Treatment of respiratory distress syndrome in preterm infants

A randomized trial comparing surfactant administration using InSurE technique and the minimally invasive surfactant therapy in preterm infants at the age of 28 to 36 weeks of gestation and respiratory distress syndrome

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20160523028008N8

Enrollment

112

Registered

2021-01-22

Start date

2019-11-22

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

Neonatal respiratory distress syndrome. Respiratory distress syndrome of newborn

Interventions

Intervention 1: Intervention group:Participants take 200 mg/kg surfactant (Curosurf Chiesi Farmaceutici, Parma, Italy)by MIST method. Neonatal intubation and who are receiving2000 mg/kg surfactants in

Eligibility

Sex/Gender

All

Age

1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Gestational age of 28-37 weeks With distress syndrome Requiring Fraction of inspired oxygen>40 Treatment with surfactant in less than 24 hours after birth

Exclusion criteria

Exclusion criteria: Suffering of congenital heart abnormalities APGAR score<5 Suffering from any congenital disease

Design outcomes

Primary

Measure	Time frame
Respiratory support. Timepoint: First week of birth. Method of measurement: Investigation of FIO2 and analysis of arterial blood gases.;Hospitalization duration. Timepoint: During hospitalization. Method of measurement: Review of infant medical records.;Mortality. Timepoint: During hospitalization. Method of measurement: Review of infant medical records.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamad Kazem Sabzehei

Hamedan University of Medical Sciences

Mk_sabzehei@yahoo.com+98 81 3838 0717

Outcome results

None listed

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