Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

NCT02371460 | Active Not Recruiting Phase 3 DMC

• 2 other identifiers: 2015-2144, B14-09-2144-21MOP-136964
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 16

Brief 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). Half of participants will receive docosahexaenoic acid (DHA), an omega-3 lipid, while the other half will receive a placebo.

Conditions

Bronchopulmonary Dysplasia; Child Development; Neonatal and Perinatal Conditions

Keywords

Neonatal Prematurity; Omega-3 Fatty Acids; Breastfeeding

Outcome Measures

Primary Outcomes (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

  at 36 weeks PMA

Secondary Outcomes (12)

• Mortality

  until 36 weeks PMA

• Bronchopulmonary Dysplasia (BPD)

  at 36 weeks PMA

• Mild, moderate and severe BPD

  at 36 weeks PMA

• Necrotizing enterocolitis stage 2 or greater

  until first discharge home or 40 weeks PMA

• Any intraventricular hemorrhage and severe grade III or IV

  from randomization until discharge home or 40 weeks PMA

Other Outcomes (18)

• Supplemental Oxygen

  at 36 weeks PMA

• Duration of supplemental oxygen or respiratory support

  until first discharge home or 36 weeks PMA

• Hospitalization duration

  until first discharge home or 40 weeks PMA

Study Arms (2)

DHA-rich algal oil

EXPERIMENTAL

1200mg DHA per day

Dietary Supplement: DHA-rich algal oil

Placebo

PLACEBO COMPARATOR

No supplementation in DHA

Combination Product: Placebo

Interventions

DHA-rich algal oil DIETARY_SUPPLEMENT

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.

Also known as: DHA group

DHA-rich algal oil

Placebo COMBINATION_PRODUCT

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.

Also known as: Placebo group

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laval University: collaborator

Study Sites (16)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Alexander Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Location

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

Vancouver, British Columbia, V6H 3V4, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

St Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Kingston Health Science Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Jewish General Centre

Montreal, Quebec, H3T 1E2, Canada

Location

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

Montreal, Quebec, H4A 3J1, Canada

Location

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

Québec, Quebec, G1V 4G2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (10)

• 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.

  PMID: 33231656 BACKGROUND

• 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.

  PMID: 34728723 BACKGROUND

• 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.

  PMID: 35413719 BACKGROUND

• 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.

  PMID: 35403244 BACKGROUND

• 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.

  PMID: 37452341 BACKGROUND

• 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.

  PMID: 37268036 BACKGROUND

• 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.

  PMID: 39396702 BACKGROUND

• 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.

  PMID: 35652296 DERIVED

• 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.

  PMID: 35508343 DERIVED

• 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.

  PMID: 32662862 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Breast Feeding

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Feeding Behavior; Behavior

Study Officials

• Isabelle Marc, MD, PhD

  CHU de Québec, Université Laval

  PRINCIPAL INVESTIGATOR

• Pascal Lavoie, MD, PhD

  Children's and Women's Health Centre of BC, University of British Columbia

  PRINCIPAL INVESTIGATOR

• Benoît Mâsse, PhD

  CHU Sainte-Justine, Université de Montreal

  PRINCIPAL INVESTIGATOR

• Thierry Lacaze, MD, PhD

  Children's Hospital of Eastern Ontario, University of Ottawa

  PRINCIPAL INVESTIGATOR

• Anne-Monique Nuyt, MD, PhD

  CHU Sainte-Justine, Université de Montreal

  PRINCIPAL INVESTIGATOR

• William Fraser, MD, MSc

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: February 25, 2015
• Study Start: June 23, 2015
• Primary Completion: April 25, 2019
• Study Completion: March 1, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (16)