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Comparison of efficacy & safety of Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)

Comparison of efficacy & safety of intratracheal Beraksurf with Survanta and Curosurf in preterm newborns with Respiratory distress syndrome (RDS)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200529047594N1
Enrollment
90
Registered
2020-06-08
Start date
2020-01-22
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Respiratory Distress Syndrome (RDS). Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group: Includes premature neonates with RDS diagnosis. In this group, samples (n=30) received intratracheal Beraksurf (produced by Tekzima, Iran) at a dose of 4 cc / kg ev

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 2 Days

Inclusion criteria

Inclusion criteria: Parents consent to participate study premature neonates with a gestational age of less than 34 weeks premature neonates with diagnosis of RDS and candidates for surfactant A maximum of 8 hours have elapsed since the birth

Exclusion criteria

Exclusion criteria: No parents consent to participate study Newborns with congenital heart diseases and other life threatening congenital anomalies. Adverse drug effects

Design outcomes

Primary

MeasureTime frame
Improved outcomes in RDS. Timepoint: Before intervention and after intervention. Method of measurement: the need for mechanical ventilation, Venous Blood Gas.;Mortality. Timepoint: During the hospital stay. Method of measurement: Dead / alive.;Drug-related complications. Timepoint: During the hospital stay. Method of measurement: Yes/No.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiknaz Kabiri

Iran University of Medical Sciences

kabiri.n@iums.ac.ir+98 21 2304 6253

Outcome results

None listed

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