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

Study Overview
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Brief Summary
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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).

Detailed Description
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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, remifentanil allowed an adequate level of sedation and analgesia as well as rapid recovery after discontinuation. The aim of the present study was to compares the intubation conditions among propofol and remifentanil versus midazolam and remifentanil in premature neonates with respiratory distress syndrome.

Official Title
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Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Drug: propofol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Minutes
Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: propofol|2mg/Kg IV in bolus before tracheal intubation|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until extubation after bolus dose as premedication for tracheal intubation |  | within the first 3 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of intubation with the combination of drugs used for premedication |  | within the first 2 days of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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propofol, midazolam, neonate, tracheal intubation