Status:
RECRUITING
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Very Low Birth Weight Infant
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief Summary
Very low birth weight infants have increased nutritional needs. Extra nutrients are added to their human milk feeds to help improve their nutritional status, growth and neurodevelopment. Standard fort...
Detailed Description
The end of the feeding intervention is defined as: the infant is 36+0 weeks CA, is discharged home, or receives two oral feeds daily for three consecutive days without top-up. The exception to the 36+...
Eligibility Criteria
Inclusion
- ≤1250 g birth weight or Gestational Age \<30+0 weeks and \<1500 g birth weight.
- Parental/guardian consent to participate.
- Consent for the use of pasteurized donor milk if mother's milk is not available.
Exclusion
- Infant received fortifier or formula before Study Day 1.
- Study Day 1 anticipated to occur after postnatal day 21.
- Infants with congenital or chromosomal anomalies or brain injury that may affect growth or neurodevelopment.
- Enrollment in any other clinical study affecting nutritional management during the feeding intervention.
- Reasonable potential that the infant will be transferred to a NICU where the study protocol will not be continued before they have completed at least 4 weeks of the feeding intervention.
Key Trial Info
Start Date :
November 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
615 Patients enrolled
Trial Details
Trial ID
NCT05308134
Start Date
November 11 2021
End Date
July 1 2026
Last Update
July 31 2025
Active Locations (20)
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1
University of Alberta
Edmonton, Alberta, Canada, T6G 2R3
2
William Osler Health System-Brampton Civic Hospital
Brampton, Ontario, Canada, L6R 3J7
3
William Osler Health System-Etobicoke General Hospital
Etobicoke, Ontario, Canada, M9V 1R8
4
Markham Stouffville Hospital
Markham, Ontario, Canada, L3P 7P3