Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound
NCT ID: NCT03655457
Last Updated: 2018-12-11
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
64 participants
INTERVENTIONAL
2018-03-21
2019-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Improvement of Lung usg scores after surfactanct and the difference between groups at different time points (2nd and 6hr).
Secondary outcome:
The correlation between lung usg scores and clinical scores (silverman scores), FiO2 and PCO2 levels, failure of weaning to noninvasive ventilation after surfactant Preterm infants of 32 gestational weeks and below, who admit to the NICU with signs of respiratory distress, treated with non invasive or mechanical ventilation and require surfactant treatment in 6 hours of life will be enrolled.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
group 1 Poractant alfa
Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours
group 1 Poractant alfa
Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
group 2 beractant
beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours
group 2 beractant
lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
group 1 Poractant alfa
Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
group 2 beractant
lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
1 Hour
6 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.
Evrim Alyamaç Dizdar, MD
Role: STUDY_DIRECTOR
zekai tahir burak matarnity teaching hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zekai Tahir Burak Matarnity 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.
Davut Bozkaya, MD
Role: primary
Şebnem Özyer, MD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22032018
Identifier Type: -
Identifier Source: org_study_id