Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Lung usg scores
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Hour to 6 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: group 1 Poractant alfa (Device)
group 2 beractant
beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours
Intervention: group 2 beractant (Device)
Outcomes
Primary Outcomes
Lung usg scores
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported