Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound

Not Applicable

• Conditions: Lung Ultrasound Scores
• Interventions: Device: group 1 Poractant alfa; Device: group 2 beractant

• Registration Number: NCT03655457
• Lead Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital

Brief Summary

To compare the lung ultrasound scores after two different natural surfactant administration as a parameter reflecting lung inflation. Poractant alfa decreases lung ultrasound scores as efficient as beractant treatment

Detailed Description

Outcomes:

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.

Study Timeline

• Status Verified: 2018-03
• Study Start: 2018-03-21
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-08-30
• Study First Posted: 2018-08-31
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-01-30
• Study Completion: 2019-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 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.

Exclusion Criteria

• major congenital anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1 Poractant alfa	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 2 beractant	group 2 beractant	beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours

Primary Outcome Measures

Name	Time	Method
Lung usg scores	first days	Evaluation of Lung Usg Scores in infants treated with surfactant in the first six hours (Brat lung usg scores). Each item scored 0-3. (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.); - Higher values represent a worse outcome

Trial Locations

Locations (1)

Zekai Tahir Burak Matarnity Teaching; 🇹🇷 Ankara, Turkey