Evidence map›Paper›PMID 29523175›Full record

Trial reportTrials2018

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study): statistical analysis plan.

Wes Onland, Maruschka P Merkus, Debbie H Nuytemans, Marijke C Jansen-van der Weide, Rebecca Holman, Anton H van Kaam, SToP-BPD study group

Open access · goldAbstract readClinical Trial, Phase IIILetterMulticenter Study
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
3.3field-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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
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

7 authors at 2 institutions in 1 country.

Wes OnlandDepartment of Neonatology, Emma Children's Hospital, Academic Medical Centre, Room H3-145, PO Box 22700, 1100, DD, Amsterdam, The Netherlands. w.onland@amc.uva.nl.ORCID http://orcid.org/0000-0002-9623-0606
Maruschka P MerkusClinical Research Unit, Academic Medical Centre, Amsterdam, The Netherlands.
Debbie H NuytemansDepartment of Neonatology, Emma Children's Hospital, Academic Medical Centre, Room H3-145, PO Box 22700, 1100, DD, Amsterdam, The Netherlands.
Marijke C Jansen-van der WeidePaediatric Clinical Research Office, Emma Children's Hospital, Academic Medical Centre, Amsterdam, The Netherlands.
Rebecca HolmanClinical Research Unit, Academic Medical Centre, Amsterdam, The Netherlands.
Anton H van KaamDepartment of Neonatology, Emma Children's Hospital, Academic Medical Centre, Room H3-145, PO Box 22700, 1100, DD, Amsterdam, The Netherlands.
SToP-BPD study group
Amsterdam UMC Location University of Amsterdam · NLEmma Kinderziekenhuis · NL

Funding

ZonMw 11-32010-02
6 · The paper itself

Abstract

backgroundBronchopulmonary dysplasia (BPD) is the most common complication of preterm birth with short-term and long-term adverse consequences. Although the glucocorticoid dexamethasone has been proven to be beneficial for the prevention of BPD, there are concerns about an increased risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. The aim of the Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (SToP-BPD) trial is to assess the efficacy and safety of postnatal hydrocortisone administration for the reduction of death or BPD in ventilator-dependent preterm infants. METHODS/

designThe SToP-BPD study is a multicentre, double-blind, placebo-controlled hydrocortisone trial in preterm infants at risk for BPD. After parental informed consent is obtained, ventilator-dependent infants are randomly allocated to hydrocortisone or placebo treatment during a 22-day period. The primary outcome measure is the composite outcome of death or BPD at 36 weeks postmenstrual age. Secondary outcomes are short-term effects on pulmonary condition and long-term neurodevelopmental sequelae assessed at 2 years corrected age. Complications of treatment, other serious adverse events and suspected unexpected serious adverse reactions are reported as safety outcomes. This pre-specified statistical analysis plan was written and submitted without knowledge of the unblinded data.

trial registrationNetherlands Trial Register, NTR2768 . Registered on 17 February 2011. EudraCT, 2010-023777-19. Registered on 2 November 2010.

Indexed as

Bronchopulmonary DysplasiaDouble-Blind MethodHumansHydrocortisoneInfant, NewbornInfant, PrematureOutcome Assessment, Health CareSample SizeHydrocortisoneBronchopulmonary dysplasiaHydrocortisoneMortalityPretermStatistical analysis plan

Identifiers

PMID29523175
PMCPMC5845134
OpenAlexW2791510998

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.