NCT03140891

Nasal High Frequency Oscillation Ventilation(NHFOV) for Respiratory Distress Syndrome

Nasal High Frequency Oscillation Ventilation(NHFOV) vs. Nasal Continuous Positive Airway Pressure(NCPAP) as Post-extubation Respiratory Support in Preterm Infants With Respiratory Distress Syndrome:a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
• Sex: All
• Age: 30 Minutes – 1 Month
• Healthy volunteers: Not accepted

Summary

In very preterm infants with severe respiratory distress syndrome(RDS), invasive ventilation(IV) , besides nasal continuous positive airway pressure (NCPAP) and early/selective pulmonary surfactant administration, is one key cornerstone to reduce neonatal mortality. However, IV is related to increased risks of bronchopulmonary dysplasia (BPD) and abnormal developmental outcomes in the survival.Weaning from IV is therefore a key procedure to reducing these risks above, and if extubation does not success, repeated intubation and/or prolonged duration of IV will result in increased medical burden and intubation-associated complications and death. How to minimize the need for endotracheal ventilation and subsequent complications constitutes a challenge for neonatologists.

Detailed description

Early weaning from invasive ventilation and avoiding re-intubation remains a focus. Nowadays, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. NCPAP is a widely used way of noninvasive ventilation strategies in preterm infants. However, there is only 60% success rate in avoiding intubation. Supplying with the combined advantages of HFOV and NCPAP with high CO2 removal, no need for synchronisation, less volume/barotraumas, non-invasion and increased functional residual capacity, nasal high frequency oscillation ventilation (NHFOV) is considered as a strengthened version of NCPAP. Thus, NHFOV may be more effective as post-extubation respiratory support to avoid re-intubation and subsequent complications/sequelae comparing with NCPAP in preterm infants. To date, NHFOV was used increasingly in neonatal intensive care unit (NICU) around the world due to its convenient operation and no consideration of synchronisation, and several small studies have reported the beneficial effects of NHFOV in preterm infants. However, there were rare randomized controlled studies compared NHFOV with NCPAP as post-extubation respiratory support strategies in preterm infants. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support on the need for endotracheal ventilation and subsequent complications in preterm infants.

Conditions

• Respiratory Distress Syndrome
• Preterm Infant

Interventions

Type	Name	Description
DEVICE	NHFOV	NHFOV is used as the noninvasive mode after extubation
DEVICE	NCPAP	NCPAP is used as the noninvasive mode after extubation

Timeline

• Start date: 2017-04-15
• Primary completion: 2018-06-30
• Completion: 2018-06-30
• First posted: 2017-05-04
• Last updated: 2019-02-15

Locations

1 site across 1 country: China