Maternal Omega-3 Supplementation to Reduce Bronchopulmonary Dysplasia in Very Preterm Infants
Networks
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Datasets
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Variables
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The objective of the MOBYDIck trial, a superiority, placebo-controlled randomized clinical trial, is to determine whether, compared with a placebo, maternal docosahexaenoic acid (DHA) supplementation during the neonatal period improves bronchopulmonary dysplasia-free survival in breastfed infants born before 29 weeks of gestation from 16 Canadian neonatal intensive care units.
- Start Year
- 2015
- End Year
- 2020
- Supplementary Information
- A list of additional papers of interest is available at https://clinicaltrials.gov/study/NCT02371460
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Design
- Study design
- Clinical trial
- Follow Up
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**Mothers**
Following randomization, participants were followed at their infants’ 14 days, 35 days, 36 weeks’ postmenstrual age (PMA) and 40 weeks’ PMA. **Infants**
Following randomization of their mothers, participants were continuously monitored until 40 weeks’ PMA and at 18-22 months’ corrected age (CA). - Supplementary Information
- Mothers were randomized within 72h after delivery of their premature infant(s) in a 1:1 ratio to DHA or placebo according to computer-generated random lists of treatment allocations, using variable permuted block sizes of 4 and 6, with a separate list for each center. Infants from multiple births were assigned to the same group because randomization was performed at the mother level. Site pharmacists were provided with a blinded randomization list of identification numbers unique to each infant. Treatment bottles were identical, dispensed by site pharmacists who were blinded to the treatment allocation, and sealed and labeled with the participant's name, protocol number, study ID, and kit number for traceability. Interim analyses and DSMB reports were prepared by biostatisticians not directly involved with the trial. All investigators, research staff, clinicians, pharmacists, the main trial statistician, and participants at each trial site, as well as the data coordinating center, were blinded to treatment allocation throughout the entire trial and data analysis.
Marker Paper
Marc I, Piedboeuf B, Lacaze-Masmonteil T, et al. 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. PMID: 32662862; PMCID: PMC7361648.
PUBMED 32662862
Recruitment
- Recruitment Target
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- Individuals
Number of Participants
- Number of Participants
- 989
- Number of Participants with Biological Samples
- 389
- Supplementary Information
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Mothers: 461 participants
Infants: 528 participants
Maternal breast milk: 389 samples
Access
Availability of data and biosamples
| Possible Access to Data | |
| Possible Access to Biosamples | |
| Other |
Availability of access information
By contacting the study representative
Sector of research
| Possible Access to Data | Possible Access to Biosamples | |
|---|---|---|
| Investigators from the public sector | ||
| Investigators from the private sector | ||
| Investigators from not-for-profit organization |
Authors will examine request from any groups for future collaboration after an inter-institutional agreement, ethics, and all legal process.
Transfer
| Possible Access to Data | Possible Access to Biosamples | |
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| Can leave the study facility | ||
| Can leave the country |
Anonymized data without the possibility of re-identification.
Cost
| Possible Access to Data | Not yet defined |
| Possible Access to Biosamples | Not yet defined |
Authors will examine request from any groups for future collaboration after an inter-institutional agreement, ethics, and all legal process.
Cost reduction for co-analyses
| Possible Access to Data | |
| Possible Access to Biosamples |
Supplementary Information
Authors will examine request from any groups for future collaboration after an inter-institutional agreement, ethics, and all legal process.
Timeline
Populations
The population is composed of mothers who delivered prematurely between 23 0/7 and 28 6/7 weeks of gestation who were randomized to receive either a placebo or a supplementation providing 1.2g of DHA per day.
Selection Criteria
- Minimum age
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16
- Newborns
- Twins
- Countries
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- Canada
- Ethnic Origin
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- Health Status
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- Other Criteria
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Inclusions:
* Participant did not present contraindications for breastfeeding.
* Participant intended to provide their own breast milk to their infant.
* Participant was within 72 hours of delivery at the time of randomization.
Exclusions: * Participant took more than 250 mg/d of DHA during the 3 months before enrollment. * Infant presenting a major congenital or chromosomal abnormality. * Participant did not plan to breastfeed infant * Participant or their infant(s) enrolled in another clinical trial. * Infant died before eligibility assessment could be completed.
Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Clinic patients
- Supplementary Information
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Mothers who delivered prematurely between 23 0/7 and 28 6/7 weeks of gestation were screened for eligibility, provided consent, and were enrolled with their infant(s) by site investigators or delegates upon admission of infants to the neonatal intensive care unit.
Number of Participants
- Number of Participants
- 461
- Number of Participants with Biological Samples
- 389
- Supplementary Information about selection criteria
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Mothers randomized in the DHA group: 232 participants
Mothers randomized in the placebo group: 229 participants
Data Collection Events
| # | Name | Description | Start | End |
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| 0 |
MOBYDIck - Mothers - Baseline
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Information related to the trial, such as consent and eligibility review, randomization confirmation, protocol deviations, and other administrative data, was collected. Socio-demographic ... | 2015-06 | 2018-04 |
| 1 |
MOBYDIck - Mothers - 14 days postnatal follow-up
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Information on maternal adherence to the intervention, such as the ratio of capsules taken, days without capsules, number of capsules returned, date of first dose, timing of first dose, date of ... | 2015-07 | 2018-04 |
| 2 |
MOBYDIck - Mothers - 35 days post-delivery
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Information on maternal adherence to the intervention, such as the ratio of capsules taken, days without capsules, number of capsules returned, date of first dose, timing of first dose, date of ... | 2015-07 | 2018-05 |
| 3 |
MOBYDIck - Mothers - 36 weeks' PMA
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Information on maternal adherence to the intervention, such as the ratio of capsules taken, days without capsules, number of capsules returned, date of first dose, timing of first dose, date of ... | 2015-08 | 2018-06 |
| 4 |
MOBYDIck - Mothers - 40 weeks' PMA
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Information related to the trial, such as protocol deviations, reasons for missed visits, or study exits, was collected. Information on maternal concomitant medication and maternal adverse events ... | 2015-09 | 2018-07 |
The population is composed of the infants delivered prematurely between 23 0/7 and 28 6/7 weeks of gestation whose mothers were randomized to receive either a placebo or a supplementation providing 1.2g of DHA per day.
Selection Criteria
- Newborns
- Twins
- Countries
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- Canada
- Ethnic Origin
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- Health Status
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Recruitment
- Sources of recruitment
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- Specific population
- Specific Population
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- Clinic patients
- Supplementary Information
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Participants were recruited through their participant mother.
Number of Participants
- Number of Participants
- 528
- Number of Participants with Biological Samples
- Supplementary Information about selection criteria
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Infants in the DHA group: 273 participants
Infants in the placebo group: 255 participants
Data Collection Events
| # | Name | Description | Start | End |
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| 0 |
MOBYDIck - Infants - Birth to 40 weeks' PMA
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Information related to the trial such as protocol deviations and reason for study exit was collected. Blood pressure, heart rate, and blood pH were also measured within 0 to 12 hours of age. ... | 2015-06 | 2018-07 |
| 2 |
MOBYDIck - Infants - 36 weeks' PMA
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Relevant information including FiO2, flow, NPPV, O2 saturation and data on cardiorespiratory events (number of events, apnea, bradycardia, desaturation) were also collected before, during, and ... | 2015-08 | 2018-06 |
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MOBYDIck - Infants - 18-22 months' CA
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Information on the family, home environment (second-hand smoke exposition, nutrition and language at home) and parent perception of their child health were collected through a questionnaire ... | 2017-03 | 2020-05 |
Classifications
- Socio-demographic and economic characteristics
- Lifestyle and behaviours
- Birth, pregnancy and reproductive health history
- Perception of health, quality of life, development and functional limitations
- Diseases
- Symptoms and signs
- Medication and supplements
- Non-pharmacological interventions
- Health and community care services utilization
- Death
- Physical measures and assessments
- Laboratory measures
- Cognition, personality and psychological measures and assessments
- Life events, life plans, beliefs and values
- Preschool, school and work life
- Social environment and relationships
- Physical environment
- Administrative information
- Cognitive functioning
- Personality
- Psychological distress and emotions
- Other psychological measures and assessments
- Perception of health
- Quality of life
- Life course development
- Functional limitations
- Other perception of health, quality of life and functional limitation-related information
Socio-demographic and economic characteristics
Age/birthdate
Sex/gender
Twin
Marital/partner status
Family and household structure
Education
Residence
Ethnicity, race and religion
Language
Labour force and retirement
Income, possessions, and benefits
Lifestyle and behaviours
Tobacco
Alcohol
Drugs
Nutrition
Breastfeeding
Birth, pregnancy and reproductive health history
Puberty, menstruation, menopause and andropause
Pregnancy, delivery and birth
Fertility and sexual health
Perception of health, quality of life, development and functional limitations
Perception of health
Life course development
Functional limitations
Use of assistive devices
Diseases
Certain infectious and parasitic diseases (A00-B99)
Endocrine, nutritional and metabolic diseases (E00-E90)
Mental and behavioural disorders (F00-F99)
Diseases of the nervous system (G00-G99)
Diseases of the eye and adnexa (H00-H59)
Diseases of the ear and mastoid process (H60-H95)
Diseases of the circulatory system (I00-I99)
Diseases of the respiratory system (J00-J99)
Diseases of the digestive system (K00-K93)
Diseases of the skin and subcutaneous tissue (L00-L99)
Pregnancy, childbirth and the puerperium (O00-O9A)
Certain conditions originating in the perinatal period (P00-P96)
Congenital malformations, deformations and chromosomal abnormalities (Q00-Q99)
Injury, poisoning and certain other consequences of external causes (S00-T98)
Diseases without precise specification or falling into multiple categories
Symptoms and signs
Symptoms and signs involving the digestive system and abdomen (R10-R19)
Symptoms and signs involving cognition, perception, emotional state and behaviour (R40-R46)
General symptoms and signs (R50-R69)
Symptoms related to multiple categories
Medication and supplements
Medication and supplement intake
Posology and protocol of administration
Non-pharmacological interventions
Surgical interventions
Radiological interventions
Educational and health promotion interventions
Laboratory diagnosis interventions
Other and unspecified non-pharmacological interventions
Health and community care services utilization
Visits to health professionals
Hospitalizations
Community and social care
Death
Vital status
Cause of death
Other end of life or death-related information
Physical measures and assessments
Anthropometry
Circulation and respiration
Brain and nerves
Other physical measures and assessments
Laboratory measures
Hematology
Biochemistry
Microbiology
Other laboratory measures
Cognition, personality and psychological measures and assessments
Cognitive functioning
Personality
Preschool, school and work life
Preschool life
Social environment and relationships
Social support
Physical environment
Chemical exposure
Administrative information
Identifiers
Date and time-related information
Questionnaire and interview-related information
Physical and cognitive measure and biosample-related information
Data and sample collection center-related information
Other administrative information
Cognitive functioning
Gross Motor Function Classification System
Personality
Child Behavior Checklist
Life course development
Bayley Scales of Infant and Toddler Development