Respiratory DiseaseNCT04282369
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room
A study testing HHHFNC, NCPAP and NIPPV in people with Respiratory Disease and Respiratory Insufficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial summary
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress Read more about this study
- Who is it for?
- Ages Up to 2 hours
- Conditions the study is for
- Respiratory Disease, Respiratory Insufficiency
- What is being tested?
- HHHFNC, NCPAP and NIPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 18 Feb 2020to 15 Dec 2020
- 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 Up to 2 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- late preterm and term infants with respiratory distress
Who cannot join
- intubation for the respiratory distres.
- major abnormalities
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul, 34065
- Recruiting
Kanuni Sultan Suleyman Research and Training Hospital
Istanbul
ilker gönen, +905322054822, ilkergonen81@hotmail.com
About this study
Official title: Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Read the detailed description
In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.
- Conditions
- Respiratory Disease, Respiratory Insufficiency
- Being tested
- HHHFNC, NCPAP, NIPPV, NHFO
- Keywords
- respiratory distress, newborn, noninvasive ventilation
- Medical subject headings
- Respiration Disorders, Respiratory Insufficiency, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HHHFNCDevice
noninvasive ventilation modality
NCPAPDevice
noninvasive ventilation modality
NIPPVDevice
noninvasive ventilation modality
NHFODevice
noninvasive ventilation modality
| Study group | Role | What they receive |
|---|---|---|
| HHFNC | Active comparator | In this group patients will receive respiratory support by high flow nasal cannula. Receives: Device: HHHFNC |
| nCPAP | Active comparator | In this group patients will receive respiratory support by nasal CPAP. Receives: Device: NCPAP |
| nIPPV | Active comparator | In this group patients will receive respiratory support by nasal IPPV. Receives: Device: NIPPV |
| nHFO | Active comparator | In this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation. Receives: Device: NHFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Silverman Score
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
Measured: 6 months
Secondary outcomes (1)
N-PASS score
evaluation of the comfort of the four different noninvasive ventilation modes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start18 Feb 2020
- Primary completion1 Aug 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Gönen, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282369
- Sponsor's protocol ID
- 32342545
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 24 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
- ClinicalTrials.gov ID
- NCT04282369
- Acronym / sponsor ID
- 32342545
- Conditions
- Respiratory Disease, Respiratory Insufficiency
- Keywords
- respiratory distress, newborn, noninvasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 24 Feb 2020 (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.
Evaluation Of The Efficacy Of Four Different Non-invasive Ventilation Modes Performed In The Delivery Room In Late Preterm And Term Infants Wıth Respiratory Distress
Detailed description
In this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. HHFNC, NCPAP, NIPPV and NHFO modes are used for the respiratory distress of the late preterm and term babies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HHFNC | Active comparator | Device: HHHFNCIn this group patients will receive respiratory support by high flow nasal cannula. |
| nCPAP | Active comparator | Device: NCPAPIn this group patients will receive respiratory support by nasal CPAP. |
| nIPPV | Active comparator | Device: NIPPVIn this group patients will receive respiratory support by nasal IPPV. |
| nHFO | Active comparator | Device: NHFOIn this group patients will receive respiratory support by nasal high frequency oscillatory. ventilation. |
Who may qualify
- Ages
- Up to 2 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- late preterm and term infants with respiratory distress
Key exclusion criteria (2 listed)
- intubation for the respiratory distres.
- major abnormalities
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 |
|---|---|---|
| HHHFNCnoninvasive ventilation modality | Device | HHFNC |
| NCPAPnoninvasive ventilation modality | Device | nCPAP |
| NIPPVnoninvasive ventilation modality | Device | nIPPV |
| NHFOnoninvasive ventilation modality | Device | nHFO |
Primary outcome
Silverman Score
Time frame: 6 months
The respiratory status of the newborns will be evaluated with the scoring system defined by Silverman.
1 secondary outcome
N-PASS score
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HHHFNC, NCPAP and NIPPV in people with Respiratory Disease and Respiratory Insufficiency, run by Kanuni Sultan Suleyman Training and Research Hospital at 2 sites in Turkey (Türkiye).
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 1 inclusion and 2 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 24 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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 ilker gönen (+905322054822, ilkergonen81@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Silverman Score (time frame: 6 months). 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 24 Feb 2020.