Clinical trial NCT04905732: Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchopulmonary Dysplasia
Nasal High-frequency Oscillatory Ventilation
Nasal Continuous Positive Airway Pressure
Neonate
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-05-28
Enrollment: 200
Sex: ALL
Minimum age (years): 28
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: re-intubation rate
timeFrame: seven days after extubation
measure: death
timeFrame: seven days after extubation
measure: the level of carbon dioxide
timeFrame: seven days after extubation
Secondary outcomes:
measure: necrotizing entercolitis(NEC)
timeFrame: seven days after extubation
measure: intraventricular hemorrhage(IVH)
timeFrame: seven days after extubation
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chen（陈）
state: Chongqing
Study officials:
References: