Respiratory Distress Syndrome (& [Hyaline Membrane Disease])NCT07377955
Combined Oscillation-Volume guarantEe Study
A study testing HFOV and HFOV+VG in people with Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) and Bronchopulmonary Dysplasia (BPD), run by Xingwang Zhu.
Trial summary
Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Bronchopulmonary Dysplasia (BPD)
- What is being tested?
- HFOV and HFOV+VG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age 24+0/7< 320/7 weeks
- Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV
Who cannot join
- Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
- Uncorrected shock
- Existence of grade 3-4 IVH before ventilated
- Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)
Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.
HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.
This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Bronchopulmonary Dysplasia (BPD)
- Being tested
- HFOV, HFOV+VG
- Medical subject headings
- Respiratory Distress Syndrome, Hyaline Membrane Disease, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFOVDevice
HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits
HFOV+VGDevice
HFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit
| Study group | Role | What they receive |
|---|---|---|
| HFOV | Active comparator | HFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers21-23 to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits Receives: Device: HFOV |
| HFOV+VG | Active comparator | HFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit. Receives: Device: HFOV+VG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
Measured: 36 weeks gestational age
Secondary outcomes (15)
In-hospital death at 36 weeks' PMA
Measured: 36 weeks gestational age
The incidence of BPD at 36 weeks' PMA
Measured: 36 weeks gestational age
The duration of invasive ventilation at the time of the first successful extubation
Measured: through study completion, an average of 1 year
Surfactant doses
Measured: through study completion, an average of 1 year
The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period
Measured: through study completion, an average of 1 year
Pulmonary hypertension (PH) requiring iNO treatment, including PPHN within 7 days after birth and cPH after 28 days of life
Measured: through study completion, an average of 1 year
hsPDA (Iowa score ≥6 )
Measured: through study completion, an average of 1 year
The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP)
Measured: through study completion, an average of 1 year
The incidence of Grade III to IV IVH according to Papile 1978 criteria
Measured: through study completion, an average of 1 year
The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria
Measured: through study completion, an average of 1 year
The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life)
Measured: through study completion, an average of 1 year
The incidence of Retinopathy of premature > grade II
Measured: through study completion, an average of 1 year
The duration of hospitalization
Measured: through study completion, an average of 1 year
Weight gain (g/kg/day)
Measured: through study completion, an average of 1 year
The incidence of discharge against medical advice (DAMA)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome (& [Hyaline Membrane Disease])Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xingwang Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Affiliated Hospital of Jining Medical University, Chongqing Qianjiang Central Hospital, First People's Hospital of Chenzhou, Fujian Maternity and Child Health Hospital, Fuling Hospital of Chongqing University, Guangdong Women and Children Hospital, Zhengzhou Children's Hospital, China, Hunan Children's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Hunan Provincial People's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, People's Hospital of MeiShan, QuanZhou Women and Children's Hospital, Qujing Maternal and Child Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Shanxi Women and Children Hospital, Shenzhen Longhua Maternity and Child Health Care Hospital, Shijiazhuang Obstetrics and Gynecology Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Women and Children's Hospital of Ningbo University, Zhangzhou Affiliated Hospital of Fujian Medical School
- Responsible party
- Sponsor-investigator, Xingwang Zhu, Jiulongpo No.1 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377955
- Sponsor's protocol ID
- Combined Oscillation-Volume gu
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers who wish to use the data may apply by emailing the principal investigator with a comprehensive study protocol. After the primary results of this trial have been published, the full, de-identified dataset will be made available to all participating sites of COVES for secondary analyses.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Volume Guarantee High-Frequency Oscillatory Ventilation (HFOV-VG) Versus Conventional High-Frequency Oscillatory Ventilation (HFOV) on Grade 2 to 3 Bronchopulmonary Dysplasia (BPD) or Death in Preterm Infants <32 Weeks With Respiratory Distress Syndrome (RDS)
- ClinicalTrials.gov ID
- NCT07377955
- Acronym / sponsor ID
- Combined Oscillation-Volume gu
- Conditions
- Respiratory Distress Syndrome (& [Hyaline Membrane Disease]), Bronchopulmonary Dysplasia (BPD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Xingwang ZhuUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University, The Affiliated Hospital of Inner Mongolia Medical University, Affiliated Hospital of Jining Medical University, Chongqing Qianjiang Central Hospital, First People's Hospital of Chenzhou, Fujian Maternity and Child Health Hospital, Fuling Hospital of Chongqing University, Guangdong Women and Children Hospital, Zhengzhou Children's Hospital, China, Hunan Children's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Hunan Provincial People's Hospital, Inner Mongolia Maternal and Child Health Care Hospital, Jiangxi Maternal and Child Health Hospital, Kunming Children's Hospital, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Moscow Regional Research Institute of Obstetrics and Gynecology named after Academician V. I. Krasnopolsky, Northwest Women's and Children's Hospital, Xi'an, Shaanxi, People's Hospital of MeiShan, QuanZhou Women and Children's Hospital, Qujing Maternal and Child Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University, Shanxi Women and Children Hospital, Shenzhen Longhua Maternity and Child Health Care Hospital, Shijiazhuang Obstetrics and Gynecology Hospital, The Third Affiliated Hospital of Guangzhou Medical University, Women and Children's Hospital of Ningbo University, Zhangzhou Affiliated Hospital of Fujian Medical School
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 30 Jan 2026 (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.
Respiratory Distress Syndrome (RDS) remains the most common respiratory complication in the early postnatal period among preterm infants born before 32 weeks' gestational age. For this population, implementing lung-protective ventilation strategies is essential to shorten the duration of intubation, reduce the incidence and severity of bronchopulmonary dysplasia (BPD), lower mortality, and improve overall outcomes.
HFOV-VG was first reported in 2015 to be safely applied in neonates. The fundamental principle lies in its ability to stabilize the tidal volume of high-frequency ventilation (VThf), thereby reducing sheer stress from amplitude fluctuations, while simultaneously permitting lower VThf settings to minimize volutrauma.
This study aims to evaluate whether HFOV+VG is superior to HFOV in reducing the composite outcome of grade 2-3 BPD or death at 36 weeks' post-menstrual age (PMA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFOV | Active comparator | Device: HFOVHFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers21-23 to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits |
| HFOV+VG | Active comparator | Device: HFOV+VGHFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age 24+0/7< 320/7 weeks
- Diagnosis of RDS within 72 hours after birth, requiring endotracheal ventilation for both elective and rescue HFOV
Key exclusion criteria (4 listed)
- Severe birth defects: severe congenital heart disease, diaphragmatic hernia, gastrointestinal malformations, congenital brain developmental abnormalities, congenital pulmonary cysts
- Uncorrected shock
- Existence of grade 3-4 IVH before ventilated
- Other conditions deemed unsuitable for enrollment by neonatologists, including endotracheal intubation performed specifically for the purpose of the INSURE or INRECSURE technique.
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 |
|---|---|---|
| HFOVHFOV: 1) Mean airway pressure (MAP) and FiO2: titrated via oxygenation-guided lung recruitment maneuvers to maintain preductal SpO2 target of 89%-94%. 2) Frequency: 12-15 Hz for birth weight (BW)<1500g, and 10-12 Hz for BW≥ 1500g. 3) I:E ratio: 1:1 or 1:2 according to recommendations of manufacturers and local habits | Device | HFOV |
| HFOV+VGHFOV-VG Group: ①VThf: <1000g 1.5-1.8ml/kg, 1000-1500g 1.8-2.2ml/kg, >1500g, 2.2-2.5ml/kg; ②Amplitude automatically adjusted by volume guarantee algorithm and the upper limit was set at 15% above the measured value after achieving the target VThf, with the constraint that it must not exceed 20 cm H2O for BW<1000g, 25cm H2O for BW 1000-1500g or 25-30 cmH2O for BW>1500g; ③If the target VThf is not achieved after the amplitude has reached its upper limit, airway issues (e.g., suctioning) or lung recruitment should be addressed first, rather than overriding the amplitude limit | Device | HFOV+VG |
Primary outcome
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA
Time frame: 36 weeks gestational age
15 secondary outcomes
In-hospital death at 36 weeks' PMA
Time frame: 36 weeks gestational age
The incidence of BPD at 36 weeks' PMA
Time frame: 36 weeks gestational age
The duration of invasive ventilation at the time of the first successful extubation
Time frame: through study completion, an average of 1 year
Surfactant doses
Time frame: through study completion, an average of 1 year
The incidence of normocapnia, hypercapnia, and hypocapnia during the intervention period
Time frame: through study completion, an average of 1 year
Pulmonary hypertension (PH) requiring iNO treatment, including PPHN within 7 days after birth and cPH after 28 days of life
Time frame: through study completion, an average of 1 year
hsPDA (Iowa score ≥6 )
Time frame: through study completion, an average of 1 year
The incidence of massive pulmonary hemorrhage, pneumothorax, pneumomediastinum, pneumopericardium, and ventilator-associated pneumonia(VAP)
Time frame: through study completion, an average of 1 year
The incidence of Grade III to IV IVH according to Papile 1978 criteria
Time frame: through study completion, an average of 1 year
The incidence of Necrotizing enterocolitis (NEC) > grade II according to Modified Bell's Staging Criteria
Time frame: through study completion, an average of 1 year
The incidence of Culture-proven late-onset sepsis (onset after 72 hours of life)
Time frame: through study completion, an average of 1 year
The incidence of Retinopathy of premature > grade II
Time frame: through study completion, an average of 1 year
The duration of hospitalization
Time frame: through study completion, an average of 1 year
Weight gain (g/kg/day)
Time frame: through study completion, an average of 1 year
The incidence of discharge against medical advice (DAMA)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes. Researchers who wish to use the data may apply by emailing the principal investigator with a comprehensive study protocol. After the primary results of this trial have been published, the full, de-identified dataset will be made available to all participating sites of COVES for secondary analyses.
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.
Questions about this trial
What is this clinical trial studying?
A study testing HFOV and HFOV+VG in people with Respiratory Distress Syndrome (& [Hyaline Membrane Disease]) and Bronchopulmonary Dysplasia (BPD), run by Xingwang Zhu.
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 2 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: opening soon, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Shi, PhD (+86 23 68757731, shiyuan@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of grade 2-3 BPD or in-hospital death at 36 weeks' PMA (time frame: 36 weeks gestational age). 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 30 Jan 2026.