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

Zekai Tahir Burak Women's Health Research and Education Hospital

Status: Unknown

Conditions: Lung Ultrasound Scores

Treatments: Device: group 1 Poractant alfa; Device: group 2 beractant

Study type: Interventional

Funder types: Other

Identifiers

NCT03655457

22032018

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

group 1 Poractant alfa

Experimental group

Description:

Poractant alfa generic name: curosurf 120 and 240 mg flk dosage: 200 mg/ kg intratracheal application frequency and duration: in the first two hours

Treatment:

Device: group 1 Poractant alfa

group 2 beractant

Active Comparator group

Description:

beractant generic name: survanta 8 cc flk dosage: 4 cc/ kg intratracheal application frequency and duration: in the first two hours

Treatment:

Device: group 2 beractant