RecruitingNot ApplicableNCT05308134

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

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


Sponsor

The Hospital for Sick Children

Enrollment

615 participants

Start Date

Nov 11, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Max Age: 21 Days

Inclusion Criteria3

  • ≤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 Criteria5

  • 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.

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Interventions

OTHERStandard 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.

OTHERTarget 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.

OTHERBUN 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(20)

University of Alberta

Edmonton, Alberta, Canada

William Osler Health System-Brampton Civic Hospital

Brampton, Ontario, Canada

William Osler Health System-Etobicoke General Hospital

Etobicoke, Ontario, Canada

Markham Stouffville Hospital

Markham, Ontario, Canada

Trillium Health Partners-Missisauga Hospital

Mississauga, Ontario, Canada

Trillium Health Partners-Credit Valley Hospital

Mississauga, Ontario, Canada

Southlake Regional Health Centre

Newmarket, Ontario, Canada

North York General Hospital

North York, Ontario, Canada

Humber River Hospital

North York, Ontario, Canada

Lakeridge Health

Oshawa, Ontario, Canada

Mackenzie Health

Richmond Hill, Ontario, Canada

Scarborough Health Network-Centenary Hospital

Scarborough Village, Ontario, Canada

Scarborough Health Network-General Hospital

Scarborough Village, Ontario, Canada

Michael Garron Hospital

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Unity Health Toronto-St Michaels Hospital

Toronto, Ontario, Canada

Sinai Health System-Mount Sinai Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

University of Toronto

Toronto, Ontario, Canada

Unity Health Toronto-St Josephs Health Centre

Toronto, Ontario, Canada

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NCT05308134


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