Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Nasal High-frequency Oscillatory Ventilation (NHFOV) vs Nasal Continuous Positive Airway Pressure(NCPAP) for Ventilated Newborn Infants With BPD: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04905732
• Other study ID #: NHFOV for sBPD
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Contact: Chen(?) Long, MD, PhD
• Phone: +8613883559467
• Email: neuroclong[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Invasive ventilation(IV) remains one key cornerstone to reduce neonatal mortality for preterm infants with respiratory distress syndrome(RDS) and/or acute respiratory distress syndrome(ARDS). However, it is also related to increased risks of ventilator-associated lung injury and escalation of pulmonary inflammation, and which finally result in bronchopulmonary dysplasia (BPD). Early weaning from IV in newborn infants with BPD is therefore a key procedure to reduce these risks above.

Description:

Supplying with the combined advantages of NCPAP and high-frequency oscillatory ventilation (HFOV) with high carbon dioxide(CO2) removal, no need for synchronisation, non-invasion, less volume/barotraumas, and increased functional residual capacity, nasal HFOV(NHFOV) was considered as a strengthened version of NCPAP. Furthermore, the superimposed oscillations of NHFOV could avoid gas-trapping, and allowed to obviously up-regulate mean airway pressure (MAP) more than NCPAP. Thus, NHFOV might be more beneficial as post-extubation respiratory support strategy to avoid re-intubation and subsequent complications and/or sequelae as compared with NCPAP in preterm infants. Nowadays, NHFOV was increasingly used in neonatal intensive care unit (NICU) around the world due to its convenient operation. A retrospective review has reported the beneficial effects of NHFOV in preterm infants as a remedial measure after failing to other noninvasive modes, including reducing the number of apneas, bradycardias or oxygen desaturations. However, there were rare randomized controlled studies comparing NHFOV with NCPAP in preterm infants with BPD.

We have found that NHFOV is superior to NCPAP in avoiding re-intubation in very preterm infants with the first extubation. The purpose of the present study was to compare NHFOV with NCPAP as post-extubation respiratory support strategies on the need for endotracheal ventilation, as well as pressure of CO2(PCO2) level in preterm infants with BPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Days to 6 Months

Eligibility

Inclusion Criteria:

Eligibility requirements for neonates:

• The gestational age is less than 32 weeks

• The preterm neonates are diagnosed with BPD and need invasive ventilation

• Extubation and subsequent noninvasive ventilation is ready to be carried out

Exclusion Criteria:

one of the following conditions is needed:

• there were no intraventricular hemorrhage(IVH) grades 3 or 4

• major congenital anomalies

• parents' decision not to participate

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Nasal Continuous Positive Airway Pressure
• Neonate

Intervention

Device:
• NHFOV
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
• NCPAP
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP

Locations

Country	Name	City	State
China	Chen(?)	Chongqing	Chongqing

Sponsors (2)

Lead Sponsor	Collaborator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	re-intubation rate	the newborn infants with ventilated BPD is reintubated after extubation	seven days after extubation
Primary	death	the newborn infants with BPD die	seven days after extubation
Primary	the level of carbon dioxide	the level of carbon dioxide is measure after extubation between groups	seven days after extubation
Secondary	necrotizing entercolitis(NEC)	the newborn infants with BPD is diagnosed with NEC	seven days after extubation
Secondary	intraventricular hemorrhage(IVH)	the newborn infants with BPD is diagnosed with NEC	seven days after extubation