Acute Respiratory Distress SyndromeNCT03591796
Invasive Ventilation for Neonates With Acute Respiratory Distress Syndrome(ARDS)
A study testing HFOV and CMV in people with Acute Respiratory Distress Syndrome and Conventional Mechanical Ventilation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated. Read more about this study
- Who is it for?
- Ages 1 minute to 12 hours
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
- What is being tested?
- HFOV and CMV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 386 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2024to 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 1 minute to 12 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) between 25+0 and 34+0 weeks;
- Assisted with CMV within 12 h after birth;
- Diagnosis with ARDS;
- Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg and > 35% of hematocrit
Who cannot join
- parents' decision not to participate;
- Major congenital anomalies or chromosomal abnormalities;
- Upper respiratory tract abnormalities;
- need for surgery before randomization;
- Grade Ⅲ-IV-intraventricular hemorrhage (IVH).
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.
Read the detailed description
Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.
- Conditions
- Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
- Being tested
- HFOV, CMV
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFOVDevice
Ventilated infants were randomized to HFOV
CMVDevice
Ventilated infants were randomized to CMV.
| Study group | Role | What they receive |
|---|---|---|
| HFOV | Experimental | Ventilated infants were randomized to HFOV. Receives: Device: HFOV |
| CMV | Active comparator | Ventilated infants were randomized to CMV. Receives: Device: CMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of bronchopulmonary dysplasia (BPD)
the included neonate was diagnosed with BPD
Measured: 28 days after birth or 36 weeks'gestational age
Death
the included preterm infants were dead
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
Secondary outcomes (5)
the incidence of neonatal necrotizing enterocolitis(NEC)
the included neonate was diagnosed with NEC
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
the incidence of retinopathy of prematurity(ROP)
the included neonate was diagnosed with ROP
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
Intraventricular hemorrhage
Intraventricular hemorrhage was diagnosed
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
composite mortality/BPD
composite mortality/BPD was diagnosed
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
the incidence of airleak
the included neonate was diagnosed with airleak
Measured: 28 days after birth or 36 weeks'gestational age or before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start31 Dec 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 386 participants (actual)
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, Jiulongpo No.1 People's Hospital, Chongqing Maternal and Child Health Hospital, The First Affiliated Hospital of Anhui Medical University, Children's Hospital of The Capital Institute of Pediatrics, Peking University Third Hospital, First Hospital of Tsinghua University, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Chongqing Medical University, Quanzhou Children's Hospital, Xiamen Maternity & Child Care Hospital, Zhujiang Hospital, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Women and Children's Health Hospital of Yulin, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Guangzhou Medical University, Guiyang Maternal and Child Health Care Hospital, The First People's Hospital of Zunyi, Lanzhou University Second Hospital, Gansu Provincial Maternal and Child Health Care Hospital, LanZhou University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Zhengzhou Children's Hospital, China, Third Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, Bethune International Peace Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Children's Hospital of Fudan University, Maternal and Children's Healthcare Hospital of Taian, The Second Hospital of Shandong University, Shanxi Provincial Maternity and Children's Hospital, Chengdu Women and Children's Center Hospital, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen People's Hospital, The Second Medical College of Jinan University, Tianjin Central Hospital of Gynecology Obstetrics, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming Children's Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Women and Children's Health Hospital of Qujing, The People's Hospital of Dehong Autonomous Prefecture, The First People's Hospital of Yinchuan, The Children's Hospital of Zhejiang University School of Medicine, Women's Hospital School Of Medicine Zhejiang University, Beijing 302 Hospital, Hunan Children's Hospital, Women and Children Hospital of Qinghai Province, Jiangxi Province Children's Hospital, Inner Mongolia People's Hospital, Mianyang Central Hospital, People's Liberation Army No.202 Hospital, Ningbo Women & Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Nanjing Medical University, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital, The First Affiliated Hospital of Zhengzhou University, Xianyang Children's Hospital
- Responsible party
- Principal investigator, Chen Long,MD, Children's Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591796
- Sponsor's protocol ID
- invasive ventilation for ARDS
- Status last verified
- Oct 2022
- First submitted
- 9 Jul 2018
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
Publications
Li J, Liu K, Yang Q, Tan Q, Feng Z, Shi Y, Chen L, Li LJ. High-Frequency Oscillation vs Mechanical Ventilation for Neonatal Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260268. doi: 10.1001/jamanetworkopen.2026.0268.
PubMed 41801204
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective High Frequency Oscillation Ventilation(HFOV) vs Conventional Mechanical Ventilation(CMV) for Neonates With Acute Respiratory Distress Syndrome(ARDS):an Multicenters Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03591796
- Acronym / sponsor ID
- invasive ventilation for ARDS
- Conditions
- Acute Respiratory Distress Syndrome, Conventional Mechanical Ventilation, High Frequency Oscillation Ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- 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, Jiulongpo No.1 People's Hospital, Chongqing Maternal and Child Health Hospital, The First Affiliated Hospital of Anhui Medical University, Children's Hospital of The Capital Institute of Pediatrics, Peking University Third Hospital, First Hospital of Tsinghua University, Women and Children's Hospital, Branch of Chongqing Sanxia Central Hospital, First Affiliated Hospital of Chongqing Medical University, Quanzhou Children's Hospital, Xiamen Maternity & Child Care Hospital, Zhujiang Hospital, Guangdong Academy of Medical Science and General Hospital, Guangdong Women and Children Hospital, Women and Children's Health Hospital of Yulin, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Second Affiliated Hospital of Guangzhou Medical University, Guiyang Maternal and Child Health Care Hospital, The First People's Hospital of Zunyi, Lanzhou University Second Hospital, Gansu Provincial Maternal and Child Health Care Hospital, LanZhou University, First Affiliated Hospital of Harbin Medical University, First Affiliated Hospital of Xinjiang Medical University, Zhengzhou Children's Hospital, China, Third Affiliated Hospital of Zhengzhou University, the Maternal and Child Health Hospital of Hainan Province, Bethune International Peace Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Children's Hospital of Nanjing Medical University, The First Hospital of Jilin University, Children's Hospital of Fudan University, Maternal and Children's Healthcare Hospital of Taian, The Second Hospital of Shandong University, Shanxi Provincial Maternity and Children's Hospital, Chengdu Women and Children's Center Hospital, The Affiliated Hospital Of Southwest Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen People's Hospital, The Second Medical College of Jinan University, Tianjin Central Hospital of Gynecology Obstetrics, People's Hospital of Xinjiang Uygur Autonomous Region, Kunming Children's Hospital, The First People's Hospital of Yunnan, First Affiliated Hospital of Kunming Medical University, Yan'an Affiliated Hospital of Kunming Medical University, Women and Children's Health Hospital of Qujing, The People's Hospital of Dehong Autonomous Prefecture, The First People's Hospital of Yinchuan, The Children's Hospital of Zhejiang University School of Medicine, Women's Hospital School Of Medicine Zhejiang University, Beijing 302 Hospital, Hunan Children's Hospital, Women and Children Hospital of Qinghai Province, Jiangxi Province Children's Hospital, Inner Mongolia People's Hospital, Mianyang Central Hospital, People's Liberation Army No.202 Hospital, Ningbo Women & Children's Hospital, Shanghai Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Nanjing Medical University, Qinhuangdao Maternal and Child Health Care Hospital, Xuzhou Children Hospital, The First Affiliated Hospital of Zhengzhou University, Xianyang Children's Hospital
- Study start
- 31 Dec 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Jul 2018 (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.
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017.The death rate is over 50%. HFOV and CMV are two main invasive ventilation strategies. However, which one is better needing to be further elucidated.
Detailed description
Severe acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. Usually, invasive ventilation with low parameters is enough for neonates with mild and moderate ARDS. And extracorporeal membrane oxygenation is used to neonates with severe ARDS. However, extracorporeal membrane oxygenation can also lead to high death rate and need more technique and conditions. Mechanical ventilation with higher parameters was a substitute for such situations, but the death rate, complications and injuries of higher parameters is unknown. The purpose of the present study was to compare HFOV with CMV as invasive respiratory support strategies on decrease the mortality and morbidities in neonate with ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- When the neonate had fulfilled the included criteria, selective HFOV or CMV were started immediately on the basis of the group assignment.
| Arm | Type | Receives |
|---|---|---|
| HFOV | Experimental | Device: HFOVVentilated infants were randomized to HFOV. |
| CMV | Active comparator | Device: CMVVentilated infants were randomized to CMV. |
Who may qualify
- Ages
- 1 minute to 12 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age (GA) between 25+0 and 34+0 weeks;
- Assisted with CMV within 12 h after birth;
- Diagnosis with ARDS;
- Stabilization for 2 hours before randomization: FiO2 0.40, mean airway pressure (MAP) 10-14 cmH2O, ≤ 40 bpm of respiratory rate, 90%-94% of SpO2, pH > 7.20, PaCO2 60 mmHg and > 35% of hematocrit
Key exclusion criteria (5 listed)
- parents' decision not to participate;
- Major congenital anomalies or chromosomal abnormalities;
- Upper respiratory tract abnormalities;
- need for surgery before randomization;
- Grade Ⅲ-IV-intraventricular hemorrhage (IVH).
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 |
|---|---|---|
| HFOVVentilated infants were randomized to HFOV | Device | HFOV |
| CMVVentilated infants were randomized to CMV. | Device | CMV |
Primary outcome
the incidence of bronchopulmonary dysplasia (BPD)
Time frame: 28 days after birth or 36 weeks'gestational age
the included neonate was diagnosed with BPD
Death
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
the included preterm infants were dead
5 secondary outcomes
the incidence of neonatal necrotizing enterocolitis(NEC)
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
the incidence of retinopathy of prematurity(ROP)
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
Intraventricular hemorrhage
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
composite mortality/BPD
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
the incidence of airleak
Time frame: 28 days after birth or 36 weeks'gestational age or before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Derived from this study: PubMed 41801204Li J, Liu K, Yang Q, Tan Q, Feng Z, Shi Y, Chen L, Li LJ. High-Frequency Oscillation vs Mechanical Ventilation for Neonatal Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e260268. doi: 10.1001/jamanetworkopen.2026.0268.
- Individual participant dataSharing planned: Yes. The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFOV and CMV in people with Acute Respiratory Distress Syndrome and Conventional Mechanical 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 5 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: finished, as of the sponsor's last update on 9 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of bronchopulmonary dysplasia (BPD) (time frame: 28 days after birth or 36 weeks'gestational age). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591796, which also lists 1 linked publication.
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 9 Jul 2025.