Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-05-21 @ 12:18 AM
Study NCT ID:
NCT03655457
Status:
UNKNOWN
Last Update Posted:
2018-12-11
First Post:
2018-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Surfaktant in Preterm Infants by Lung Ultrasound
Sponsor:
Zekai Tahir Burak Women's Health Research and Education Hospital
Organization:
Study Overview
Official Title:
Evaluation of the Efficacy of Different Surfactant Preparations in Preterm Infants by Lung Ultrasound
Status:
UNKNOWN
Status Verified Date:
2018-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: