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

Sponsor
The Hospital for Sick Children (Other)
Overall Status
Recruiting
CT.gov ID
NCT05308134
Collaborator
(none)
615
Enrollment
20
Locations
3
Arms
55.6
Anticipated Duration (Months)
30.8
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Standard fortification
  • Other: Target fortification
  • Other: BUN adjustable fortification
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
615 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
MaxiMoM: Individualized Fortification of Human Milk for Infants Born ≤ 1250 g; a Three Arm Randomized Clinical Trial
Actual Study Start Date :
Nov 11, 2021
Anticipated Primary Completion Date :
Jul 1, 2026
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard fortification

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.
Experimental: Target fortification

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.
Experimental: BUN adjustable fortification

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.

Outcome Measures

Primary Outcome Measures

  1. Cognitive Composite Score [18-24 months corrected age]

    Bayley Scales of Infant and Toddler Development

Secondary Outcome Measures

  1. Language Composite Score [18-24 months CA]

    Bayley Scales of Infant and Toddler Development

  2. Motor Composite Score [18-24 months CA]

    Bayley Scales of Infant and Toddler Development

  3. Weight Gain during the intervention [Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first]

    Change in z-score

  4. Length gain during the intervention [Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first]

    Change in z-score

  5. Head circumference gain during the intervention [Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first]

    Change in z-score

  6. Body composition at the end of the intervention [36 weeks corrected age]

    Skinfolds

  7. Serious Morbidity [Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first]

    Composite of death, NEC, late onset sepsis, chronic lung disease or severe retinopathy of prematurity (ROP)

Other Outcome Measures

  1. Brain--event related potentials [At 4 months corrected age]

    Electroencephalography

  2. Brain--power [At 4 months corrected age]

    Electroencephalography

  3. Brain--connectivity [At 4 months corrected age]

    Electroencephalography

  4. Weight at follow-up [4 months corrected age]

  5. Length at follow-up [4 months corrected age]

  6. Head Circumference at follow-up [4 months corrected age]

  7. Body composition at follow-up [4 months corrected age]

    Skinfolds

  8. Body composition at follow-up [4 months corrected age]

    Air displacement plethysmography

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 21 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alberta Edmonton Alberta Canada T6G 2R3
2 William Osler Health System-Brampton Civic Hospital Brampton Ontario Canada L6R 3J7
3 William Osler Health System-Etobicoke General Hospital Etobicoke Ontario Canada M9V 1R8
4 Markham Stouffville Hospital Markham Ontario Canada L3P 7P3
5 Trillium Health Partners-Missisauga Hospital Mississauga Ontario Canada L5B 1B8
6 Trillium Health Partners-Credit Valley Hospital Mississauga Ontario Canada L5M 2N1
7 Southlake Regional Health Centre Newmarket Ontario Canada L3Y 2P9
8 North York General Hospital North York Ontario Canada M2K 1E1
9 Humber River Hospital North York Ontario Canada M3M 0B2
10 Lakeridge Health Oshawa Ontario Canada L1G 2B9
11 Mackenzie Health Richmond Hill Ontario Canada L4C 4Z3
12 Scarborough Health Network-Centenary Hospital Scarborough Ontario Canada M1E 4B9
13 Scarborough Health Network-General Hospital Scarborough Ontario Canada M1P 2V5
14 Michael Garron Hospital Toronto Ontario Canada M4C 3E7
15 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5
16 Unity Health Toronto-St Michaels Hospital Toronto Ontario Canada M5B 1W8
17 Sinai Health System-Mount Sinai Hospital Toronto Ontario Canada M5G 1X5
18 The Hospital for Sick Children Toronto Ontario Canada M5G 1X8
19 University of Toronto Toronto Ontario Canada M5S 1A1
20 Unity Health Toronto-St Josephs Health Centre Toronto Ontario Canada M6R 1B5

Sponsors and Collaborators

  • The Hospital for Sick Children

Investigators

  • Principal Investigator: Deborah O'Connor, PhD RD, The Hospital for Sick Children
  • Principal Investigator: Sharon Unger, MD, Sinai Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Deborah O'Connor, Senior Associate Scientist, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT05308134
Other Study ID Numbers:
  • 1861
First Posted:
Apr 1, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Birth Weight

Study Results

No Results Posted as of Apr 11, 2022