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?
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Source Study

Trial acronym

N3RO (n-3 fatty acids for improvement of respiratory outcomes)

Trial ID





Not Applicable


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?




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 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).


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).


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 ....
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Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?


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.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see