Status:
UNKNOWN
Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
Lead Sponsor:
Federal University of Minas Gerais
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
30-2 years
Phase:
PHASE4
Brief Summary
The aim of the study is to compare the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome. At the same tim...
Detailed Description
It has been demonstrated that remifentanil, due to it its very short context-sensitive, has an interesting potential for use in premature neonates with respiratory distress syndrome. Indeed, remifenta...
Eligibility Criteria
Inclusion
- Gestational age between 28-34 wk
- Clinical and radiological features compatible with respiratory distress syndrome that required elective tracheal intubation and surfactant therapy
- Hemodynamic stability before tracheal intubation
- Signature (parents) consent form
Exclusion
- The presence of major congenital malformations
- Birth weigh less than 1000 g
- Previous use of opioid or other sedative drug for any reason
- Previous tracheal intubation
- Hemodynamic instability before the indication of tracheal intubation
- Refuse of the parents to enroll the neonate in the study protocol
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00797160
Start Date
August 1 2008
End Date
December 1 2009
Last Update
November 25 2008
Active Locations (1)
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1
Department of Neonatology of Julia Kubitschek Hospital
Belo Horizonte, Minas Gerais, Brazil, 30620470