Human Milk-derived Fortification in Preterm Infants
Primary Purpose
Postnatal Growth Restriction, Necrotizing Enterocolitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Human milk-derived HMF
bovine milk-derived HMF
Sponsored by
About this trial
This is an interventional supportive care trial for Postnatal Growth Restriction focused on measuring Human milk
Eligibility Criteria
Inclusion Criteria:
- Birthweight between 400 g-1250 g
- Less than or 32 weeks gestational age at birth
- Subject has been classified as appropriate for gestational age
- Enteral feeding of human milk is initiated by 72 hours
- Subject is expected to be on human milk for at least 3 weeks.
Exclusion Criteria:
- Congenital abnormalities or underlying disease that may affect growth
- Maternal cocaine, alcohol, or opioid abuse during pregnancy
- Mother or infant is currently receiving treatment for HIV infection
- Infant with major surgery
Sites / Locations
- Foothills Medical Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Human milk-derived HMF
Bovine milk-derived HMF
Arm Description
Fortification with human milk-derived product
Current standard practice: Fortification with bovine milk-derived product
Outcomes
Primary Outcome Measures
Average weight gain
Average weight gain measured as g/kg per day
Secondary Outcome Measures
Head circumference
Measurement of head circumference in centimeters
Length
Measurement of length in centimeters
Feed intolerance
Incidence of interruption in enteral feeding due to feed intolerance (vomiting or abdominal distension), unrelated to a clinical procedure, that lasted for ≥12 hours or a >50% reduction in volume over the same time frame.
Electrolytes abnormalities
Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus
Need for additional signal nutrient supplementation
Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.
Full Information
NCT ID
NCT05228847
First Posted
January 14, 2022
Last Updated
November 4, 2022
Sponsor
University of Calgary
1. Study Identification
Unique Protocol Identification Number
NCT05228847
Brief Title
Human Milk-derived Fortification in Preterm Infants
Official Title
Effect of Human Milk-derived Fortifiers on Weight Gain in Preterm Infants <1250 g: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 15, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Human Milk alone is unable to meet the high nutritional requirements of preterm infants. The American Academy of Pediatrics recommends fortification of human milk as a standard practice in all very low birth weight (VLBW) infants. Multi-nutrient human milk fortifiers (HMFs) are designed to meet the macro and micro-nutrient needs of VLBW infants. HMFs differ by the origin of milk and by nutrient composition. Traditionally, bovine milk has been the main source of multi-nutrient HMFs.
Detailed Description
Recent advances in lacto-engineering techniques allowed the manufacturing of multi-nutrient HMF from human milk as an alternative to bovine milk. Since exposure to infant bovine-based formula feeds is frequently shown to increase neonatal morbidities, human milk-derived HMFs (H-HMFs) have been frequently proposed to minimize exposure to bovine products prior to 34 weeks gestation with an intent to decrease the risks of necrotizing enterocolitis and feeding intolerance. The use of multi-nutrient H-HMFs is a promising intervention however currently available H-HMFs are expensive.
The main objective of this randomized controlled trial is to compare the weight gain achieved by preterm infants born <1250 g and fed human milk fortified with H-HMFs (made from mother's own milk (MOM) when MOM supply exceeds the daily need of her preterm infant or from donor human milk (DHM) compared with counterparts fed human milk fortified with the currently used bovine-derived fortifier (B-HMF).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postnatal Growth Restriction, Necrotizing Enterocolitis
Keywords
Human milk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Human milk-derived HMF
Arm Type
Active Comparator
Arm Description
Fortification with human milk-derived product
Arm Title
Bovine milk-derived HMF
Arm Type
Other
Arm Description
Current standard practice: Fortification with bovine milk-derived product
Intervention Type
Dietary Supplement
Intervention Name(s)
Human milk-derived HMF
Intervention Description
Fortification with human milk-derived product
Intervention Type
Dietary Supplement
Intervention Name(s)
bovine milk-derived HMF
Intervention Description
bovine milk-derived HMF
Primary Outcome Measure Information:
Title
Average weight gain
Description
Average weight gain measured as g/kg per day
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
Head circumference
Description
Measurement of head circumference in centimeters
Time Frame
Weekly for 8 weeks
Title
Length
Description
Measurement of length in centimeters
Time Frame
Weekly for 8 weeks
Title
Feed intolerance
Description
Incidence of interruption in enteral feeding due to feed intolerance (vomiting or abdominal distension), unrelated to a clinical procedure, that lasted for ≥12 hours or a >50% reduction in volume over the same time frame.
Time Frame
3 weeks
Title
Electrolytes abnormalities
Description
Incidence of any abnormality in one of the following electrolytes: sodium, potassium, calcium and phosphorus
Time Frame
3 weeks
Title
Need for additional signal nutrient supplementation
Description
Number of additions of single nutrient supplementation (include protein, fat and carbohydrate) in each group.
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birthweight between 400 g-1250 g
Less than or 32 weeks gestational age at birth
Subject has been classified as appropriate for gestational age
Enteral feeding of human milk is initiated by 72 hours
Subject is expected to be on human milk for at least 3 weeks.
Exclusion Criteria:
Congenital abnormalities or underlying disease that may affect growth
Maternal cocaine, alcohol, or opioid abuse during pregnancy
Mother or infant is currently receiving treatment for HIV infection
Infant with major surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belal Alshaikh, MD, MSc
Phone
4039561588
Email
balshaik@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belal Alshaikh, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N2T9
Country
Canada
12. IPD Sharing Statement
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Human Milk-derived Fortification in Preterm Infants
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