Nasal High Frequency Oscillation VentilationNCT03206489
Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Twins Infants
A study testing noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) in people with Nasal High Frequency Oscillation Ventilation, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome Read more about this study
- Who is it for?
- Ages 30 minutes to 6 hours
- Conditions the study is for
- Nasal High Frequency Oscillation Ventilation
- What is being tested?
- noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (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
- 1 Aug 2017to 30 Jun 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 30 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) is from 26 to 37 weeks;
- Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- Respiratory distress syndrome Silverman score >5;
- Informed parental consent has been obtained.
Who cannot join
- Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
- Major congenital malformations or complex congenital heart disease;
- Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
- Cardiopulmonary arrest needing prolonged resuscitation;
- transferred out of the neonatal intensive care unit without treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Chen Long, PhD,MD, 13508300283, petshi530@vip.163.com
About this study
Official title: Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome
Read the detailed description
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.
- Being tested
- noninvasive high-frequency ventilation (nHFOV), nasal continuous positive airway pressure (nCPAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
noninvasive high-frequency ventilation (nHFOV)Device
noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome
nasal continuous positive airway pressure (nCPAP)Device
nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome
| Study group | Role | What they receive |
|---|---|---|
| nHFOV | Experimental | noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome Receives: Device: noninvasive high-frequency ventilation (nHFOV) |
| nCPAP | Active comparator | nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome Receives: Device: nasal continuous positive airway pressure (nCPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation
the baby is re-intubated.
Measured: during the first 7 days after birth
Secondary outcomes (2)
Bronchopulmonary dysplasia(BPD)
BPD was defined according to the National Institutes of Health consensus definition
Measured: at a post-menstrual age of 36 weeks or at discharge
Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development at 2 months old and 2 years old
Measured: 30 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start1 Aug 2017
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal High Frequency Oscillation VentilationStudies 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
- noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
- 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
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03206489
- Sponsor's protocol ID
- twins with HFO
- Status last verified
- Oct 2022
- First submitted
- 26 Jun 2017
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High Frequency Oscillation for Respiratory Distress Syndrome in Preterm Twins Infants
- ClinicalTrials.gov ID
- NCT03206489
- Acronym / sponsor ID
- twins with HFO
- 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
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Jul 2017 (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.
The investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nHFOV) or nasal continuous positive airway pressure (nCPAP) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome
Detailed description
Invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. Various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (BPD). The aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (NHFOV) and nasal continuous positive airway pressure (NCPAP) in preterm twins infants as the primary mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) are used as primary mode of ventilation in preterm twins infants with RDS
| Arm | Type | Receives |
|---|---|---|
| nHFOV | Experimental | Device: noninvasive high-frequency ventilation (nHFOV)noninvasive high-frequency ventilation (nHFOV) is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome |
| nCPAP | Active comparator | Device: nasal continuous positive airway pressure (nCPAP)nasal continuous positive airway pressure (nCPAP) is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome |
Who may qualify
- Ages
- 30 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age (GA) is from 26 to 37 weeks;
- Diagnosis of respiratory distress syndrome. The diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- Respiratory distress syndrome Silverman score >5;
- Informed parental consent has been obtained.
Key exclusion criteria (5 listed)
- Severe respiratory distress syndrome requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation7;
- Major congenital malformations or complex congenital heart disease;
- Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
- Cardiopulmonary arrest needing prolonged resuscitation;
- transferred out of the neonatal intensive care unit without treatment.
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 |
|---|---|---|
| noninvasive high-frequency ventilation (nHFOV)noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome | Device | nHFOV |
| nasal continuous positive airway pressure (nCPAP)nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome | Device | nCPAP |
Primary outcome
intubation
Time frame: during the first 7 days after birth
the baby is re-intubated.
2 secondary outcomes
Bronchopulmonary dysplasia(BPD)
Time frame: at a post-menstrual age of 36 weeks or at discharge
Bayley Scales of Infant Development
Time frame: 30 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Individual participant dataSharing planned: No
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.
Shi Yuan, PhD,MD study director
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing noninvasive high-frequency ventilation (nHFOV) and nasal continuous positive airway pressure (nCPAP) in people with Nasal High Frequency Oscillation 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: status not confirmed, as of the sponsor's last update on 25 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 Long, MD (13883559467 ext. 86, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation (time frame: during the first 7 days after birth). 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 25 Oct 2022.