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Comparing Curosurf® and BLES® in treatment of respiratory distress syndrome

Comparing the efficacy of two natural surfactants, Curosurf® and BLES®, in treatment of respiratory distress syndrome in preterm neonates

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170513033941N54
Enrollment
160
Registered
2019-03-30
Start date
2018-04-21
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Respiratory distress syndrome of newborn. Respiratory distress of newborn

Interventions

Intervention 1: Intervention group 1: 200 mg/kg intratracheal Curosurf surfactant (Chiesi Farmaceutici, Parma, Italy). Intervention 2: Intervention group 2: 135 mg/kg intratracheal BLES surfactant (BL

Sponsors

Kashan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 1 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates with respiratory distress syndrome (RDS) gestational age of 32 weeks or less.

Exclusion criteria

Exclusion criteria: Exclusion criteria: congenital anomalies. Apgar score less than 4 at 5 minutes. neonates with meconium aspiration syndrome. prolonged premature rupture of membrane. parents declined to participate.

Design outcomes

Primary

MeasureTime frame
The number of surfactant injection. Timepoint: After the intervention. Method of measurement: Checklist.

Secondary

MeasureTime frame
Length of oxygen dependency. Timepoint: After the intervention. Method of measurement: Checklist.;Duration of hospital stay. Timepoint: After the intervention. Method of measurement: Checklist.;Complications of prematurity. Timepoint: After the intervention. Method of measurement: Checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mohammadreza Sharif

Kashan University of Medical Sciences

mrsharif.md@yahoo.com+98 31 5546 3378

Outcome results

None listed

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