Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)

Very Low Birth Weight Infant Clinical Trial

Official title:

MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05308134
• Other study ID #: 1861
• Status: Recruiting
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: April 2022
• Source: The Hospital for Sick Children
• Contact: Deborah O'Connor, PhD RD
• Phone: 416-813-7844
• Email: deborah_l.oconnor[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 36 weeks gestational age or hospital discharge whichever occurs first. 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 and processing speed by electroencephalography on a subset of infants. Neurodevelopment will be assessed using the Bayley Scales of Infant and Toddler Development, at 18-24 months CA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 615
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Days

Eligibility

Inclusion Criteria:

• =1250 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 day 21 of life.
• Infants with congenital or chromosomal anomalies that may affect growth outcome.
• 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.

Related Conditions & MeSH terms

• Birth Weight
• Very Low Birth Weight Infant

Intervention

Other:
• Standard fortification
Standard fortification assumes that the nutrient content of human milk is constant and involves use of a standard fixed dose of multi-nutrient fortifier and as appropriate nutrient modulars.
• Target fortification
Target fortification involves use of a multi-nutrient fortifier as well as weekly analysis of energy and macronutrients of human milk and subsequent addition of fat and protein modulars if needed.
• BUN adjustable fortification
BUN (blood urea nitrogen) adjustable fortification involves use of a multi-nutrient fortifier as well as weekly BUN tests and subsequent addition of a protein modular according to a prescribed algorithm.

Locations

Country	Name	City	State
Canada	William Osler Health System-Brampton Civic Hospital	Brampton	Ontario
Canada	University of Alberta	Edmonton	Alberta
Canada	William Osler Health System-Etobicoke General Hospital	Etobicoke	Ontario
Canada	Markham Stouffville Hospital	Markham	Ontario
Canada	Trillium Health Partners-Credit Valley Hospital	Mississauga	Ontario
Canada	Trillium Health Partners-Missisauga Hospital	Mississauga	Ontario
Canada	Southlake Regional Health Centre	Newmarket	Ontario
Canada	Humber River Hospital	North York	Ontario
Canada	North York General Hospital	North York	Ontario
Canada	Lakeridge Health	Oshawa	Ontario
Canada	Mackenzie Health	Richmond Hill	Ontario
Canada	Scarborough Health Network-Centenary Hospital	Scarborough	Ontario
Canada	Scarborough Health Network-General Hospital	Scarborough	Ontario
Canada	Michael Garron Hospital	Toronto	Ontario
Canada	Sinai Health System-Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	Unity Health Toronto-St Josephs Health Centre	Toronto	Ontario
Canada	Unity Health Toronto-St Michaels Hospital	Toronto	Ontario
Canada	University of Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brain--event related potentials	Electroencephalography	At 4 months corrected age
Other	Brain--power	Electroencephalography	At 4 months corrected age
Other	Brain--connectivity	Electroencephalography	At 4 months corrected age
Other	Weight at follow-up		4 months corrected age
Other	Length at follow-up		4 months corrected age
Other	Head Circumference at follow-up		4 months corrected age
Other	Body composition at follow-up	Skinfolds	4 months corrected age
Other	Body composition at follow-up	Air displacement plethysmography	4 months corrected age
Primary	Cognitive Composite Score	Bayley Scales of Infant and Toddler Development	18-24 months corrected age
Secondary	Language Composite Score	Bayley Scales of Infant and Toddler Development	18-24 months CA
Secondary	Motor Composite Score	Bayley Scales of Infant and Toddler Development	18-24 months CA
Secondary	Weight Gain during the intervention	Change in z-score	Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Secondary	Length gain during the intervention	Change in z-score	Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Secondary	Head circumference gain during the intervention	Change in z-score	Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Secondary	Body composition at the end of the intervention	Skinfolds	36 weeks corrected age
Secondary	Serious Morbidity	Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)	Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first