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Could a Mother's Omega-3 supplement shield preterm Babies' lungs?

NCT ID NCT02371460

Prevention Sponsor: CHU de Quebec-Universite Laval 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 13, 2026 · Last updated Aug 14, 2026 · Updated 1 time

Summary

This trial tests whether giving mothers a DHA-rich omega-3 supplement after delivering very preterm (before 29 weeks) could improve their babies' chances of surviving without bronchopulmonary dysplasia, a chronic lung condition. Half the mothers receive DHA capsules, and half receive a placebo, taken three times daily until the baby reaches 36 weeks post-menstrual age. The goal is to see if DHA in breast milk can reduce lung damage and improve outcomes for these fragile infants.

What this could mean

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

Active substance
DHA-rich algal oil (an omega-3 supplement)
What this could lead to
If it works, this could offer a simple way to improve lung health and survival in very preterm infants.
What could go wrong
This is an early-stage test, and results may not confirm a benefit. The supplement is generally safe, but its effect on severe lung disease remains uncertain.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

461 people

The number who actually took part.

Started

Jun 2015

Finished

Jul 2023

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

16 years and older

Sex

Female participants only

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: 1. Age more than or equal to 16 years 2. Pre-term delivery (230/7- 286/7 weeks gestation) 3. No contraindication to breastfeeding 4. Subject intends to provide own breast milk to infant 5. Randomization before or at 72 hours post delivery Exclusion Criteria: MOTHERS 1. Mother is taking \> 250 mg of daily DHA supplementation for last 3 months 2. Mother who is currently enrolled or has participated in another clinical trial in which she had received an investigational drug or intervention within 3 months of the date of randomization (unless approved by the Trial Coordinating Centre) 3. Inability to comprehend and comply with study requirements 4. Participation in this study in a previous pregnancy INFANTS 1. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy) 2. Infant (or one of the infants in case of multiple pregnancy) who is currently enrolled in another clinical trial (unless approved by the Trial Coordinating Centre)

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Conditions

The condition(s) this trial relates to.

Breast Feeding perinatal disease bronchopulmonary dysplasia prevention target

As listed by the trial registrant

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

Bronchopulmonary dysplasia Child development Neonatal and perinatal conditions

Contacts and locations

Locations

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5, Canada

  • CHU de Québec-Université Laval, Centre Mère Enfant Soleil du CHUL

    Québec, Quebec, G1V 4G2, Canada

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1, Canada

  • Children's and Women's Health Centre of British Columbia

    Vancouver, British Columbia, V6H 3V4, Canada

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9, Canada

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8, Canada

  • Jewish General Centre

    Montreal, Quebec, H3T 1E2, Canada

  • Kingston Health Science Centre

    Kingston, Ontario, K7L 2V7, Canada

  • McGill University Health Center, Glen Site, Montreal Children's Hospital

    Montreal, Quebec, H4A 3J1, Canada

  • Royal Alexander Hospital

    Edmonton, Alberta, T5H 3V9, Canada

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7, Canada

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8, Canada

  • St Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6, Canada

  • Victoria General Hospital

    Victoria, British Columbia, V8R 1J8, Canada

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