Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-31 @ 11:56 PM
Study NCT ID:
NCT02371460
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-24
First Post:
2015-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2015-02-19', 'studyFirstSubmitQcDate': '2015-02-19', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Supplemental Oxygen', 'timeFrame': 'at 36 weeks PMA', 'description': 'Defined as need for supplemental oxygen (mL/min flow or FiO2)'}, {'measure': 'Duration of supplemental oxygen or respiratory support', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Defined as cumulative days on supplemental oxygen or respiratory support'}, {'measure': 'Hospitalization duration', 'timeFrame': 'until first discharge home or 40 weeks PMA', 'description': 'Defined as number of days in hospital'}, {'measure': 'Cerebral palsy', 'timeFrame': 'at 18-22 months CA', 'description': 'will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System'}, {'measure': 'Child anthropometry', 'timeFrame': 'at 18-22 months CA', 'description': 'Weight, length and cranial circumference'}, {'measure': 'Deafness', 'timeFrame': 'until 18-22 months CA', 'description': 'Hearing tests will be performed by audiologists according to standard practice'}, {'measure': 'Blindness (yes/no), visual acuity +/- strabismus', 'timeFrame': 'until 18-22 months CA', 'description': 'According to ophthalmologist or orthoptist examination'}, {'measure': 'Death since 40weeks', 'timeFrame': 'from first discharge or 40 weeks PMA until 18-22 months CA', 'description': 'Any cause'}, {'measure': 'Number of hospital readmissions', 'timeFrame': 'From first discharge until 18-22 months CA', 'description': 'Assessment by standardized interview'}, {'measure': 'Respiratory morbidities', 'timeFrame': 'until 18-22 months CA', 'description': '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.'}, {'measure': 'Maternal Satisfaction', 'timeFrame': 'at 36 weeks PMA', 'description': 'Assessment by a questionnaire'}, {'measure': 'Maternal significant episodes of bleeding requiring treatment or hospitalization until 4 weeks post intervention', 'timeFrame': 'from date of randomization up to 40 weeks PMA', 'description': 'Assessment by standardized interview'}, {'measure': 'Acceptability of a study at 8 years of age involving brain magnetic resonance imaging (MRI)', 'timeFrame': 'at 60 months CA', 'description': "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.\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}, {'measure': 'Child health-related quality of life', 'timeFrame': 'at 60 months CA', 'description': "Assessed by the Pediatric Quality of Life Inventory (PedsQL).\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}, {'measure': 'Behavioral problems', 'timeFrame': 'at 60 months CA', 'description': "Assessed by the Total Difficulties scores, Externalizing and Internalizing scores of the Strengths and Difficulties Questionnaire.\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}, {'measure': 'Executive function', 'timeFrame': 'at 60 months CA', 'description': "Assessed by the Global executive composite score of the Behavior Rating Inventory of Executive Function - Preschool.\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}, {'measure': 'Global developmental delay', 'timeFrame': 'at 60 months CA', 'description': "Assessed by the 5 developmental areas of the Ages and Stages Questionnaire.\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}, {'measure': 'Exposure and impact of the COVID-19 pandemic', 'timeFrame': 'at 60 months CA', 'description': "Impact on the home environment, quality of life, development and behavioral and executive functioning.\n\nA 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:\n\n1. CHU de Québec-Université Laval\n2. Centre Hospitalier Universitaire de Sherbrooke, CHUS\n3. CHU Sainte-Justine\n4. Jewish General Centre\n5. McGill University Health Center, Glen Site, Montreal Children's Hospital"}], 'primaryOutcomes': [{'measure': 'BPD-free survival', 'timeFrame': 'at 36 weeks PMA', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'until 36 weeks PMA', 'description': 'Mortality is defined as death from any cause.'}, {'measure': 'Bronchopulmonary Dysplasia (BPD)', 'timeFrame': 'at 36 weeks PMA', 'description': 'Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks'}, {'measure': 'Mild, moderate and severe BPD', 'timeFrame': 'at 36 weeks PMA', 'description': 'Defined according to the severity-based National Institute of Child Health \\& Development (NICHD) criteria'}, {'measure': 'Necrotizing enterocolitis stage 2 or greater', 'timeFrame': 'until first discharge home or 40 weeks PMA', 'description': 'According to Bell criteria'}, {'measure': 'Any intraventricular hemorrhage and severe grade III or IV', 'timeFrame': 'from randomization until discharge home or 40 weeks PMA', 'description': "According to Papile's classification; Screening is performed as routine care;"}, {'measure': 'Periventricular leucomalacia', 'timeFrame': 'until discharge home or 40 weeks PMA', 'description': 'Screening is performed as routine care'}, {'measure': 'Sepsis', 'timeFrame': 'until discharge home or 40 weeks PMA', 'description': 'Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)'}, {'measure': 'Retinopathy of prematurity (any or threshold)', 'timeFrame': 'until first discharge home or 40 weeks PMA', 'description': 'According to the assessment by ophthalmologist, collected in the medical chart'}, {'measure': 'Patent ductus arterious', 'timeFrame': 'until first discharge home or 40 weeks PMA', 'description': 'Requiring surgical ligation'}, {'measure': 'Significant cholestasis', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Defined as conjugated serum bilirubin ≥34 µmol/L'}, {'measure': 'Child anthropometry', 'timeFrame': 'until first discharge home or 36 weeks PMA', 'description': 'Weight, length and cranial circumference as routinely measured and collected in the chart'}, {'measure': 'Neuro-development', 'timeFrame': 'at 18-22 months corrected age (CA)', 'description': "Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III)"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Neonatal Prematurity', 'Omega-3 Fatty Acids', 'Breastfeeding'], 'conditions': ['Bronchopulmonary Dysplasia', 'Child Development', 'Neonatal and Perinatal Conditions']}, 'referencesModule': {'references': [{'pmid': '33231656', 'type': 'BACKGROUND', 'citation': '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': '34728723', 'type': 'BACKGROUND', 'citation': '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': '35413719', 'type': 'BACKGROUND', 'citation': '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': '35403244', 'type': 'BACKGROUND', 'citation': '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': '37452341', 'type': 'BACKGROUND', 'citation': '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': '37268036', 'type': 'BACKGROUND', 'citation': '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': '39396702', 'type': 'BACKGROUND', 'citation': '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': '35652296', 'type': 'DERIVED', 'citation': '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': '35508343', 'type': 'DERIVED', 'citation': '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': '32662862', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age more than or equal to 16 years\n2. Pre-term delivery (230/7- 286/7 weeks gestation)\n3. No contraindication to breastfeeding\n4. Subject intends to provide own breast milk to infant\n5. Randomization before or at 72 hours post delivery\n\nExclusion Criteria:\n\nMOTHERS\n\n1. Mother is taking \\> 250 mg of daily DHA supplementation for last 3 months\n2. 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)\n3. Inability to comprehend and comply with study requirements\n4. Participation in this study in a previous pregnancy\n\nINFANTS\n\n1. Significant congenital malformations in the infant (or one of the infants in case of multiple pregnancy)\n2. 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)'}, 'identificationModule': {'nctId': 'NCT02371460', 'acronym': 'MOBYDIck', 'briefTitle': 'Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'CHU de Quebec-Universite Laval'}, 'officialTitle': 'Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)', 'orgStudyIdInfo': {'id': '2015-2144, B14-09-2144-21'}, 'secondaryIdInfos': [{'id': 'MOP-136964', 'type': 'OTHER_GRANT', 'domain': 'Canadian Institutes of Health Research (CIHR)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DHA-rich algal oil', 'description': '1200mg DHA per day', 'interventionNames': ['Dietary Supplement: DHA-rich algal oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'No supplementation in DHA', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'DHA-rich algal oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['DHA group'], 'description': '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.', 'armGroupLabels': ['DHA-rich algal oil']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Placebo group'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 2T9', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Medical Centre', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexander Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V3L 3W7', 'city': 'New Westminster', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Royal Columbian Hospital', 'geoPoint': {'lat': 49.20678, 'lon': -122.91092}}, {'zip': 'V6H 3V4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "Children's and Women's Health Centre of British Columbia", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V8R 1J8', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Victoria General Hospital', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'R2H 2A6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'St Boniface General Hospital', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Health Sciences Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K7L 2V7', 'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Kingston Health Science Centre', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'H3T 1C5', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Centre', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H4A 3J1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "McGill University Health Center, Glen Site, Montreal Children's Hospital", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Québec-Université Laval, Centre Mère Enfant Soleil du CHUL', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Isabelle Marc, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Québec, Université Laval'}, {'name': 'Pascal Lavoie, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's and Women's Health Centre of BC, University of British Columbia"}, {'name': 'Benoît Mâsse, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Sainte-Justine, Université de Montreal'}, {'name': 'Thierry Lacaze, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Eastern Ontario, University of Ottawa"}, {'name': 'Anne-Monique Nuyt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Sainte-Justine, Université de Montreal'}, {'name': 'William Fraser, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHU de Quebec-Universite Laval', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'Laval University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}