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| ID | Type | Description | Link |
|---|---|---|---|
| MOP-136964 | Other Grant/Funding Number | Canadian Institutes of Health Research (CIHR) |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| Laval University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHA-rich algal oil | Experimental | 1200mg DHA per day |
|
| Placebo | Placebo Comparator | No supplementation in DHA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Mortality is defined as death from any cause. | until 36 weeks PMA |
| Bronchopulmonary Dysplasia (BPD) | Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Supplemental Oxygen | Defined as need for supplemental oxygen (mL/min flow or FiO2) | at 36 weeks PMA |
| Duration of supplemental oxygen or respiratory support | Defined as cumulative days on supplemental oxygen or respiratory support |
Inclusion Criteria:
Exclusion Criteria:
MOTHERS
INFANTS
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Royal Alexander Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33231656 | Result | 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. | |
| 34728723 | Result | 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. |
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| 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. |
|
|
| at 36 weeks PMA |
| Mild, moderate and severe BPD | Defined according to the severity-based National Institute of Child Health & Development (NICHD) criteria | at 36 weeks PMA |
| Necrotizing enterocolitis stage 2 or greater | According to Bell criteria | until first discharge home or 40 weeks PMA |
| Any intraventricular hemorrhage and severe grade III or IV | According to Papile's classification; Screening is performed as routine care; | from randomization until discharge home or 40 weeks PMA |
| Periventricular leucomalacia | Screening is performed as routine care | until discharge home or 40 weeks PMA |
| Sepsis | Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days) | until discharge home or 40 weeks PMA |
| Retinopathy of prematurity (any or threshold) | According to the assessment by ophthalmologist, collected in the medical chart | until first discharge home or 40 weeks PMA |
| Patent ductus arterious | Requiring surgical ligation | until first discharge home or 40 weeks PMA |
| Significant cholestasis | Defined as conjugated serum bilirubin ≥34 µmol/L | until first discharge home or 36 weeks PMA |
| Child anthropometry | Weight, length and cranial circumference as routinely measured and collected in the chart | until first discharge home or 36 weeks PMA |
| 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) | at 18-22 months corrected age (CA) |
| until first discharge home or 36 weeks PMA |
| Hospitalization duration | Defined as number of days in hospital | until first discharge home or 40 weeks PMA |
| Cerebral palsy | will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System | at 18-22 months CA |
| Child anthropometry | Weight, length and cranial circumference | at 18-22 months CA |
| Deafness | Hearing tests will be performed by audiologists according to standard practice | until 18-22 months CA |
| Blindness (yes/no), visual acuity +/- strabismus | According to ophthalmologist or orthoptist examination | until 18-22 months CA |
| Death since 40weeks | Any cause | from first discharge or 40 weeks PMA until 18-22 months CA |
| Number of hospital readmissions | Assessment by standardized interview | From first discharge until 18-22 months CA |
| Respiratory morbidities | Physical examination will be performed by a pediatrician and a standardized general health questionnaire (including respiratory health outcomes) will be completed. Respiratory health outcomes will include respiratory symptoms, hospital admissions for respiratory deteriorations, use of inhaled therapies. | until 18-22 months CA |
| Maternal Satisfaction | Assessment by a questionnaire | at 36 weeks PMA |
| Maternal significant episodes of bleeding requiring treatment or hospitalization until 4 weeks post intervention | Assessment by standardized interview | from date of randomization up to 40 weeks PMA |
| Acceptability of a study at 8 years of age involving brain magnetic resonance imaging (MRI) | Semistructured interviews framed using the theoretical domains framework will be conducted to identify potential barriers and facilitators that may influence participation in a follow-up study with brain MRI at 8 years of age. A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Child health-related quality of life | Assessed by the Pediatric Quality of Life Inventory (PedsQL). A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Behavioral problems | Assessed by the Total Difficulties scores, Externalizing and Internalizing scores of the Strengths and Difficulties Questionnaire. A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Executive function | Assessed by the Global executive composite score of the Behavior Rating Inventory of Executive Function - Preschool. A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Global developmental delay | Assessed by the 5 developmental areas of the Ages and Stages Questionnaire. A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Exposure and impact of the COVID-19 pandemic | Impact on the home environment, quality of life, development and behavioral and executive functioning. A subsample of n=194 children will be eligible to participate if they have not died or withdrawn from the trial and if they were born and enrolled at the following centres:
| at 60 months CA |
| Edmonton |
| Alberta |
| T5H 3V9 |
| Canada |
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
| Children's and Women's Health Centre of British Columbia | Vancouver | British Columbia | V6H 3V4 | Canada |
| Victoria General Hospital | Victoria | British Columbia | V8R 1J8 | Canada |
| St Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Health Sciences Centre | Winnipeg | Manitoba | R3A 1R9 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Kingston Health Science Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| CHU Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Jewish General Centre | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Center, Glen Site, Montreal Children's Hospital | Montreal | Quebec | H4A 3J1 | 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 |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| 35413719 | Result | 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. |
| 35403244 | Result | 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. |
| 37452341 | Result | 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. |
| 37268036 | Result | 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. |
| 39396702 | Result | 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. |
| 35652296 | Derived | 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. |
| 35508343 | 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. |
| 32662862 | 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. |
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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