Bronchopulmonary DysplasiaNCT04905732
Nasal High-frequency Oscillatory Ventilation (NHFOV) for Ventilated Newborn Infants With BPD
A study testing NHFOV and NCPAP in people with Bronchopulmonary Dysplasia and Nasal High-frequency Oscillatory Ventilation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 28 days to 6 months
- Conditions the study is for
- Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure
- What is being tested?
- NHFOV and NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chen（陈）
Chongqing, Chongqing Municipality, 400014
Chen（陈） Long, MD,PhD, +8613883559467, neuroclong@126.com
About this study
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
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.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure, Neonate
- Being tested
- NHFOV, NCPAP
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NHFOVDevice
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
NCPAPDevice
After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
| Study group | Role | What they receive |
|---|---|---|
| NHFOV | Experimental | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV Receives: Device: NHFOV |
| NCPAP | Active comparator | After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP Receives: Device: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
re-intubation rate
the newborn infants with ventilated BPD is reintubated after extubation
Measured: seven days after extubation
death
the newborn infants with BPD die
Measured: seven days after extubation
the level of carbon dioxide
the level of carbon dioxide is measure after extubation between groups
Measured: seven days after extubation
Secondary outcomes (2)
necrotizing entercolitis(NEC)
the newborn infants with BPD is diagnosed with NEC
Measured: seven days after extubation
intraventricular hemorrhage(IVH)
the newborn infants with BPD is diagnosed with NEC
Measured: seven days after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start20 May 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905732
- Sponsor's protocol ID
- NHFOV for sBPD
- Status last verified
- Oct 2022
- First submitted
- 26 Feb 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04905732
- Acronym / sponsor ID
- NHFOV for sBPD
- Conditions
- Bronchopulmonary Dysplasia, Nasal High-frequency Oscillatory Ventilation, Nasal Continuous Positive Airway Pressure, Neonate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 20 May 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After documenting parental consent, the ventilated infants with BPD were randomly assigned to either NHFOV or NCPAP
| Arm | Type | Receives |
|---|---|---|
| NHFOV | Experimental | Device: NHFOVAfter documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV |
| NCPAP | Active comparator | Device: NCPAPAfter documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP |
Who may qualify
- Ages
- 28 days to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- there were no intraventricular hemorrhage(IVH) grades 3 or 4
- major congenital anomalies
- parents' decision not to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NHFOVAfter documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV | Device | NHFOV |
| NCPAPAfter documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP | Device | NCPAP |
Primary outcome
re-intubation rate
Time frame: seven days after extubation
the newborn infants with ventilated BPD is reintubated after extubation
death
Time frame: seven days after extubation
the newborn infants with BPD die
the level of carbon dioxide
Time frame: seven days after extubation
the level of carbon dioxide is measure after extubation between groups
2 secondary outcomes
necrotizing entercolitis(NEC)
Time frame: seven days after extubation
intraventricular hemorrhage(IVH)
Time frame: seven days after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NHFOV and NCPAP in people with Bronchopulmonary Dysplasia and Nasal High-frequency Oscillatory Ventilation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen（陈） Long, MD, PhD (+8613883559467, neuroclong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
re-intubation rate (time frame: seven days after extubation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.