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Comparing the efficacy of surfactant administration by laryngeal mask airway (LMA) and endotracheal intubation

Comparing the efficacy of surfactant administration by laryngeal mask airway (LMA) and endotracheal intubation in neonatal respiratory distress syndrome

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201411183915N12
Enrollment
70
Registered
2014-11-28
Start date
2014-11-21
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

Interventions

Intervention 1: Intervention group: administration of surfactant 4cc/kg survanta in 4 divided dose via laryngeal mask after receiving 1-2 µ/kg intravenous fentanyl. Intervention 2: Control group: admi
Treatment - Drugs
Intervention group: administration of surfactant 4cc/kg survanta in 4 divided dose via laryngeal mask after receiving 1-2 µ/kg intravenous fentanyl
Control group: administration of surfactant 4cc/kg survanta in 4 divided dose via endotracheal tube after receiving 1-2 µ/kg intravenous fentanyl

Sponsors

Research Vice Chancellor for Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: gestation age 33-37 weeks; confirmed diagnosis of respiratory distress syndrome according to clinical and radiological findings; treatment with surfactant Exclusion criteria: major congenital anomalies; congenital heart disease; cranio-facial anomalies; esophageal atresia; birth weight less than 1800 grams

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Reduced needed FiO2 to maintain adequate oxygenation. Timepoint: Before and one hour after surfactant therapy. Method of measurement: Determination of needed Fio2 in blender and by pulse oxymetry.

Secondary

MeasureTime frame
Need for intubation and assisted ventilation. Timepoint: Till 3 days after treatment. Method of measurement: Pulse oxymetry and blood gas analysis.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Reza Radfar

Al Zahra Hospital

gharehbaghimm@yahoo.com+98 41 3553 9161

Outcome results

None listed

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