Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)

• Status: Unknown status
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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 time, to show the group of drugs that could let the neonates with no residual sedation after the use of surfactant (the possibility of the premature neonates to be readily extubated after the use of surfactant).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federal University of Minas Gerais
• Treatments: Midazolam; Propofol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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