Non-invasive high-frequency oscillatory ventilation versus nasal continuous positive airway pressure in extremely preterm infants with respiratory distress syndrome: study protocol for a multicentre randomised controlled, superiority trial

Abstract

Introduction: Tracheal intubation and invasive mechanical ventilation (IMV) significantly decreased mortality of respiratory distress syndrome (RDS) in extremely preterm infants (28 weeks' gestational age) whereas bronchopulmonary dysplasia increased. Thus, consensus guidelines recommend the use of non-invasive ventilation (NIV), as the preferred first-line approach for these infants. This trial aims to compare the effect of nasal continuous positive airway pressure (NCPAP) and non-invasive high-frequency oscillatory ventilation (NHFOV) as the primary respiratory support in extremely preterm infants with RDS.

Methods and analysis: We designed a multicentre, randomised, controlled, superiority trial investigating the effect of NCPAP and NHFOV as the primary respiratory support in extremely preterm infants with RDS in neonatal intensive units in China. At least 340 extremely preterm infants with RDS will be randomised to NHFOV or NCPAP as a primary mode of NIV. The primary outcomes will be the respiratory support failure determined by the need for IMV within 72 hours from birth.

Ethics and dissemination: Our protocol has been approved by the Ethics Committee of Children's Hospital of Chongqing Medical University. We will present our findings at national conferences and peer-reviewed paediatrics journals.

Trial registration number: NCT05141435.

Keywords: NEONATOLOGY; Paediatric intensive & critical care; RESPIRATORY MEDICINE (see Thoracic Medicine).

Figure 1

Flow diagram of the trial protocol. BPD, bronchopulmonary dysplasia; IVH, intracranial haemorrhage; NEC, necrotising enterocolitis; RDS, respiratory distress syndrome; ROP, retinopathy of prematurity.

Figure 2

Timeline of the study and clinical data collection according to SPIRIT guidelines. BPD, bronchopulmonary dysplasia; IMV, invasive mechanical ventilation; IVH, intracranial haemorrhage; NCPAP, nasal continuous positive airway pressure; NEC, necrotising enterocolitis; NHFOV, non-invasive high-frequency oscillatory ventilation; NICU, neonatal intensive care unit; PMA, postmenstrual age; ROP, retinopathy of prematurity; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials. **Follow-up schedule.