Evidence map›Paper›PMID 34039414›Full record

Trial reportTrials2021

Baby-OSCAR: Outcome after Selective early treatment for Closure of patent ductus ARteriosus in preterm babies-a statistical analysis plan for short-term outcomes.

Jennifer L Bell, Samir Gupta, Edmund Juszczak, Pollyanna Hardy, Louise Linsell

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

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 28% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Review
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 1 country.

Jennifer L BellUniversity of Oxford, Oxford, UK. jennifer.bell@npeu.ox.ac.uk.ORCID http://orcid.org/0000-0001-9571-0715
Samir GuptaDurham University, Durham, UK.
Edmund JuszczakUniversity of Oxford, Oxford, UK.
Pollyanna HardyUniversity of Birmingham, Birmingham, UK.
Louise LinsellUniversity of Oxford, Oxford, UK.
University of Oxford · GBDurham University · GBUniversity of Birmingham · GBUniversity of Nottingham · GB

Funding

Health Technology Assessment Programme 11/92/15
6 · The paper itself

Abstract

backgroundThe Baby-OSCAR trial is a multi-centre, randomised, placebo-controlled parallel group trial of early treatment of large patent ductus arteriosus (PDA) with ibuprofen in extremely preterm infants. This paper describes the statistical analysis plan for the short-term health outcomes of the Baby-OSCAR trial. METHODS AND

designThis is a randomised controlled trial to determine if early-targeted treatment of a large PDA with parenteral ibuprofen in extremely preterm babies improves short and long-term health and economic outcomes. Infants born between 23

resultsBaseline demographic and clinical characteristics will be described by randomised group. The primary analysis will be on the modified intention to treat (ITT) population. Counts and percentages will be presented for binary and categorical variables, and mean and standard deviation or median and interquartile range will be presented for continuous variables. For binary outcomes, risk ratios and confidence intervals will be calculated using log binomial or Poisson regression with a robust variance estimator. Continuous outcomes will be analysed using linear regression models, or quantile regression models if skewed. Analyses will be adjusted for all minimisation factors where technically possible, and correlation between siblings from multiple births will be accounted for by nesting the clusters as a random effect. Both crude and adjusted effect estimates will be presented, with the primary inference based on the adjusted estimates. Ninety-five per cent confidence intervals will be used for all pre-specified outcome comparisons.

conclusionThis paper describes the statistical analysis plan for short-term health outcomes of the trial, including the analysis principles, definitions of important outcomes, methods for primary analysis, pre-specified subgroup analysis, and secondary analysis. The plan was finalised prior to completion of short-term follow-up.

trial registrationISRCTN registry ISRCTN84264977 . Registered on 15 September 2010.

Indexed as

Bronchopulmonary DysplasiaDuctus Arteriosus, PatentHumansIbuprofenInfantInfant, Extremely PrematureInfant, Low Birth WeightInfant, NewbornTreatment OutcomeIbuprofenBronchopulmonary dysplasiaEchocardiographyIbuprofenNewbornPatent ductus arteriosusPDAPretermRandomised controlled trialStatistical analysis plan

Identifiers

PMID34039414
PMCPMC8157743
OpenAlexW3165265124

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.