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

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04905732

Collaborator

Children's Hospital of Chongqing Medical University (Other)

200

Enrollment

Location

Arms

43.4

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia Nasal High-frequency Oscillatory Ventilation Nasal Continuous Positive Airway Pressure Neonate	Device: NHFOV Device: NCPAP	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAPAfter documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

After documenting parental consent, these ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP using a table of random numbers and sealed opaque envelopes when they were eligible for extubation. Blinding to doctor was not possible due to the nature of the intervention, is not necessary to participant.

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

re-intubation rate [seven days after extubation]
the newborn infants with ventilated BPD is reintubated after extubation
death [seven days after extubation]
the newborn infants with BPD die
the level of carbon dioxide [seven days after extubation]
the level of carbon dioxide is measure after extubation between groups

Secondary Outcome Measures

necrotizing entercolitis(NEC) [seven days after extubation]
the newborn infants with BPD is diagnosed with NEC
intraventricular hemorrhage(IVH) [seven days after extubation]
the newborn infants with BPD is diagnosed with NEC

Eligibility Criteria

Criteria

Ages Eligible for Study:

28 Days to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chen（陈）	Chongqing	Chongqing	China	400014

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Long,MD, director, Children's Hospital of Chongqing Medical University

ClinicalTrials.gov Identifier:

NCT04905732

Other Study ID Numbers:

NHFOV for sBPD

First Posted:

May 28, 2021

Last Update Posted:

May 28, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia

Study Results

No Results Posted as of May 28, 2021