NCT Number: NCT02371460
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.
This study is active but is not currently recruiting participants.
16 year and older
Female
Interventional
Phase 3
Foothills Medical Centre, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
MOTHERS
INFANTS
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 names: DHA group
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 names: Placebo group
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
Time frame: until 36 weeks PMA
Mortality is defined as death from any cause.
Time frame: at 36 weeks PMA
Physiological BPD is defined as the need for oxygen and/or ventilation at 36 weeks
Time frame: at 36 weeks PMA
Defined according to the severity-based National Institute of Child Health & Development (NICHD) criteria
Time frame: until first discharge home or 40 weeks PMA
According to Bell criteria
Time frame: from randomization until discharge home or 40 weeks PMA
According to Papile's classification; Screening is performed as routine care;
Time frame: until discharge home or 40 weeks PMA
Screening is performed as routine care
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)
Time frame: until first discharge home or 40 weeks PMA
According to the assessment by ophthalmologist, collected in the medical chart
Time frame: until first discharge home or 40 weeks PMA
Requiring surgical ligation
Time frame: until first discharge home or 36 weeks PMA
Defined as conjugated serum bilirubin ≥34 µmol/L
Time frame: until first discharge home or 36 weeks PMA
Weight, length and cranial circumference as routinely measured and collected in the chart
Time frame: at 18-22 months corrected age (CA)
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 36 weeks PMA
Defined as need for supplemental oxygen (mL/min flow or FiO2)
Time frame: until first discharge home or 36 weeks PMA
Defined as cumulative days on supplemental oxygen or respiratory support
Time frame: until first discharge home or 40 weeks PMA
Defined as number of days in hospital
Time frame: at 18-22 months CA
will be ascertained using standard definitions and severity classified using the Gross Motor Function Classification System
Time frame: at 18-22 months CA
Weight, length and cranial circumference
Time frame: until 18-22 months CA
Hearing tests will be performed by audiologists according to standard practice
Time frame: until 18-22 months CA
According to ophthalmologist or orthoptist examination
Time frame: from first discharge or 40 weeks PMA until 18-22 months CA
Any cause
Time frame: From first discharge until 18-22 months CA
Assessment by standardized interview
Time frame: until 18-22 months CA
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: at 36 weeks PMA
Assessment by a questionnaire
Time frame: from date of randomization up to 40 weeks PMA
Assessment by standardized interview
Time frame: at 60 months CA
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:
Time frame: at 60 months CA
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:
Time frame: at 60 months CA
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:
Time frame: at 60 months CA
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:
Time frame: at 60 months CA
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:
Time frame: at 60 months CA
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 Quebec-Universite Laval
Other
Maternal Omega-3 Supplementation to Reduce BronchopulmonarY Dysplasia in Very Preterm Infants (MOBYDIck Trial)
Acronym: MOBYDIck
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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