Neonatal Respiratory Distress SyndrometwinsNCT01926106
Nasal Intermittent Positive-Pressure Ventilation for Twin Infants With Respiratory Distress Syndrome
A study testing nIPPV and nCPAP in people with Neonatal Respiratory Distress Syndrome, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP. Read more about this study
- Who is it for?
- Ages 30 minutes to 6 hours
- Conditions the study is for
- Neonatal Respiratory Distress Syndrome
- What is being tested?
- nIPPV and nCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2012to 30 Jul 2017
- 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
- Twins
- Clinical diagnosis of mild-moderate respiratory distress syndrome
- requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95%
- a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)
Who cannot join
- pneumothorax
- pneumomediastinum
- surgical diseases
- cardiac diseases
- intraventricular hemorrage
- major congenital defects
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome
In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.
Read the detailed description
After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.
- Conditions
- Neonatal Respiratory Distress Syndrome
- Being tested
- nIPPV, nCPAP
- Keywords
- Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin, respiratory distress syndrome
- Medical subject headings
- Respiratory Distress Syndrome, Newborn, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nIPPVDevice
Also called nIPPV:Nasal Intermittent Positive Pressure Ventilation
one of the twins was randomly allocated to nIPPV
nCPAPDevice
Also called nCPAP:Nasal Continuous Positive Airway Pressure
another of the twins was allocated to nCPAP
| Study group | Role | What they receive |
|---|---|---|
| nIPPV | Experimental | the infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV) Receives: Device: nIPPV |
| nCPAP | Active comparator | the infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP) Receives: Device: nCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of intubation
Measured: 48h
Secondary outcomes (1)
incidence of BPD
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study start1 Jul 2012
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 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
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Long Chen, MD, Principal investigator, Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926106
- Sponsor's protocol ID
- twins
- Acronym
- twins
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive-Pressure Ventilation vs Nasal Continuous Positive Airway Pressure for Twin Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01926106
- Acronym / sponsor ID
- twins / twins
- Conditions
- Neonatal Respiratory Distress Syndrome
- Keywords
- Nasal Intermittent Positive-Pressure Ventilation, Nasal Continuous Positive Airway Pressure, twin, respiratory distress syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 20 Aug 2013 (estimated)
- 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.
In the present study, we hypothesized that primary mode nIPPV initiated shortly after birth would decrease the incidence of intubation or death in twin infants when compared to nCPAP.
Detailed description
After inclusion of eligible twins infants,one of the twins was supported by nCPAP and another nIPPV.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nIPPV | Experimental | Device: nIPPVthe infants in the arm were supported by Nasal Intermittent Positive-Pressure Ventilation(nIPPV) |
| nCPAP | Active comparator | Device: nCPAPthe infants in the arm were supported by Nasal Continuous Positive Airway Pressure(nCPAP) |
Who may qualify
- Ages
- 30 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Twins
- Clinical diagnosis of mild-moderate respiratory distress syndrome
- requiring a fraction of inspired oxigen (FiO2 ) <0.40 to keep oxygen saturation of 90%-95%
- a chest X-ray suggestive of early stage hyaline membrane disease, (i.e. mild microgranulia and air bronchogram)
Key exclusion criteria (6 listed)
- pneumothorax
- pneumomediastinum
- surgical diseases
- cardiac diseases
- intraventricular hemorrage
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 |
|---|---|---|
| nIPPVAlso: nIPPV:Nasal Intermittent Positive Pressure Ventilationone of the twins was randomly allocated to nIPPV | Device | nIPPV |
| nCPAPAlso: nCPAP:Nasal Continuous Positive Airway Pressureanother of the twins was allocated to nCPAP | Device | nCPAP |
Primary outcome
incidence of intubation
Time frame: 48h
1 secondary outcome
incidence of BPD
Time frame: 1 month
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 7 Dec 2017.
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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.
Long Chen, MD principal investigator
Department of Pediatrics, Daping Hospital, Research Institute of Surgery, 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 nIPPV and nCPAP in people with Neonatal Respiratory Distress Syndrome, 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 6 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 7 Dec 2017. 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?
incidence of intubation (time frame: 48h). 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 7 Dec 2017.