Maelstrom Research Staging | MOBYDIck_Mothers_14_days

MOBYDIck_Mothers_14_days_postnatal

Networks -

Variables -

Associated study MOBYDIck Contingency Table

Population

MOBYDIck - Mothers

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

Newborns

Twins

Countries

Canada

Ethnic Origin

Health Status

Other Criteria

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

Specific population

Specific Population

Clinic patients

Supplementary Information

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: Mothers randomized in the DHA group: 232 participants
Mothers randomized in the placebo group: 229 participants

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Data Collection Event

MOBYDIck - Mothers - 14 days postnatal follow-up

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 last dose, and expected number of capsules, was collected by research staff and pharmacists. Information related to the trial, such as protocol deviations and reasons for missed visits or study exits, was collected. Information on maternal concomitant medication and maternal adverse events (severity, adverse reaction, related treatments) was collected from maternal interviews and medical records. Levels of DHA and other fatty acids were measured in breast milk samples collected on postnatal day 14.

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Collected Dataset / MOBYDIck_Mothers_14_days_postnatal

MOBYDIck_Mothers_14_days_postnatal

Population

MOBYDIck - Mothers

Data Collection Event

MOBYDIck - Mothers - 14 days postnatal follow-up

Files

Variables Classifications