Evidence map›Paper›PMID 37803402›Full record

ArticleTrials2023

High-flow nasal cannula (HFNC) vs continuous positive airway pressure (CPAP) vs nasal intermittent positive pressure ventilation as primary respiratory support in infants of ≥ 32 weeks gestational age (GA): study protocol for a three-arm multi-center randomized controlled trial.

Rong Zhou, Tao Xiong, Jun Tang, Yi Huang, Wenli Liu, Jun Zhu, Chao Chen, Lingyue Gong, Ke Tian, Aoyu Wang and 1 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
0.5field-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

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. 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

11 authors at 1 institution in 1 country.

Rong ZhouDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Tao XiongDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China. tao_xiong@126.com.ORCID http://orcid.org/0000-0002-0408-1288
Jun TangDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Yi HuangDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Wenli LiuDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Jun ZhuDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Chao ChenDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Lingyue GongDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Ke TianDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Aoyu WangDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Dezhi MuDepartment of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China.
Sichuan University · CN

Funding

National Key R&D Program 2021YFC2701700
6 · The paper itself

Abstract

backgroundHealth problems in neonates with gestational age (GA) ≥ 32 weeks remain a major medical concern. Respiratory distress (RD) is one of the common reasons for admission of neonates with GA ≥ 32 weeks. Noninvasive ventilation (NIV) represents a crucial approach to treat RD, and currently, the most used NIV modes in neonatal intensive care unit include high-flow nasal cannula (HFNC), continuous positive airway pressure (CPAP), and nasal intermittent positive pressure ventilation. Although extensive evidence supports the use of NIPPV in neonates with a GA < 32 weeks, limited data exist regarding its effectiveness in neonates with GA ≥ 32 weeks. Therefore, the aim of this study is to compare the clinical efficacy of HFNC, CPAP, and NIPPV as primary NIV in neonates with GA ≥ 32 weeks who experience RD.

methodsThis trial is designed as an assessor-blinded, three-arm, multi-center, parallel, randomized controlled trial, conducted in neonates ≥ 32 weeks' GA requiring primary NIV in the first 24 h of life. The neonates will be randomly assigned to one of three groups: HFNC, CPAP or NIPPV group. The effectiveness, safety and comfort of NIV will be evaluated. The primary outcome is the occurrence of treatment failure within 72 h after enrollment. Secondary outcomes include death before discharge, surfactant treatment within 72 h after randomization, duration of both noninvasive and invasive mechanical ventilation, duration of oxygen therapy, bronchopulmonary dysplasia, time to achieve full enteral nutrition, necrotizing enterocolitis, duration of admission, cost of admission, air leak syndrome, nasal trauma, and comfort score. DISCUSSION: Currently, there is a paucity of data regarding the utilization of NIPPV in neonates with GA ≥ 32 weeks. This study will provide clinical evidence for the development of respiratory treatment strategies in neonates at GA ≥ 32 weeks with RD, with the aim of minimizing the incidence of tracheal intubation and reducing the complications associated with NIV.

trial registrationChinese Clinical Trial Registry: ChiCTR2300069192. Registered on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=171491 .

Indexed as

Noninvasive VentilationRespiratory Distress Syndrome, NewbornCannulaContinuous Positive Airway PressureDyspneaGestational AgeHumansInfantInfant, NewbornInfant, PrematureIntermittent Positive-Pressure VentilationMulticenter Studies as TopicRandomized Controlled Trials as TopicContinuous positive airway pressureHigh-flow nasal cannulaNasal intermittent positive pressure ventilationNeonatesNoninvasive ventilationRandomised controlled trial

Identifiers

PMID37803402
PMCPMC10557210
OpenAlexW4387401121

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.