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

NARecruitingINTERVENTIONAL
Enrollment

615

Participants

Timeline

Start Date

November 11, 2021

Primary Completion Date

July 1, 2026

Study Completion Date

July 1, 2026

Conditions
Very Low Birth Weight Infant
Interventions
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.

OTHER

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.

OTHER

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.

Trial Locations (20)

T6G 2R3

ACTIVE_NOT_RECRUITING

University of Alberta, Edmonton

L6R 3J7

ACTIVE_NOT_RECRUITING

William Osler Health System-Brampton Civic Hospital, Brampton

M9V 1R8

ACTIVE_NOT_RECRUITING

William Osler Health System-Etobicoke General Hospital, Etobicoke

L3P 7P3

ACTIVE_NOT_RECRUITING

Markham Stouffville Hospital, Markham

L5B 1B8

ACTIVE_NOT_RECRUITING

Trillium Health Partners-Missisauga Hospital, Mississauga

L5M 2N1

ACTIVE_NOT_RECRUITING

Trillium Health Partners-Credit Valley Hospital, Mississauga

L3Y 2P9

ACTIVE_NOT_RECRUITING

Southlake Regional Health Centre, Newmarket

M2K 1E1

ACTIVE_NOT_RECRUITING

North York General Hospital, North York

M3M 0B2

ACTIVE_NOT_RECRUITING

Humber River Hospital, North York

L1G 2B9

ACTIVE_NOT_RECRUITING

Lakeridge Health, Oshawa

L4C 4Z3

ACTIVE_NOT_RECRUITING

Mackenzie Health, Richmond Hill

M1E 4B9

ACTIVE_NOT_RECRUITING

Scarborough Health Network-Centenary Hospital, Scarborough Village

M1P 2V5

ACTIVE_NOT_RECRUITING

Scarborough Health Network-General Hospital, Scarborough Village

M4C 3E7

ACTIVE_NOT_RECRUITING

Michael Garron Hospital, Toronto

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre, Toronto

M5B 1W8

ACTIVE_NOT_RECRUITING

Unity Health Toronto-St Michaels Hospital, Toronto

M5G 1X5

RECRUITING

Sinai Health System-Mount Sinai Hospital, Toronto

M5G 1X8

ACTIVE_NOT_RECRUITING

The Hospital for Sick Children, Toronto

M5S 1A1

ACTIVE_NOT_RECRUITING

University of Toronto, Toronto

M6R 1B5

ACTIVE_NOT_RECRUITING

Unity Health Toronto-St Josephs Health Centre, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER