N-3 fatty acids for improvement in Respiratory Outcomes - the N3RO Trial
South Australian Health and Medical Research Institute (SAHMRI)Dataset description
In preterm infants born at less than 29 weeks gestation is an emulsion containing a higher amount of docosahexaenoic acid (DHA) more effective than an emulsion with no additional DHA in reducing the incidence of bronchopulmonary dysplasia at 36 weeks post menstrual age?Identifiers
Source Study
Trial name (public)
Can omega 3 fatty acids improve respiratory outcomes in preterm infants?Trial acronym
N3RO (n-3 fatty acids for improvement of respiratory outcomes)
Trial ID
ACTRN12612000503820
Purpose
Prevention
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Dr Jacqueline Gould
Brief Summary
The purpose of this study is to determine the degree to which Docosahexaenoic acid (DHA) supplementation reduces the incidence of bronchopulomonary dysplasia (BPD), as assessed by the requirement for supplemental oxygen and/or assisted ventilation at 36 weeks post menstrual age.
Key Inclusion Criteria
Born at less than 29 weeks gestational age Within 3 days of commencing enteral feeds Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the infant’s behalf
Key Exclusion Criteria
Infants who have a major congenital or chromosomal abnormality will be excluded from the study Women providing breast milk who are taking supplements providing >250 mg DHA per day and do not wish to stop taking supplements. Infants participating in another fatty acid study. Infants receiving intravenous lipid emulsions containing fish oil given as early lipid parenteral nutrition support.
Can healthy volunteers participate?
No
Population
Sample Size 1273
Min. age 0 No limit
Max. age 0 No limit
Sex Both males and females
Condition category Bronchopulmonary dysplasia , Preterm infants
Condition code Reproductive Health and Childbirth , Respiratory
Intervention
Intervention code Prevention
Tuna oil emulsion containing 120 mg/mL of DHA to provide 60 mg/kg/day of DHA (0.17 ml/kg three times a day). The intervention will be given enterally within 72 hours of the first enteral feed and continue until 36 weeks post menstrual age or discharge home (whichever occurs first).
Comparison
Control group Placebo
Soy oil emulsion with no additional DHA given at 0.17 mL/kg three times a day. The control will be given enterally within 72 hours of the first enteral feed and continue until 36 weeks post menstrual age or discharge home (whichever occurs first).
Outcomes
Outcome: The primary outcome bronchopulmonary dysplasia will be defined on a physiologic basis that combines oxygen and ventilation support with an assessment of saturation.Timepoint: The diagnosis of bronchopulmonary dysplasia will be determined at 36 weeks postmenstrual age (36 weeks and 0 days to 36 weeks and 6 days inclusive) or day of discharge home, whichever occurs first.
Outcome: Intelligence, as reflected by a Full Scale Intelligence Quotient score. Overall intelligence will be assessed by a psychologist using the Wechsler Preschool and Primary Scale of Intelligence - Fourth Edition (WPPSI-IV) Australian and New Zealand Standardised Edition. A pre-defined subsample of n=707 children will be eligible to participate in the cognitive assessment. Children will be eligible if they have not died or withdrawn from the trial, and if were born and enrol .... Read more
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Individual participant data, including data dictionaries, may be shared after deidentification on reasonable request.
When will data be available?
Data will be available for sharing from 01/01/2024, with no planned end date.
Available to whom?
De-identified data may be made available to researchers.
Available for what types of analyses?
Data will be available for scientifically and methodologically sound analyses.