Evaluation of the effect of Beraksurf and Cursorf in patients with respiratory distress

Comparison of therapeutic effects of Iranian surfactant (Beraksurf) with Cursorf in premature infants with respiratory distress admitted to the neonatal intensive care unit of Hafez and Namazi hospitals in Shiraz in 1400

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120126008827N3

Enrollment

100

Registered

2022-01-09

Start date

2021-12-22

Completion date

Unknown

Last updated

2022-01-11

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

Conditions

respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group 1: In this group, 50 neonates with RDS diagnosis will receive intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 2.5 cc/ kg (200 mg/kg) every 6-12 hour

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Gestational age 30% for keeping o2 saturation 92-95% that measured by pulse oximetry

Exclusion criteria

Exclusion criteria: Patients with congenital disease and anomalies Receiving two types of surfactant due to lack or shortage of the drug Patients need operation Neonates with congenital heart or lung disease or abdominal pathology

Design outcomes

Primary

Measure	Time frame
Treatment of respiratory distress syndrome. Timepoint: evaluate respiratory condition of neonates at birth and 2, 6,12,18,24,36,48 and 72 hour after birth. Method of measurement: Beraksurf case report form.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKhadijeh Sadat Najib

Shiraz University of Medical Sciences

nzahrasan@yahoo.com+98 71 1647 4298

Outcome results

None listed

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