Clinical trial NCT05308134: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
Official title: MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Very Low Birth Weight Infant
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 615
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 fortification of human milk is routine in most neonatal units in North America, but despite the added nutrients, infants are often discharged from hospitals with poor growth, and their neurodevelopment remains suboptimal. Two individualized fortification methods, target and BUN adjustable, have been proposed to improve the nutrient supply to infants. However, there is currently insufficient evidence to support the implementation of individualized fortification or one method over the other. Therefore, this study will randomly assign very low birth weight infants to receive feeds fortified according to standard, target or BUN adjustable fortification methods until the end of the feeding intervention. Feedings will be prepared in milk preparation rooms to ensure caregivers and outcomes assessor remain blinded to feeding allocation. Growth, morbidities, and nutrient intakes will be determined throughout hospitalization and skinfolds assessed at 36 weeks. At 4 months CA, growth and body composition will be determined by air displacement plethysmography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.

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+0 weeks intervention end-date is in the situation where an infant remains hospitalized but has not completed at least four weeks of the feeding intervention (i.e. 4 weeks following Study Day 1).

Eligibility criteria: Inclusion Criteria:

* ≤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 Criteria:

* Infant received fortifier or formula before Study Day 1.
* Study Day 1 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.

Primary outcomes:
measure: Cognitive Composite Score
timeFrame: 18-24 months corrected age
Secondary outcomes:
measure: Language Composite Score
timeFrame: 18-24 months CA
measure: Motor Composite Score
timeFrame: 18-24 months CA
measure: Weight Gain during the intervention
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Length gain during the intervention
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Head circumference gain during the intervention
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Body composition at the end of the intervention
timeFrame: 36 weeks corrected age
measure: Serious Morbidity
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Health Economics
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Weight at follow-up
timeFrame: 4 months corrected age
measure: Length at follow-up
timeFrame: 4 months corrected age
measure: Head Circumference at follow-up
timeFrame: 4 months corrected age
measure: Body composition at follow-up (approximated)
timeFrame: 4 months corrected age
measure: Body composition at follow-up (direct measurement)
timeFrame: 4 months corrected age
Other outcomes:
measure: Milk Type Received
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Energy and Nutrient Intakes of Infants
timeFrame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
measure: Maternal Diet During Lactation
timeFrame: Study Day 35±3
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Brampton
country: Canada
facility: William Osler Health System-Brampton Civic Hospital
state: Ontario
city: Etobicoke
country: Canada
facility: William Osler Health System-Etobicoke General Hospital
state: Ontario
city: Markham
country: Canada
facility: Markham Stouffville Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners-Missisauga Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Health Partners-Credit Valley Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: North York
country: Canada
facility: Humber River Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Lakeridge Health
state: Ontario
city: Richmond Hill
country: Canada
facility: Mackenzie Health
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network-Centenary Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network-General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto-St Michaels Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sinai Health System-Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto-St Josephs Health Centre
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Deborah O'Connor, PhD RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sinai Health System
name: Sharon Unger, MD
role: PRINCIPAL_INVESTIGATOR
References: