Status:
COMPLETED
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
Lead Sponsor:
Federal University of Minas Gerais
Conditions:
Respiratory Distress Syndrome
Eligibility:
All Genders
60-28 years
Phase:
PHASE4
Brief Summary
In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (...
Detailed Description
Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinic...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Gestational age between 28 and 34 wk
- Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.
- Exclusion criteria:
- The presence of major congenital malformations
- Birth weigh less than 1000g
- Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)
- Hemodynamic instability before the indication of tracheal intubation
- Refuse of the parents to enroll the neonate in the study protocol
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00391105
Start Date
April 1 2004
End Date
November 1 2005
Last Update
October 23 2006
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