Comparison of Two Different NCPAP Methods in Preterm Infants With Respiratory Distress Syndrome
NCT ID: NCT03400670
Last Updated: 2019-07-16
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
400 participants
INTERVENTIONAL
2017-01-05
2020-02-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Predictors for Nasal Intermittent Positive Pressure Ventilation Failure for Premature Infants With Respiratory Distress Syndrome
NCT05260424
Surfactant Versus Nasal Continuous Positive Airway Pressure (nCPAP) for Respiratory Distress Syndrome in the Newborn ≥ 35 Weeks of Gestation
NCT01306240
Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
NCT01996670
Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods
NCT04505176
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Under non-invasive respiratory support, in case of FiO2 is ≥ 0.40, surfactant will be given as early rescue therapy by means of non-invasive method (by using a thin catheter - take care method- while spontaneous breathing continues) in order to keep target oxygen saturation between 90-95 %. The second dose of surfactant will be given 6 hours after the first dose by means on non-invasive method in order to keep target oxygen saturation between 90-95 % in case of FiO2 need is ≥ 0.30.
Non-invasive respiratory support failure is set as follows:
* FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
* Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
* Persistent acidosis; presence of pH \< 7.20 and PCO2 \> 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
* Severe respiratory distress,
* Pulmonary haemorrhage and cardiopulmonary arrest.
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
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ventilator NCPAP
neonatal ventilator (SLE; Specialised Laboratory Equipment, UK) PEEP: 5 cmH2O
ventilator NCPAP
infants will be randomized into two different NCPAP groups
Infant Flow-driver NCPAP
infant flow-driver device (Infant Flow System, Viasys Corp., USA) PEEP:5-8 cmH2O, This group receive variable flow
ventilator NCPAP
infants will be randomized into two different NCPAP groups
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ventilator NCPAP
infants will be randomized into two different NCPAP groups
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Presence of cardiovascular instability
* Intubation at admission to the NICU
* Consent not provided or refused
1 Hour
2 Hours
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.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suna Oğuz
Role: STUDY_DIRECTOR
Zekai Tahir Burak Women's Health Research and Education Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zekai Tahir Burak Maternity Teaching
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
02082019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.