Omega-3 Fatty Acids for Preterm Infants Harmonisation Protocol
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
Overview
- Harmonization Initiative
- N3PI-HI
- Harmonization Protocol
- N3PI-HP
- Version
- 1
- Number of Variables
Design
- Type
- Quantitative
- Approach
- Retrospective
- Procedures
- Harmonized data is generated by a central harmonization team (with the collaboration of studies).
- Infrastructure
- Harmonized data must remain on study servers, but request for pooled data will be evaluated by studies investigators.
- Participant Inclusion
- All study participants are eligible for inclusion.
- Number of Participants
- 1,801
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
Participating Studies
| Acronym | Name | Study design | Countries |
|---|
Harmonization Initiatives Included
| Acronym | Name |
|---|
Harmonization
Scroll over each status icon to get more details on the corresponding harmonization results:
- Complete - study-specific variable is the same as DataSchema variable (status detail = identical) or needs transformation to generate DataSchema variable (status detail = compatible) or unknown (status detail = unknown)
- Partial - categorical study-specific variable (status detail = proximate) or other types (status detail = tentative) could generate DataSchema variable but with loss of information or unknown (status detail = unknown)
- Impossible - study does not collect DataSchema variable (status detail = unavailable) or cannot be used to generate DataSchema variable (status detail = incompatible) or unknown (status detail = unknown)
- Not Applicable - harmonization status is not relevant
- Undetermined - harmonization status not determined
Variables Content Summary
Areas of Information Collected
No Areas of Information Collected
No Scales Collected
Areas of Information Collected per Dataset
No Areas of Information Collected
No Scales Collected
Last Update: 2024-06-04T10:22:58.445