Omega-3 Fatty Acids for Preterm Infants Harmonisation Protocol
Networks
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Variables
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The objectives of the Omega-3 Fatty Acids for Preterm Infants Harmonization Protocol were to:
- Generate a harmonized dataset across the Australian (N3RO) and Canadian (MOBYDIck) randomized clinical trials to address the objectives of the Omega-3 Fatty Acids for Preterm Infants Harmonization Initiative;
- Harmonize bronchopulmonary dysplasia outcomes between the trials
- Version
- 1
- Number of Participants
- 1,801
- Approach
- Retrospective
- Type
- Quantitative
- Procedures
- Harmonized data is generated by a central harmonization team (with the collaboration of studies).
- Participant Inclusion
- All study participants are eligible for inclusion.
- Infrastructure
- Harmonized data must remain on study servers, but request for pooled data will be evaluated by studies investigators.
Information Content
The Omega-3 Fatty Acids for Preterm Infants Harmonization Protocol includes data prospectively collected in a population of preterm infants born before 29 weeks of gestation on:
- Maternal sociodemographic characteristics
- Maternal pregnancy and delivery information
- Infant nutritional data and medical treatment
- Infant anthropometrics at 36 weeks' postmenstrual age
- Infant respiratory status at 36 weeks' postmenstrual age
- Infant neonatal outcomes up to 40 weeks' postmenstrual age
Studies Included
| Study | Population | Data Collection Event |
|---|---|---|
| MOBYDIck |
Initiatives Included
Harmonization
- Complete - study-specific variable is the same as DataSchema variable (status detail = identical) or needs transformation to generate DataSchema variable (status detail = compatible)
- Partial - categorical study-specific variable (status detail = proximate) or other types (status detail = tentative) could generate DataSchema variable but with loss of information
- Impossible - study does not collect DataSchema variable (status detail = unavailable) or cannot be used to generate DataSchema variable (status detail = incompatible)
- Undetermined - harmonization status not determined
- Not Applicable - harmonization status is not relevant
| Variable | MOBYDIck |
|---|