NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation
NCT ID: NCT02842190
Last Updated: 2019-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
140 participants
INTERVENTIONAL
2016-01-15
2019-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
NCT02901652
Nasal Intermittent Positive Pressure Ventilation During Neonatal Intubation
NCT06549283
Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome
NCT03226977
A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
NCT03298035
Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants
NCT02887846
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NIPPV
NIPPV after ekstubation
NIPPV
after ekstubation
BIPAP
BIPAP after ekstubation
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NIPPV
after ekstubation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Day
14 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zekai Tahir Burak Women's Health Research and Education Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
nilüfer okur
NEONATOLOGY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Serife Suna Oguz
Role: STUDY_DIRECTOR
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Nurdan Uras
Role: STUDY_CHAIR
Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Recruiting
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zekai Tahir Burak Maternity Teaching hospital
Ankara, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Fatmanur Sari, Assosiace professor
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NIPPV-2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.