Back to results

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

Primary Purpose

Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions

Status

Active

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

DHA-rich algal oil

Placebo

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Neonatal Prematurity, Omega-3 Fatty Acids, Breastfeeding

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)

Sites / Locations

Foothills Medical Centre
Royal Alexander Hospital
Royal Columbian Hospital
Children's and Women's Health Centre of British Columbia
Victoria General Hospital
St Boniface General Hospital
Health Sciences Centre
IWK Health Centre
Kingston Health Science Centre
Children's Hospital of Eastern Ontario
McGill University Health Center, Glen Site, Montreal Children's Hospital
CHU Sainte-Justine
Jewish General Centre
Centre Hospitalier Universitaire de Sherbrooke
Royal University Hospital
CHU de Québec-Université Laval, Centre Mère Enfant Soleil du CHUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

DHA-rich algal oil

Placebo

Arm Description

1200mg DHA per day

No supplementation in DHA

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mortality

Mortality is defined as death from any cause.

Bronchopulmonary Dysplasia (BPD)

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

Mild, moderate and severe BPD

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

Necrotizing enterocolitis stage 2 or greater

According to Bell criteria

Any intraventricular hemorrhage and severe grade III or IV

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

Periventricular leucomalacia

Screening is performed as routine care

Sepsis

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

Retinopathy of prematurity (any or threshold)

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

Patent ductus arterious

Requiring surgical ligation

Significant cholestasis

Defined as conjugated serum bilirubin ≥34 µmol/L

Child anthropometry

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

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)

Full Information

NCT ID

NCT02371460

First Posted

February 19, 2015

Last Updated

August 30, 2023

Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR), Laval University

1. Study Identification

Unique Protocol Identification Number

NCT02371460

Brief Title

Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia

Acronym

MOBYDIck

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 23, 2015 (Actual)

Primary Completion Date

April 25, 2019 (Actual)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

Collaborators

Canadian Institutes of Health Research (CIHR), Laval University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia, Child Development, Neonatal and Perinatal Conditions

Keywords

Neonatal Prematurity, Omega-3 Fatty Acids, Breastfeeding

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DHA-rich algal oil

Arm Type

Experimental

Arm Description

1200mg DHA per day

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

No supplementation in DHA

Intervention Type

Dietary Supplement

Intervention Name(s)

DHA-rich algal oil

Other Intervention Name(s)

DHA group

Intervention 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.

Intervention Type

Combination Product

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo group

Intervention 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.

Primary Outcome Measure Information:

Title

BPD-free survival

Description

Time Frame

at 36 weeks PMA

Secondary Outcome Measure Information:

Title

Mortality

Description

Mortality is defined as death from any cause.

Time Frame

until 36 weeks PMA

Title

Bronchopulmonary Dysplasia (BPD)

Description

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

Time Frame

at 36 weeks PMA

Title

Mild, moderate and severe BPD

Description

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

Time Frame

at 36 weeks PMA

Title

Necrotizing enterocolitis stage 2 or greater

Description

According to Bell criteria

Time Frame

until first discharge home or 40 weeks PMA

Title

Any intraventricular hemorrhage and severe grade III or IV

Description

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

Time Frame

from randomization until discharge home or 40 weeks PMA

Title

Periventricular leucomalacia

Description

Screening is performed as routine care

Time Frame

until discharge home or 40 weeks PMA

Title

Sepsis

Description

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

Time Frame

until discharge home or 40 weeks PMA

Title

Retinopathy of prematurity (any or threshold)

Description

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

Time Frame

until first discharge home or 40 weeks PMA

Title

Patent ductus arterious

Description

Requiring surgical ligation

Time Frame

until first discharge home or 40 weeks PMA

Title

Significant cholestasis

Description

Defined as conjugated serum bilirubin ≥34 µmol/L

Time Frame

until first discharge home or 36 weeks PMA

Title

Child anthropometry

Description

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

Time Frame

until first discharge home or 36 weeks PMA

Title

Neuro-development

Description

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

Time Frame

at 18-22 months corrected age (CA)

Other Pre-specified Outcome Measures:

Title

Supplemental Oxygen

Description

Defined as need for supplemental oxygen (mL/min flow or FiO2)

Time Frame

at 36 weeks PMA

Title

Duration of supplemental oxygen or respiratory support

Description

Defined as cumulative days on supplemental oxygen or respiratory support

Time Frame

until first discharge home or 36 weeks PMA

Title

Hospitalization duration

Description

Defined as number of days in hospital

Time Frame

until first discharge home or 40 weeks PMA

Title

Cerebral palsy

Description

will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System

Time Frame

at 18-22 months CA

Title

Child anthropometry

Description

Weight, length and cranial circumference

Time Frame

at 18-22 months CA

Title

Deafness

Description

Hearing tests will be performed by audiologists according to standard practice

Time Frame

until 18-22 months CA

Title

Blindness (yes/no), visual acuity +/- strabismus

Description

According to ophthalmologist or orthoptist examination

Time Frame

until 18-22 months CA

Title

Death since 40weeks

Description

Any cause

Time Frame

from first discharge or 40 weeks PMA until 18-22 months CA

Title

Number of hospital readmissions

Description

Assessment by standardized interview

Time Frame

From first discharge until 18-22 months CA

Title

Respiratory morbidities

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.

Time Frame

until 18-22 months CA

Title

Maternal Satisfaction

Description

Assessment by a questionnaire

Time Frame

at 36 weeks PMA

Title

Maternal significant episodes of bleeding requiring treatment or hospitalization until 4 weeks post intervention

Description

Assessment by standardized interview

Time Frame

from date of randomization up to 40 weeks PMA

Title

Acceptability of a study at 8 years of age involving brain magnetic resonance imaging (MRI)

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. 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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

Title

Child health-related quality of life

Description

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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

Title

Behavioral problems

Description

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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

Title

Executive function

Description

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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

Title

Global developmental delay

Description

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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

Title

Exposure and impact of the COVID-19 pandemic

Description

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: CHU de Québec-Université Laval Centre Hospitalier Universitaire de Sherbrooke, CHUS CHU Sainte-Justine Jewish General Centre McGill University Health Center, Glen Site, Montreal Children's Hospital

Time Frame

at 60 months CA

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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)

Overall Study Officials: