Bronchopulmonary DysplasiaNIVNCT01989442
Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
A study testing binasal prongs and nasal mask in people with Bronchopulmonary Dysplasia, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer. The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- binasal prongs and nasal mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2013to Jan 2015
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit
Who cannot join
- who are intubated in delivery room or neonatal intensive care unit before randomization
- with congenital anomaly
- patients who require NIV more than 3 days
Trial locations and contacts
1 site in 1 country.
Ankara University contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara University
Ankara, Ankara, 06300
Ufuk Cakir, 905058581781, drufukcakir@hotmail.com
About this study
Official title: Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.
The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.
Read the detailed description
Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- binasal prongs, nasal mask
- Keywords
- cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
binasal prongsDevice
Also called viasys healthcare infant flow system- binasal prongs
patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support
nasal maskDevice
Also called viasys healthcare infant flow system-nasal mask
patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support
| Study group | Role | What they receive |
|---|---|---|
| Nasal Mask | Experimental | patients who receive NIV by nasal mask interface after randomization Receives: Device: nasal mask |
| nasal prong | Active comparator | patients who receive NIV by nasal prongs as interface after randomization Receives: Device: binasal prongs |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of NIV
patients who require endotracheal intubation after NIV treatment
Measured: 1 year
Secondary outcomes (1)
ventilation duration
both NIV and mechanical ventilation durations will be evaluated
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2014
- Study completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ufuk Cakir, Ankara University
- Investigators
- Saadet ARSAN, Professor, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989442
- Sponsor's protocol ID
- Map-NIV Trial
- Acronym
- NIV
- Status last verified
- Jan 2015
- First submitted
- 15 Nov 2013
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29.
PubMed 23897911Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22.
PubMed 23090339
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nasal Mask and Prong Use in Non-invasive Ventilation for Newborns
- ClinicalTrials.gov ID
- NCT01989442
- Acronym / sponsor ID
- NIV / Map-NIV Trial
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- cpap failure, bronchopulmonary dysplasia, nasal trauma, ventilation duration, non-invasive ventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2015 (estimated)
- First posted
- 21 Nov 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.
The study aims to investigate efficacy and safety of nasal mask and prongs used in non-invasive ventilation in newborns by using esophageal pressure transducer.
The parameters including ventilation duration, hospitalization duration, pulmonary outcomes and side effects will be evaluated.
Detailed description
Although it seems as more non-invasive there is still lack of data especially on efficacy of nasal mask use in NIV for newborns. By using esophageal pressure transducers we will evaluate the pressure supplied by the ventilation mode and compare it with more commonly used nasal prongs. The investigators will test the hypothesis of equivalence of nasal mask in comparison to prongs with better safety parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Mask | Experimental | Device: nasal maskpatients who receive NIV by nasal mask interface after randomization |
| nasal prong | Active comparator | Device: binasal prongspatients who receive NIV by nasal prongs as interface after randomization |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all newborns who require NIV as first line treatment as respiratory support in delivery room or neonatal intensive care unit
Key exclusion criteria (3 listed)
- who are intubated in delivery room or neonatal intensive care unit before randomization
- with congenital anomaly
- patients who require NIV more than 3 days
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 |
|---|---|---|
| binasal prongsAlso: viasys healthcare infant flow system- binasal prongspatients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support | Device | nasal prong |
| nasal maskAlso: viasys healthcare infant flow system-nasal maskpatients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support | Device | Nasal Mask |
Primary outcome
failure of NIV
Time frame: 1 year
patients who require endotracheal intubation after NIV treatment
1 secondary outcome
ventilation duration
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
- Background: PubMed 23897911McCarthy LK, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. A randomized trial of nasal prong or face mask for respiratory support for preterm newborns. Pediatrics. 2013 Aug;132(2):e389-95. doi: 10.1542/peds.2013-0446. Epub 2013 Jul 29.
- Background: PubMed 23090339Kieran EA, Twomey AR, Molloy EJ, Murphy JF, O'Donnell CP. Randomized trial of prongs or mask for nasal continuous positive airway pressure in preterm infants. Pediatrics. 2012 Nov;130(5):e1170-6. doi: 10.1542/peds.2011-3548. Epub 2012 Oct 22.
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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.
Ankara University contact
Saadet ARSAN, Professor principal investigator
Ankara 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 binasal prongs and nasal mask in people with Bronchopulmonary Dysplasia, run by Ankara University at 1 site 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 3 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 15 Jan 2015. 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 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 Ankara University, or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
failure of NIV (time frame: 1 year). 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 NCT01989442, which also lists 2 linked publications.
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 15 Jan 2015.