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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard fortification | Active Comparator |
| |
| Target fortification | Experimental |
| |
| BUN adjustable fortification | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard fortification | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Composite Score | Bayley Scales of Infant and Toddler Development | 18-24 months corrected age |
| Measure | Description | Time Frame |
|---|---|---|
| Language Composite Score | Bayley Scales of Infant and Toddler Development | 18-24 months CA |
| Motor Composite Score | Bayley Scales of Infant and Toddler Development |
| Measure | Description | Time Frame |
|---|---|---|
| Milk Type Received | Type of milk consumed (i.e. parent, donor) | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Energy and Nutrient Intakes of Infants | Energy in kilocalories and nutrient intakes (i.e. macronutrients and micronutrients) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah O'Connor, PhD RD | The Hospital for Sick Children | Principal Investigator |
| Sharon Unger, MD | Sinai Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta | Edmonton | Alberta | T6G 2R3 | Canada | ||
| William Osler Health System-Brampton Civic Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41047263 | Background | Beggs MR, Pichardo D, Chrzaniecki A, Kotsopoulos K, Bishara R, Ng E, Tomlinson C, Campbell D, Vaz S, Kiss A, Unger S, O'Connor DL. MaxiMoM InForM: individualised fortification of human milk for very low birthweight infants- protocol of a three-arm randomised clinical trial. BMJ Open. 2025 Oct 5;15(10):e105609. doi: 10.1136/bmjopen-2025-105609. |
| Label | URL |
|---|---|
| MaxiMoM InForM protocol | View source |
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| Target fortification | Other | 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 | Other | 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. |
|
| 18-24 months CA |
| Weight Gain during the intervention | Change in z-score | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Length gain during the intervention | Change in z-score | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Head circumference gain during the intervention | Change in z-score | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Body composition at the end of the intervention | Skinfolds | 36 weeks corrected age |
| 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 |
| Health Economics | Total cost incurred for in-hospital care | Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Weight at follow-up | z score | 4 months corrected age |
| Length at follow-up | z score | 4 months corrected age |
| Head Circumference at follow-up | z score | 4 months corrected age |
| Body composition at follow-up (approximated) | Skinfolds | 4 months corrected age |
| Body composition at follow-up (direct measurement) | Air displacement plethysmography | 4 months corrected age |
| Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first |
| Maternal Diet During Lactation | Data on maternal diet during the first month of the intervention using the Canadian Diet History Questionnaire II | Study Day 35±3 |
| Brampton |
| Ontario |
| L6R 3J7 |
| Canada |
| William Osler Health System-Etobicoke General Hospital | Etobicoke | Ontario | M9V 1R8 | Canada |
| Markham Stouffville Hospital | Markham | Ontario | L3P 7P3 | Canada |
| Trillium Health Partners-Missisauga Hospital | Mississauga | Ontario | L5B 1B8 | Canada |
| Trillium Health Partners-Credit Valley Hospital | Mississauga | Ontario | L5M 2N1 | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | L3Y 2P9 | Canada |
| North York General Hospital | North York | Ontario | M2K 1E1 | Canada |
| Humber River Hospital | North York | Ontario | M3M 0B2 | Canada |
| Lakeridge Health | Oshawa | Ontario | L1G 2B9 | Canada |
| Mackenzie Health | Richmond Hill | Ontario | L4C 4Z3 | Canada |
| Scarborough Health Network-Centenary Hospital | Scarborough Village | Ontario | M1E 4B9 | Canada |
| Scarborough Health Network-General Hospital | Scarborough Village | Ontario | M1P 2V5 | Canada |
| Michael Garron Hospital | Toronto | Ontario | M4C 3E7 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Unity Health Toronto-St Michaels Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Sinai Health System-Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| University of Toronto | Toronto | Ontario | M5S 1A1 | Canada |
| Unity Health Toronto-St Josephs Health Centre | Toronto | Ontario | M6R 1B5 | Canada |