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Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of neonatal respiratory distress syndrome

Comparison of efficacy and safety of two natural surfactants, Curosurf and Survanta in treatment of respiratory distress syndrome: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015071017413N12
Enrollment
112
Registered
2015-09-01
Start date
2014-05-22
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: After intubation the group one infants were received 100 mg/kg Curosurf as soon as possible after randomization. Intervention 2: After intubation the group two infants were received 10
Treatment - Drugs
After intubation the group one infants were received 100 mg/kg Curosurf as soon as possible after randomization.
After intubation the group two infants were received 100 mg/kg Survanta as soon as possible after randomization.

Sponsors

Baqiyatallah University of Medical Sciences, Deputy of Research
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: Neonates were born with RDS diagnosis in Najmieh and Baqiyatallah hospitals; weight of 750 to 1750 gr; gestational age less than 35 weeks; O2 saturation 85% to 96%; signed informed consent by parents; and age = 6 hours at the time of randomization. Exclusion criteria: Congenital heart diseases and other life threatening congenital anomalies; respiratory failure due to other causes, 5 minute Apgar score = 3; proven fetal lung maturity profile from amniocentesis; prior treatment with exogenous surfactant; prolonged (= 3 weeks) rupture of membranes; untreated hypotension or hypoglycemia; use of high-frequency ventilation prior to first dose of surfactant; and severe grades of intra-ventricular hemorrhage (grades III or IV) prior to surfactant.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Needing second surfactant dose. Timepoint: 12 to 24 hours after the first surfactant dose. Method of measurement: Yes / No.;Hospital stay. Timepoint: At the time of discharge. Method of measurement: Days.;Mortality. Timepoint: During the hospital stay. Method of measurement: Dead / alive.;Needing nasal continuous positive airway pressure. Timepoint: During the hospital stay. Method of measurement: Yes / No.;Needing endotracheal tube. Timepoint: During the hospital stay. Method of measurement: Yes / No.;RDS-related complications. Timepoint: During the hospital stay. Method of measurement: Yes / No.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamidreza Karimi-Sari

Students’ Research Committee (SRC), Baqiyatallah University of Medical Sciences, Tehran, IR Iran

dr.karimih@yahoo.com+98 21 8126 4354

Outcome results

None listed

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