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

Trials · 11 authors, 2 centres

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TL;DR

This is a protocol for a multi-center randomized controlled trial comparing three noninvasive ventilation modes (HFNC, CPAP, and NIPPV) as primary respiratory support in newborns ≥32 weeks gestational age.

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The study will enroll neonates aged ≥32 weeks' gestation requiring primary noninvasive ventilation within the first 24 hours of life and randomly assign them to receive HFNC, CPAP, or NIPPV. The analysis will be intention-to-treat. Key limitations noted in the protocol include the inability to blind healthcare professionals to the ventilation mode and the grouping of traditional NIPPV with BiPAP.

STUDY TYPE

other

SPECIALTY

pediatrics

SUMMARISED BY

AI pipeline

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ORIGINAL PAPER

PMC10557210

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

Trials

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ABSTRACT

Abstract Background Health 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. Methods This 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 registration Chinese Clinical Trial Registry: ChiCTR2300069192. Registered on March 9, 2023, https://www.chictr.org.cn/showproj.html?proj=171491 . Keywords: Neonates, Noninvasive ventilation, High-flow nasal cannula, Nasal intermittent positive pressure ventilation, Continuous positive airway pressure, Randomised controlled trial

CITATION EXPORT

Rong Zhou, Tao Xiong, Jun Tang et al.. 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. Trials. (2023). https://doi.org/10.1186/s13063-023-07665-7

AUTHORS

11 · 2 CENTRES

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

1Department of Pediatrics, West China Second University Hospital, Sichuan University, No. 20, Section Three, South Renmin Road, Chengdu, China
2Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University) Ministry of Education, Chengdu, China