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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchopulmonary Dysplasia; Nasal Continuous Positive Airway Pressure; Neonate; Nasal High-frequency Oscillatory Ventilation
• Intervention / Treatment: Device: NHFOV; Device: NCPAP

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chen（陈） Long, MD, PhD; Phone Number: +8613883559467; Email: neuroclong@126.com

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Chen（陈）
      • Contact: Chen（陈） Long, MD,PhD; Phone Number: +8613883559467; Email: neuroclong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NHFOV; After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV	Device: NHFOV; After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
Active Comparator: NCPAP; After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP	Device: NCPAP; After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
re-intubation rate	the newborn infants with ventilated BPD is reintubated after extubation	seven days after extubation
death	the newborn infants with BPD die	seven days after extubation
the level of carbon dioxide	the level of carbon dioxide is measure after extubation between groups	seven days after extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
necrotizing entercolitis(NEC)	the newborn infants with BPD is diagnosed with NEC	seven days after extubation
intraventricular hemorrhage(IVH)	the newborn infants with BPD is diagnosed with NEC	seven days after extubation

Collaborators and Investigators

• Sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
• Collaborators: Children's Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: February 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: NHFOV for sBPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No