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Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia (MOBYDIck)

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ClinicalTrials.gov Identifier: NCT02371460
Recruitment Status : Active, not recruiting
First Posted : February 25, 2015
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laval University
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Child Development Neonatal and Perinatal Conditions Dietary Supplement: DHA-rich algal oil Dietary Supplement: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)
Study Start Date : May 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: DHA-rich algal oil
1200mg DHA per day
Dietary Supplement: DHA-rich algal oil
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.
Other Name: DHA group

Placebo Comparator: Placebo
No supplementation in DHA
Dietary Supplement: Placebo
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.
Other Name: Placebo group




Primary Outcome Measures :
  1. BPD-free survival [ Time Frame: at 36 weeks PMA ]
    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


Secondary Outcome Measures :
  1. Mortality [ Time Frame: until 36 weeks PMA ]
    Mortality is defined as death from any cause.

  2. Bronchopulmonary Dysplasia (BPD) [ Time Frame: at 36 weeks PMA ]
    Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks

  3. Mild, moderate and severe BPD [ Time Frame: at 36 weeks PMA ]
    Defined according to the severity-based National Institute of Child Health & Development (NICHD) criteria

  4. Necrotizing enterocolitis stage 2 or greater [ Time Frame: until first discharge home or 40 weeks PMA ]
    According to Bell criteria

  5. Any intraventricular hemorrhage and severe grade III or IV [ Time Frame: from randomization until discharge home or 40 weeks PMA ]
    According to Papile's classification; Screening is performed as routine care;

  6. Periventricular leucomalacia [ Time Frame: until discharge home or 40 weeks PMA ]
    Screening is performed as routine care

  7. Sepsis [ Time Frame: until discharge home or 40 weeks PMA ]
    Defined as culture-positive (blood or cerebrospinal fluid) and/or clinical infection (with antibiotics ≥5 days)

  8. Retinopathy of prematurity (any or threshold) [ Time Frame: until first discharge home or 40 weeks PMA ]
    According to the assessment by ophthalmologist, collected in the medical chart

  9. Patent ductus arterious [ Time Frame: until first discharge home or 40 weeks PMA ]
    Requiring surgical ligation

  10. Significant cholestasis [ Time Frame: until first discharge home or 36 weeks PMA ]
    Defined as conjugated serum bilirubin ≥34 µmol/L

  11. Child anthropometry [ Time Frame: until first discharge home or 36 weeks PMA ]
    Weight, length and cranial circumference as routinely measured and collected in the chart

  12. Neuro-development [ Time Frame: at 18-22 corrected age (CA) months ]
    Defined as mean cognitive, language and motor composite scores of the Bayley Scale of Infant and Toddler Development's third edition (Bayley-III)


Other Outcome Measures:
  1. Supplemental Oxygen [ Time Frame: at 36 weeks PMA ]
    Defined as need for supplemental oxygen (mL/min flow or FiO2)

  2. Duration of supplemental oxygen or respiratory support [ Time Frame: until first discharge home or 36 weeks PMA ]
    Defined as cumulative days on supplemental oxygen or respiratory support

  3. Hospitalization duration [ Time Frame: until first discharge home or 40 weeks PMA ]
    Defined as number of days in hospital

  4. Cerebral palsy [ Time Frame: at 18-22 corrected age (CA) months ]
    will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System

  5. Child anthropometry [ Time Frame: at 18-22 corrected age (CA) months ]
    Weight, length and cranial circumference

  6. Deafness [ Time Frame: until 18-22 corrected age (CA) months ]
    Hearing tests will be performed by audiologists according to standard practice

  7. Blindness (yes/no), visual acuity +/- strabismus [ Time Frame: until 18-22 corrected age (CA) months ]
    According to ophthalmologist or orthoptist examination

  8. Death since 40weeks [ Time Frame: from first discharge or 40 weeks PMA until 18-22 corrected age (CA) months ]
    Any cause

  9. Number of hospital readmissions [ Time Frame: From first discharge until 18-22 corrected age (CA) months ]
    Assessment by standardized interview

  10. Respiratory morbidities [ Time Frame: until 18-22 corrected age (CA) months ]
    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.

  11. Maternal Satisfaction [ Time Frame: at 36 weeks PMA ]
    Assessment by a questionnaire

  12. Maternal significant episodes of bleeding requiring treatment or hospitalization until 4 weeks post intervention [ Time Frame: from date of randomization up to 40 weeks PMA ]
    Assessment by standardized interview



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371460


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Royal Alexander Hospital
Edmonton, Alberta, Canada, T5H 3V9
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada, V6H 3V4
Victoria General Hospital
Victoria, British Columbia, Canada, V8R 1J8
Canada, Manitoba
St Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
Kingston Health Science Centre
Kingston, Ontario, Canada, K7L 2V7
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Canada, Quebec
Jewish General Centre
Montreal, Quebec, Canada, H3T 1E2
McGill University Health Center, Glen Site, Montreal Children's Hospital
Montreal, Quebec, Canada, H4A 3J1
CHU Sainte-Justine
Montréal, Quebec, Canada, H3T 1C5
Centre Hospitalier Universitaire de Sherbrooke, CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
CHU de Quebec, Centre Mère Enfant Soleil du CHUL
Quebec, Canada, G1V 4G2
Sponsors and Collaborators
CHU de Quebec-Universite Laval
Canadian Institutes of Health Research (CIHR)
Laval University
Investigators
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Principal Investigator: Isabelle Marc, MD,PhD CHU de Quebec, Université Laval
Principal Investigator: Pascal Lavoie, MD, PhD Children's and Women's Health Centre of BC, University of British Columbia
Principal Investigator: Mâsse Benoît, 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

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Responsible Party: CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT02371460     History of Changes
Other Study ID Numbers: 2015-2144, B14-09-2144-21
MOP-136964 ( Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR) )
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by CHU de Quebec-Universite Laval:
Neonatal Prematurity
Omega-3 Fatty Acids
Breastfeeding

Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases