Evidence map›Paper›PMID 27250120›Full record

Trial reportBMC pediatrics2016

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

Carmel T Collins, Robert A Gibson, Maria Makrides, Andrew J McPhee, Thomas R Sullivan, Peter G Davis, Marta Thio, Karen Simmer, Victor S Rajadurai, N3RO Investigative Team

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.

  1. New-generation intravenous fat emulsions and bronchopulmonary dysplasia in preterm infants: a systematic review and meta-analysis.Journal of perinatology : official journal of the California Perinatal Association · 2020
    Pooled it
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  5. Article
  6. A ComparativeMolecules (Basel, Switzerland) · 2024
    Article
  7. Article
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  10. Observational
  11. Review
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  14. Docosahexaenoic acid and the preterm infant.Maternal health, neonatology and perinatology · 2017
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 3 countries.

Carmel T CollinsWomen's and Children's Health Research Institute, North Adelaide, South Australia, Australia. carmel.collins@sa.gov.au.
Robert A GibsonHealthy Mother's, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Maria MakridesWomen's and Children's Health Research Institute, North Adelaide, South Australia, Australia.
Andrew J McPheeHealthy Mother's, Babies and Children, South Australian Health and Medical Research Institute, Adelaide, South Australia, Australia.
Thomas R SullivanSchool of Public Health, The University of Adelaide, Adelaide, South Australia, Australia.
Peter G DavisNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia.
Marta ThioNewborn Research Centre, The Royal Women's Hospital, Melbourne, VIC, Australia.
Karen SimmerCentre of Neonatal Research and Education, The University of Western Australia, Perth, WA, Australia.
Victor S RajaduraiDepartment Neonatology, KK Women's and Children's Hospital, Singapore, Singapore.
N3RO Investigative Team
Royal Women's Hospital · AUNational University of Singapore · SGRoyal Children's Hospital · AUSouth Australian Health and Medical Research Institute · AUThe University of Adelaide · AUThe University of Western Australia · AUUniversity of South Australia · AUWomen's and Children's Health Network · AUWomen's & Children's Health Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBronchopulmonary 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/

designThis 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 registrationAustralia and New Zealand Clinical Trial Registry: ACTRN12612000503820 . Registered 09 May 2012.

Indexed as

Dietary SupplementsBronchopulmonary DysplasiaClinical ProtocolsDocosahexaenoic AcidsDouble-Blind MethodEmulsionsEnteral NutritionFemaleFollow-Up StudiesHumansInfant, NewbornInfant, PrematureMaleTreatment OutcomeDocosahexaenoic AcidsEmulsionsBronchopulmonary dysplasiaDocosahexaenoic acidInfantn-3 long chain polyunsaturated fatty acidsPreterm

Identifiers

PMID27250120
PMCPMC4896378
OpenAlexW2411350885

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.