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Can tailored nutrients in breast milk boost brain development in tiny babies?

NCT ID NCT05308134

Disease control Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests two ways to add extra nutrients to breast milk for very low birth weight infants (≤1250 grams) to help them grow and develop better. About 615 babies will be randomly assigned to receive standard fortification or one of two personalized methods (target or BUN adjustable). Researchers will track growth during hospital stay and measure thinking and language skills at 18-24 months of age.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
human milk fortification (standard, target, or BUN adjustable)
What this could lead to
If successful, this could show that personalized fortification helps very low birth weight infants grow better and have improved brain development.
What could go wrong
This is a large trial but still early-stage evidence. The methods are complex and may not show clear benefits over standard care. Results may not apply to all hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 615 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 21 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Very low birth weight infant

Contacts and locations

Locations

  • Humber River Hospital

    North York, Ontario, M3M 0B2, Canada

  • Lakeridge Health

    Oshawa, Ontario, L1G 2B9, Canada

  • Mackenzie Health

    Richmond Hill, Ontario, L4C 4Z3, Canada

  • Markham Stouffville Hospital

    Markham, Ontario, L3P 7P3, Canada

  • Michael Garron Hospital

    Toronto, Ontario, M4C 3E7, Canada

  • North York General Hospital

    North York, Ontario, M2K 1E1, Canada

  • Scarborough Health Network-Centenary Hospital

    Scarborough Village, Ontario, M1E 4B9, Canada

  • Scarborough Health Network-General Hospital

    Scarborough Village, Ontario, M1P 2V5, Canada

  • Sinai Health System-Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Southlake Regional Health Centre

    Newmarket, Ontario, L3Y 2P9, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8, Canada

  • Trillium Health Partners-Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1, Canada

  • Trillium Health Partners-Missisauga Hospital

    Mississauga, Ontario, L5B 1B8, Canada

  • Unity Health Toronto-St Josephs Health Centre

    Toronto, Ontario, M6R 1B5, Canada

  • Unity Health Toronto-St Michaels Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • University of Alberta

    Edmonton, Alberta, T6G 2R3, Canada

  • University of Toronto

    Toronto, Ontario, M5S 1A1, Canada

  • William Osler Health System-Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7, Canada

  • William Osler Health System-Etobicoke General Hospital

    Etobicoke, Ontario, M9V 1R8, Canada

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