Intubation ComplicationNCT02842190
NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
A study testing NIPPV in people with Intubation Complication and PreTerm Birth, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Intubation Complication, PreTerm Birth
- What is being tested?
- NIPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2016to 15 Oct 2019
- 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 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mechanically ventilated preterm infants with birthweight ≤1250 g
Who cannot join
- Infants with major congenital malformations, neuromuscular disease and lack of parental consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Maternity Teaching hospital
Ankara
Fatmanur Sari, Assosiace professor
About this study
Official title: Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.
Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.
Read the detailed description
In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.
Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.
Extubation failure was defined as: development of respiratory acidosis (blood gases with pH < 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 < 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.
Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.
The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.
- Conditions
- Intubation Complication, PreTerm Birth
- Being tested
- NIPPV
- Keywords
- Neonatal, NIPPV, BIPAP, Extubation failure
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVDevice
after ekstubation
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Active comparator | NIPPV after ekstubation Receives: Device: NIPPV |
| BIPAP | No intervention | BIPAP after ekstubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of extubation failure
Measured: within 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study start15 Jan 2016
- Primary completion30 Jun 2017
- Study completion15 Oct 2019 (estimated)
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 Intubation ComplicationStudies 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
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nilüfer okur, Zekai Tahir Burak Women's Health Research and Education Hospital
- Investigators
- Serife Suna Oguz, Study director, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. RecruitingNurdan Uras, Study chair, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842190
- Sponsor's protocol ID
- NIPPV-2016
- Status last verified
- Oct 2019
- First submitted
- 20 Jul 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Okur N, Buyuktiryaki M, Sari FN, Dizdar EA, Oguz SS. Ventilator-delivered nasal intermittent positive pressure ventilation versus nasal biphasic positive airway pressure following extubation in infants </=1250 g birth weight: a randomized trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):752-758. doi: 10.1080/14767058.2020.1731462. Epub 2020 Feb 27.
PubMed 32106721
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation in Infants ≤ 1250 g Birthweight
- ClinicalTrials.gov ID
- NCT02842190
- Acronym / sponsor ID
- NIPPV-2016
- Conditions
- Intubation Complication, PreTerm Birth
- Keywords
- Neonatal, NIPPV, BIPAP, Extubation failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- 15 Jan 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 15 Oct 2019 (estimated)
- First posted
- 22 Jul 2016 (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.
Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants.
Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.
Detailed description
In this study , mechanically ventilated preterm infants with birthweight ≤1250 g will screen for eligibility. Infants with major congenital malformations, neuromuscular disease and lack of parental consent were excluded. Enrolled infants will randomize into two study groups (NIPPV group and BIPAP group) following the decision to extubate by using sealed opaque envelopes. Extubation criteria are; loaded with caffeine according to standard clinical protocol, satisfactory blood gases (pH of more than 7.25), mean airway pressure of 7 cm water or less, fractional inspired oxygen concentration of 35 % or less and good respiratory effort.
Non-invasive respiratory support will deliver using the device of SLE 5000 (Specialised Laboratory Equipment, South Croydon, United Kingdom) in NIPPV group and infant flow- deriver device (Viasys Corp, Care Fusion, CA) in BIPAP group. The short binasal prongs will use as interface. The initial ventilator parameters for NIPPV were: PIP levels set 2 cm H2O above the pre-extubation PIP, PEEP: 5 cm H2O, rate the same as was being given before extubation and for BiPAP were: lower CPAP levels 4 to 6 cmH2O (maximum 7 cmH2O) and higher CPAP levels 8 to 9 cmH2O (maximum 10 cmH2O), Thigh 0.5-0.6 second, and a pressure exchange rate of 20-30/ minute, with the lowest adjusted FiO2 to maintain an oxygen saturation of 90% to 95%.
Extubation failure was defined as: development of respiratory acidosis (blood gases with pH < 7.2 and PaCO2> 60 mmHg), or hypoxemia (blood gases with PaO2 < 50 mmHg despite oxygen supplementation of 60 percent), or severe apnea requiring mask ventilation.
Surfactant requirement is goingto evaluate in all infants after NICU admission. Poractant alfa was administered if necessary.
The primary end-point, rate of extubation failure within 96 hours following first extubation, will compared between the groups. Short and long-term neonatal outcomes will also evaluate.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Active comparator | Device: NIPPVNIPPV after ekstubation |
| BIPAP | No intervention | –BIPAP after ekstubation |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Mechanically ventilated preterm infants with birthweight ≤1250 g
Key exclusion criteria (1 listed)
- Infants with major congenital malformations, neuromuscular disease and lack of parental consent
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 |
|---|---|---|
| NIPPVafter ekstubation | Device | NIPPV |
Primary outcome
Rate of extubation failure
Time frame: within 96 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 32106721Okur N, Buyuktiryaki M, Sari FN, Dizdar EA, Oguz SS. Ventilator-delivered nasal intermittent positive pressure ventilation versus nasal biphasic positive airway pressure following extubation in infants </=1250 g birth weight: a randomized trial. J Matern Fetal Neonatal Med. 2022 Feb;35(4):752-758. doi: 10.1080/14767058.2020.1731462. Epub 2020 Feb 27.
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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.
Serife Suna Oguz study director
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Nurdan Uras study chair
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
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 in people with Intubation Complication and PreTerm Birth, run by Zekai Tahir Burak Women's Health Research and Education Hospital 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 1 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 4 Oct 2019. 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 NİLUFER OKUR, dr (+905065360059, n.matur@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of extubation failure (time frame: within 96 hours). 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 NCT02842190, 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 4 Oct 2019.