the Efficacy and Safety of Intra-Tracheal Administration of Beraksurf in Comparison with Survanta and Curosurf in Neonates with RDS

Phase 3

Conditions: Respiratory distress syndrome.
Diseases of the respiratory system
J00–J99

Registration Number: IRCT20201213049705N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 90

Inclusion Criteria

Neonates with RDS
Premature infants with =25 to 34 weeks of gestation
Included during the first 8 hours of birth
required more than 30% FIO2

Exclusion Criteria

severe asphyxia at birth with a 5th minute Apgar score of less than 6
severe congenital anomalies such as heart disease and life-threatening abnormalities
Rupture of membranes for longer than 2-weeks
Multiple anomalies
septicemia,
respiratory failure for reasons other than RDS

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of infants with low oxygen index, which was considered to require more than 30% FIO2. Timepoint: monitoring the displayed amount on the ventilator's monitor every 4 hours for the first 72 hours and after that every 12 hours until the 28th day. Arterial blood gas (ABG) or venous blood gas (VBG) was taken every 4 to 6 hours in the first 24 hours and every 4 to 12 hours in the next 48 hours. Method of measurement: Ventilator device and taking venous and arterial blood and sending to emergency laboratory for ABG and VBG tests.

Secondary Outcome Measures

Name	Time	Method
Death. Timepoint: Every 2 to 4 hours for 28 days. Method of measurement: Checking the neonate's vital signs.;Duration of the mechanical ventilation. Timepoint: every 4 hours. Method of measurement: Checking the oxygen index and oxygen saturation percentages of the ventilator and ABG and VBG tests.;Sepsis. Timepoint: every 2 to 4 hours. Method of measurement: General malaise with tachypnea / hypotension / symptom instability / plus positive blood culture or CSF.;Bronchopulmonary dysplasia (BPD). Timepoint: every 4 hours. Method of measurement: Oxygen dependence after 28 days by checking the status of respiratory indices.