IRCT201310164113N7
Completed
Phase 2
Remifentanil versus Fentanyl for pain control during elective endotracheal intubation for surfactant administration in preterm neonates
Vice Chancellor for Research of Tabriz University of of Medical Sciences0 sites32 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Respiratory distress syndrome of newborn.
- Sponsor
- Vice Chancellor for Research of Tabriz University of of Medical Sciences
- Enrollment
- 32
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm newborns with gestational age between 28 to 34 weeks and 6 days from last menstrual period of mother who was born in Alzahra teaching hospital of Tabriz; clinical criteria of respiratory distress (consists of: tachypnea, grunting, inter coastal retraction and increased oxygen requirement) and radio graphic findings of Respiratory Distress Syndrome; need for surfactant treatment by INSURE (Intubate, Surfactant, Extubate) procedure.
- •Exclusion criteria: other causes of respiratory distress in newborns; second or third degree AV heart block; use of fentanyl during 4 hours from delivery; severe asphyxia (APGAR score under 5 at 5th minutes after delivery ); impaired consciousness level; major congenital anomalies; difficult intubation due to facial anomalies; more than three attempts for intubation.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Not specified
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