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

June 2, 2026 updated by: Deborah O'Connor, The Hospital for Sick Children

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
615

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 3 weeks (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≤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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognitive Composite Score
Time Frame: 18-24 months corrected age
Bayley Scales of Infant and Toddler Development
18-24 months corrected age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Language Composite Score
Time Frame: 18-24 months CA
Bayley Scales of Infant and Toddler Development
18-24 months CA
Motor Composite Score
Time Frame: 18-24 months CA
Bayley Scales of Infant and Toddler Development
18-24 months CA
Weight Gain during the intervention
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Change in z-score
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Length gain during the intervention
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Change in z-score
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Head circumference gain during the intervention
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
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
Time Frame: 36 weeks corrected age
Skinfolds
36 weeks corrected age
Serious Morbidity
Time Frame: 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)
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Health Economics
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
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
Time Frame: 4 months corrected age
z score
4 months corrected age
Length at follow-up
Time Frame: 4 months corrected age
z score
4 months corrected age
Head Circumference at follow-up
Time Frame: 4 months corrected age
z score
4 months corrected age
Body composition at follow-up (approximated)
Time Frame: 4 months corrected age
Skinfolds
4 months corrected age
Body composition at follow-up (direct measurement)
Time Frame: 4 months corrected age
Air displacement plethysmography
4 months corrected age

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Milk Type Received
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
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
Time Frame: Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Energy in kilocalories and nutrient intakes (i.e. macronutrients and micronutrients)
Study Day 1 to 36 weeks corrected age or hospital discharge, whichever occurs first
Maternal Diet During Lactation
Time Frame: Study Day 35±3
Data on maternal diet during the first month of the intervention using the Canadian Diet History Questionnaire II
Study Day 35±3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah O'Connor, PhD RD, The Hospital for Sick Children
  • Principal Investigator: Sharon Unger, MD, Sinai Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1861 (Other Identifier: Ministry of Food and Drug Safety (MFDS))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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