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Dietary Supplement
Individualized Breast Milk Fortification for Growth Disorders (IFO Trial)
N/A
Waitlist Available
Led By Christph Fusch, MD, PhD, FRCPC
Research Sponsored by McMaster Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from inclusion at postmentrual age <32 weeks until 18 month corrected age
Awards & highlights
IFO Trial Summary
This trial will investigate whether individualized fortification of breast milk will improve the nutritional intake of preterm infants and optimize their growth and neurodevelopment.
Who is the study for?
This trial is for preterm infants born before 32 weeks of gestation, who can tolerate a certain amount of feeding and are expected to need the intervention for at least three weeks. Infants with renal disease, liver dysfunction, growth restriction or involved in other trials affecting outcomes are excluded.Check my eligibility
What is being tested?
The study tests if adding extra nutrients to breast milk based on daily analysis (individualized fortification) leads to better growth and neurological development in preterm infants compared to standard fortification. The babies' growth will be monitored closely using non-invasive methods.See study design
What are the potential side effects?
Since this trial involves nutritional supplementation of breast milk, side effects may include digestive issues related to intolerance of the fortified milk such as gas, bloating or changes in stool patterns.
IFO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can tolerate eating or drinking more than 100 ml per kg of my body weight daily.
IFO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from inclusion at postmentrual age <32 weeks until 18 month corrected age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from inclusion at postmentrual age <32 weeks until 18 month corrected age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
growth during first three weeks of intervention
Secondary outcome measures
body composition
body composition (bio-electrical impedance analysis)
body length
+9 moreIFO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Individualized fortification of breast milkExperimental Treatment1 Intervention
Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding.
Routine fortifier will be added to breast milk batches.
Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.
Group II: Routine fortification of breast milkActive Control1 Intervention
Macronutrient content (for protein, carbohydrate and fat content) will be analyzed of native breast milk batches which had been prepared for 24 hr feeding.
Routine fortifier will be added to breast milk batches.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Individualized fortification of breast milk
2011
N/A
~20
Find a Location
Who is running the clinical trial?
McMaster Children's HospitalLead Sponsor
38 Previous Clinical Trials
17,213 Total Patients Enrolled
Christph Fusch, MD, PhD, FRCPCPrincipal InvestigatorMcMaster Children's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can tolerate eating or drinking more than 100 ml per kg of my body weight daily.I have liver problems indicated by high bilirubin and abnormal liver tests.My baby has an enterostoma or short gut syndrome.My baby has a severe intestinal issue confirmed by specific x-ray signs.I have kidney problems with symptoms like low urine output or blood in my urine.My baby was born smaller than the lowest 3% for their gestational age.I am expected to receive treatment for at least 3 weeks after reaching full feeding.You have significant birth defects or problems with your digestive system or chromosomes.
Research Study Groups:
This trial has the following groups:- Group 1: Individualized fortification of breast milk
- Group 2: Routine fortification of breast milk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are researchers currently accepting new participants for this experiment?
"According to the clinicaltrials.gov records, this medical trial is no longer seeking applicants; it was originally posted on August 1st 2013 and last updated three years later. However, there are currently 10 other active trials recruiting patients at present."
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