AzTrials
AzTrials

Bronchopulmonary DysplasiaPhase 3MOBYDIckNCT02371460

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

A Phase 3 study testing DHA-rich algal oil in people with Bronchopulmonary Dysplasia and Child Development, run by CHU de Quebec-Universite Laval at 16 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Read more about this study

Who is it for?
Ages 16 years and older, women only
What is being tested?
DHA-rich algal oil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
461 participants
Where
16 sitesCanada
Study dates
23 Jun 2015to 7 Jul 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age more than or equal to 16 years
  • Pre-term delivery (230/7- 286/7 weeks gestation)
  • No contraindication to breastfeeding
  • Subject intends to provide own breast milk to infant
  • Randomization before or at 72 hours post delivery

Who cannot join

  • MOTHERS
  • Mother is taking > 250 mg of daily DHA supplementation for last 3 months
  • 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)
  • Inability to comprehend and comply with study requirements
  • Participation in this study in a previous pregnancy
  • INFANTS
  • Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)
  • 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)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Canada16 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Royal Alexander Hospital

    Edmonton, Alberta, T5H 3V9

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

  • Kingston Health Science Centre

    Kingston, Ontario, K7L 2V7

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Jewish General Centre

    Montreal, Quebec, H3T 1E2

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

    Montreal, Quebec, H4A 3J1

  • Royal Columbian Hospital

    New Westminster, British Columbia, V3L 3W7

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

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

    Québec, Quebec, G1V 4G2

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

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

    Vancouver, British Columbia, V6H 3V4

  • Victoria General Hospital

    Victoria, British Columbia, V8R 1J8

  • St Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

About this study

Official title: Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)

The aim of this randomized controlled trial is to determine whether docosahexaenoic acid (or DHA, an omega-3 lipid) supplementation in lactating mothers providing breast-milk to their infant born below 29 0/7 weeks of gestational age (GA) improves BPD-free survival at 36 weeks post-menstrual age (PMA). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Read the detailed description

Every year in Canada, 1500 babies who are born early (prematurely) develop a serious lung disease called bronchopulmonary dysplasia (BPD). BPD causes major health problems in these infants, especially in their early childhood. In most situations, breast-milk is the ideal source of nutrition for growth and development of premature babies. However, diets of Canadian mothers are generally deficient in omega-3 lipids (essential fats), resulting in lower protection from these omega-3 lipids in mother's milk-fed infants. Previous research has shown that giving DHA to mothers of premature babies is safe both for the mother and for their baby, and is an efficient way of helping babies meet their dietary requirements from breast-milk. Furthermore, this previous research also suggests that this intervention may reduce the risk of BPD in premature babies receiving breast-milk.

Being tested
DHA-rich algal oil, Placebo
Keywords
Neonatal Prematurity, Omega-3 Fatty Acids, Breastfeeding
Medical subject headings
Bronchopulmonary Dysplasia, Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHA-rich algal oilDietary supplement

    Also called DHA group

    Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA.

  • PlaceboCombination product

    Also called Placebo group

    Mothers will receive a placebo capsule three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA.

Study groups in NCT02371460
Study groupRoleWhat they receive
DHA-rich algal oilExperimental1200mg DHA per day
Receives: Dietary Supplement: DHA-rich algal oil
PlaceboPlacebo comparatorNo supplementation in DHA
Receives: Combination Product: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BPD-free survival

    Defined as (1- combined rate of mortality and BPD in survivors). Mortality is defined as death from any cause between randomization and 36 weeks PMA. Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks

    Measured: at 36 weeks PMA

Secondary outcomes (12)

  1. Mortality

    Mortality is defined as death from any cause.

    Measured: until 36 weeks PMA

  2. Bronchopulmonary Dysplasia (BPD)

    Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks

    Measured: at 36 weeks PMA

  3. Mild, moderate and severe BPD

    Defined according to the severity-based National Institute of Child Health \& Development (NICHD) criteria

    Measured: at 36 weeks PMA

  4. Necrotizing enterocolitis stage 2 or greater

    According to Bell criteria

    Measured: until first discharge home or 40 weeks PMA

  5. Any intraventricular hemorrhage and severe grade III or IV

    According to Papile's classification; Screening is performed as routine care;

    Measured: from randomization until discharge home or 40 weeks PMA

  6. Periventricular leucomalacia

    Screening is performed as routine care

    Measured: until discharge home or 40 weeks PMA

  7. Sepsis

    Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)

    Measured: until discharge home or 40 weeks PMA

  8. Retinopathy of prematurity (any or threshold)

    According to the assessment by ophthalmologist, collected in the medical chart

    Measured: until first discharge home or 40 weeks PMA

  9. Patent ductus arterious

    Requiring surgical ligation

    Measured: until first discharge home or 40 weeks PMA

  10. Significant cholestasis

    Defined as conjugated serum bilirubin ≥34 µmol/L

    Measured: until first discharge home or 36 weeks PMA

  11. Child anthropometry

    Weight, length and cranial circumference as routinely measured and collected in the chart

    Measured: until first discharge home or 36 weeks PMA

  12. Neuro-development

    Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III)

    Measured: at 18-22 months corrected age (CA)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study start23 Jun 2015
  3. Primary completion25 Apr 2019
  4. Study completion7 Jul 2023

Why it stopped: Recruitment was prematurely terminated by the DSMB due to concern of harm for future participants based on interim data favoring the placebo group, findings from the N3RO trial, and the very low probability of benefit from DHA supplementation

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
461 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02371460
Sponsor's protocol ID
2015-2144, B14-09-2144-21
Other IDs
MOP-136964
Acronym
MOBYDIck
Status last verified
Aug 2026
First submitted
19 Feb 2015
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Marc I, Julien P, Lavoie PM. Maternal Docosahexaenoic Acid Supplementation and Bronchopulmonary Dysplasia in Infants-Reply. JAMA. 2020 Nov 24;324(20):2105. doi: 10.1001/jama.2020.19410. No abstract available.

    PubMed 33231656

  • Fougere H, Bilodeau JF, Lavoie PM, Mohamed I, Rudkowska I, Pronovost E, Simonyan D, Berthiaume L, Guillot M, Piedboeuf B, Julien P, Marc I. Docosahexaenoic acid-rich algae oil supplementation on breast milk fatty acid profile of mothers who delivered prematurely: a randomized clinical trial. Sci Rep. 2021 Nov 2;11(1):21492. doi: 10.1038/s41598-021-01017-8.

    PubMed 34728723

  • Angoa G, Pronovost E, Ndiaye ABKT, Lavoie PM, Lemyre B, Mohamed I, Simonyan D, Qureshi M, Afifi J, Yusuf K, Series T, Guillot M, Piedboeuf B, Fraser WD, Nuyt AM, Masse B, Lacaze-Masmonteil T, Marc I. Effect of Maternal Docosahexaenoic Acid Supplementation on Very Preterm Infant Growth: Secondary Outcome of a Randomized Clinical Trial. Neonatology. 2022;119(3):377-385. doi: 10.1159/000524147. Epub 2022 Apr 12.

    PubMed 35413719

  • Ndiaye ABKT, Mohamed I, Pronovost E, Angoa G, Piedboeuf B, Lemyre B, Afifi J, Qureshi M, Series T, Guillot M, Simonyan D, Yusuf K, Lavoie PM, Fraser WD, Masse B, Nuyt AM, Lacaze-Masmonteil T, Marc I. Use of SMOF lipid emulsion in very preterm infants does not affect the incidence of bronchopulmonary dysplasia-free survival. JPEN J Parenter Enteral Nutr. 2022 Nov;46(8):1892-1902. doi: 10.1002/jpen.2380. Epub 2022 May 8.

    PubMed 35403244

  • Fougere H, Greffard K, Guillot M, Rudkowska I, Pronovost E, Simonyan D, Marc I, Bilodeau JF. Docosahexaenoic acid-rich algae oil supplementation in mothers of preterm infants is associated with a modification in breast milk oxylipins profile. Lipids Health Dis. 2023 Jul 14;22(1):103. doi: 10.1186/s12944-023-01870-8.

    PubMed 37452341

  • Series T, Guillot M, Angoa G, Pronovost E, Ndiaye ABKT, Mohamed I, Simonyan D, Lavoie PM, Synnes A, Marc I; MOBYDIck trial group. Does Growth Velocity Affect Associations between Birth Weight and Neurodevelopment for Infants Born Very Preterm? J Pediatr. 2023 Sep;260:113531. doi: 10.1016/j.jpeds.2023.113531. Epub 2023 Jun 1.

    PubMed 37268036

  • Paquet SP, Pronovost E, Simonyan D, Caouette G, Matte-Gagne C, Olivier F, Bartholomew J, Morin A, Mohamed I, Marc I, Guillot M. Maternal high-dose docosahexaenoic acid supplementation and neurodevelopment at 5 Years of preterm children. Clin Nutr ESPEN. 2024 Dec;64:253-262. doi: 10.1016/j.clnesp.2024.09.029. Epub 2024 Oct 11.

    PubMed 39396702

  • Guillot M, Synnes A, Pronovost E, Qureshi M, Daboval T, Caouette G, Olivier F, Bartholomew J, Mohamed I, Masse E, Afifi J, Hendson L, Lemyre B, Luu TM, Strueby L, Cieslak Z, Yusuf K, Pelligra G, Ducruet T, Ndiaye ABKT, Angoa G, Series T, Piedboeuf B, Nuyt AM, Fraser W, Masse B, Lacaze-Masmonteil T, Lavoie PM, Marc I. Maternal High-Dose DHA Supplementation and Neurodevelopment at 18-22 Months of Preterm Children. Pediatrics. 2022 Jul 1;150(1):e2021055819. doi: 10.1542/peds.2021-055819.

    PubMed 35652296

  • Guillot M, Robitaille CA, Turner L, Pronovost E, Caouette G, Matte-Gagne C, Olivier F, Bartholomew J, Masse E, Morin A, Mohamed I, Marc I. Effects of maternal docosahexaenoic acid supplementation on brain development and neurodevelopmental outcomes of breastfed preterm neonates: protocol for a follow-up at preschool age of a randomised clinical trial (MOBYDIckPS). BMJ Open. 2022 May 4;12(5):e057482. doi: 10.1136/bmjopen-2021-057482.

    PubMed 35508343

  • Marc I, Piedboeuf B, Lacaze-Masmonteil T, Fraser W, Masse B, Mohamed I, Qureshi M, Afifi J, Lemyre B, Caouette G, Bartholomew J, Nuyt AM, Julien P, Synnes A, Lucas M, Perreault T, Strueby L, Cieslak Z, Yusuf K, Pelligra G, Masse E, Larsen B, de Cabo C, Ruth C, Khurshid F, Lavoie PM. Effect of Maternal Docosahexaenoic Acid Supplementation on Bronchopulmonary Dysplasia-Free Survival in Breastfed Preterm Infants: A Randomized Clinical Trial. JAMA. 2020 Jul 14;324(2):157-167. doi: 10.1001/jama.2020.8896.

    PubMed 32662862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DHA-rich algal oil in people with Bronchopulmonary Dysplasia and Child Development, run by CHU de Quebec-Universite Laval at 16 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Recruitment was prematurely terminated by the DSMB due to concern of harm for future participants based on interim data favoring the placebo group, findings from the N3RO trial, and the very low probability of benefit from DHA supplementation). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BPD-free survival (time frame: at 36 weeks PMA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02371460, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in