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

Evaluation of the Efficacy and Safety of Intra-Tracheal Administration of Beraksurf in Comparison with Survanta and Curosurf in Neonates with Respiratory Distress Syndrome: A Three-Arm Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201213049705N1

Enrollment

Registered

2021-02-16

Start date

2019-10-07

Completion date

Unknown

Last updated

2021-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress syndrome. Diseases of the respiratory system

Interventions

Intervention 1: Intervention group: Beraksurf group. In this group, Beraksurf ampoules made by Tekzima Daru Company (Iran) in a dose of 4cc/kg will be injected intratracheally. Injections can be injec

Eligibility

Sex/Gender

All

Age

1 Days to 2 Months

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Afsaneh Alimohammadi

Tehran University of Medical Sciences

afsanehalimohamadi788693@gmail.com+98 21 6119 2052

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026