The N3RO trial: a randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants < 29 weeks’ gestation

Collins, Carmel T., Gibson, Robert A., Makrides, Maria, McPhee, Andrew J., Sullivan, Thomas R., Davis, Peter G., Thio, Marta, Simmer, Karen, Rajadurai, Victor S., Ryan, Philip, Morris, Scott, Stark, Michael, Travadi, Javeed, Wright, Ian, Tan, Kenneth, Holberton, James, Opie, Gillian, Callander, Ian, Stack, Jacqueline, Shein, Doron, Bellhouse, Sarah, Bolisetty, Srinivas, Lui, Kei, Liley, Helen, Berry, Mary, Harris, Deborah, Chua, Mei Chien, and Agarwal, Pooja (2016) The N3RO trial: a randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants < 29 weeks’ gestation. BMC Pediatrics, 16 (1). 72.

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Background: Bronchopulmonary dysplasia (BPD) is a major cause of mortality and long-term respiratory and neurological morbidity in very preterm infants. While survival rates of very preterm infants have increased over the past two decades there has been no decrease in the rate of BPD in surviving infants. Evidence from animal and human studies has suggested potential benefits of docosahexaenoic acid (DHA), an n-3 long chain polyunsaturated fatty acid, in the prevention of chronic lung disease. This randomised controlled trial aims to determine the effectiveness of supplementary DHA in reducing the rate of BPD in infants less than 29 weeks’ gestation.

Methods/design: This is a multicentre, parallel group, randomised, blinded and controlled trial. Infants born less than 29 weeks’ gestation, within 3 days of first enteral feed and with parent informed consent are eligible to participate. Infants will be randomised to receive an enteral emulsion containing DHA or a control emulsion without DHA. The DHA emulsion will provide 60 mg/kg/day of DHA. The study emulsions will continue to 36 weeks’ postmenstrual age (PMA). The primary outcome is BPD as assessed by the requirement for supplemental oxygen and/or assisted ventilation at 36 weeks’ PMA. Secondary outcomes include the composite of death or BPD; duration of respiratory support and hospitalisation, major neonatal morbidities. The target sample size is 1244 infants (622 per group), which will provide 90 % power to detect a clinically meaningful absolute reduction of 10 % in the incidence of BPD between the DHA and control emulsion (two tailed α =0.05).

Discussion: DHA supplementation has the potential to reduce respiratory morbidity in very preterm infants. This multicentre trial will provide evidence on whether an enteral DHA supplement reduces BPD in very preterm infants.

Item ID: 62803
Item Type: Article (Scholarly Work)
ISSN: 1471-2431
Keywords: Bronchopulmonary dysplasia, Docosahexaenoic acid, Infant, N-3 long chain polyunsaturated fatty acids, Preterm
Copyright Information: © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( applies to the data made available in this article, unless otherwise stated.
Date Deposited: 06 Jul 2022 05:39
FoR Codes: 32 BIOMEDICAL AND CLINICAL SCIENCES > 3213 Paediatrics > 321303 Neonatology @ 100%
SEO Codes: 20 HEALTH > 2005 Specific population health (excl. Indigenous health) > 200506 Neonatal and child health @ 100%
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