 weeks
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
from inclusion at postmentrual age <32 weeks until 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster Children's Hospital

Investigators

  • Principal Investigator: Christoph Fusch, MD,PhD,FRCPC, McMaster Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (ACTUAL)

November 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

February 28, 2011

First Submitted That Met QC Criteria

February 28, 2011

First Posted (ESTIMATE)

March 1, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201101IFOPILOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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