Evidence map›Paper›PMID 32883333›Full record

ArticleTrials2020

Hydrocortisone to treat early bronchopulmonary dysplasia in very preterm infants: study protocol for a randomized controlled trial.

Yuan He, Yong Zhang, Shuqiang Gao, Xiaoling Wang, Na He, Deshuang Zhang, Wenbin Dong, Christian Wieg, Xiaoping Lei

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.8field-weighted citation impact, top 24% 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, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  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

9 authors at 3 institutions in 2 countries.

Yuan HeDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.
Yong ZhangDepartment of Neonatology, Sichuan Provincial Hospital for Women and Children, Chengdu, Sichuan, China.
Shuqiang GaoDepartment of Neonatology, Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China.
Xiaoling WangDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.
Na HeDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.
Deshuang ZhangDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.
Wenbin DongDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China.
Christian WiegDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China. Christian.Wieg@klinikum-ab-alz.de.
Xiaoping LeiDepartment of Neonatology, Affiliated Hospital of Southwest Medical University, 25 Taiping Road, Luzhou, 646000, Sichuan, China. leixiaopingde@126.com.ORCID http://orcid.org/0000-0003-3818-7117
Affiliated Hospital of Southwest Medical University · CNChengdu Women's and Children's Central Hospital · CNSouthwest Medical University · CN

Funding

Southwest Medical University 2015SX-0056
6 · The paper itself

Abstract

backgroundBronchopulmonary dysplasia (BPD) is still a common complication in very premature infants. At present, there is no effective treatment for BPD. Glucocorticoids are drugs commonly used to prevent or treat BPD before and after birth. In very premature infants with high risk factors for BPD, early use of dexamethasone can reduce the rate of death and/or BPD but may cause long-term adverse neurodevelopmental outcomes. Hydrocortisone (HC), as an alternative drug to dexamethasone, has been increasingly used to prevent BPD. However, no study has reported the efficacy and safety of HC to treat early BPD diagnosed at postnatal day (PND) 28.

methodsThis study protocol is for a multicenter double-blind randomized controlled trial of low-dose HC in the treatment of early BPD. Early BPD infants will be randomly assigned to the HC treatment group or control group. Infants in the HC group will receive 0.5 mg/kg HC twice a day for 7 days and then 0.5 mg/kg HC once a day for 3 days. The control group will be given the same volume of placebo and no intervention on the basis of routine treatment. The primary outcome is survival without moderate or severe BPD at 36 weeks postmenstrual age. Secondary outcomes are the short- and long-term effects on growth, metabolism, neurodevelopment, and other possible complications. DISCUSSION: This trial will determine the efficacy and safety of low-dose HC administration compared to placebo for the reduction of moderate or severe BPD at 36 weeks postmenstrual age in very preterm infants with early BPD.

trial registrationChina Clinical Trial Registration Center ChiCTR1900021854 . Registered on 13 March 2019.

Indexed as

Bronchopulmonary DysplasiaHydrocortisoneChinaHumansInfantInfant, NewbornInfant, PrematureInfant, Very Low Birth WeightMulticenter Studies as TopicRandomized Controlled Trials as TopicHydrocortisoneBronchopulmonary dysplasiaHydrocortisonePreterm infants

Identifiers

PMID32883333
PMCPMC7469331
OpenAlexW3081704478

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.