The N3RO trial: A randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants

N3RO Investigative Team

Research output: Contribution to journalArticleResearchpeer-review

Abstract

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. 

Trial registration: Australia and New Zealand Clinical Trial Registry: ACTRN12612000503820. Registered 09 May 2012.

Original languageEnglish
Article number72
Pages (from-to)1 - 9
Number of pages9
JournalBMC Pediatrics
Volume16
Issue number1
DOIs
Publication statusPublished - 1 Jun 2016

Keywords

  • Bronchopulmonary dysplasia
  • Docosahexaenoic acid
  • Infant
  • N-3 long chain polyunsaturated fatty acids
  • Preterm

Cite this

@article{d7400469506149af8112c708c58a3ddd,
title = "The N3RO trial: A randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants",
abstract = "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. Trial registration: Australia and New Zealand Clinical Trial Registry: ACTRN12612000503820. Registered 09 May 2012.",
keywords = "Bronchopulmonary dysplasia, Docosahexaenoic acid, Infant, N-3 long chain polyunsaturated fatty acids, Preterm",
author = "Collins, {Carmel T.} and Gibson, {Robert A.} and Maria Makrides and McPhee, {Andrew J.} and Sullivan, {Thomas R.} and Davis, {Peter G.} and Marta Thio and Karen Simmer and Rajadurai, {Victor S.} and Kenneth Tan and {N3RO Investigative Team}",
year = "2016",
month = "6",
day = "1",
doi = "10.1186/s12887-016-0611-0",
language = "English",
volume = "16",
pages = "1 -- 9",
journal = "BMC Pediatrics",
issn = "1471-2431",
publisher = "Springer-Verlag London Ltd.",
number = "1",

}

The N3RO trial : A randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants. / N3RO Investigative Team.

In: BMC Pediatrics, Vol. 16, No. 1, 72, 01.06.2016, p. 1 - 9.

Research output: Contribution to journalArticleResearchpeer-review

TY - JOUR

T1 - The N3RO trial

T2 - A randomised controlled trial of docosahexaenoic acid to reduce bronchopulmonary dysplasia in preterm infants

AU - Collins, Carmel T.

AU - Gibson, Robert A.

AU - Makrides, Maria

AU - McPhee, Andrew J.

AU - Sullivan, Thomas R.

AU - Davis, Peter G.

AU - Thio, Marta

AU - Simmer, Karen

AU - Rajadurai, Victor S.

AU - Tan, Kenneth

AU - N3RO Investigative Team

PY - 2016/6/1

Y1 - 2016/6/1

N2 - 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. Trial registration: Australia and New Zealand Clinical Trial Registry: ACTRN12612000503820. Registered 09 May 2012.

AB - 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. Trial registration: Australia and New Zealand Clinical Trial Registry: ACTRN12612000503820. Registered 09 May 2012.

KW - Bronchopulmonary dysplasia

KW - Docosahexaenoic acid

KW - Infant

KW - N-3 long chain polyunsaturated fatty acids

KW - Preterm

UR - http://www.scopus.com/inward/record.url?scp=84971530424&partnerID=8YFLogxK

U2 - 10.1186/s12887-016-0611-0

DO - 10.1186/s12887-016-0611-0

M3 - Article

VL - 16

SP - 1

EP - 9

JO - BMC Pediatrics

JF - BMC Pediatrics

SN - 1471-2431

IS - 1

M1 - 72

ER -