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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Federal University of Minas Gerais.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of Minas Gerais
ClinicalTrials.gov Identifier:
NCT00797160
First received: November 20, 2008
Last updated: November 24, 2008
Last verified: August 2008

November 20, 2008
November 24, 2008
August 2008
December 2009   (final data collection date for primary outcome measure)
Time until extubation after bolus dose as premedication for tracheal intubation [ Time Frame: within the first 3 days of life ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00797160 on ClinicalTrials.gov Archive Site
Quality of intubation with the combination of drugs used for premedication [ Time Frame: within the first 2 days of life ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Respiratory Distress Syndrome
Drug: propofol
2mg/Kg IV in bolus before tracheal intubation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
up to 2 Days
No
Contact: Yerkes P Silva, PhD 00553199933384 yerkesps@uol.com.br
Contact: Márcia G Penido, MD 00553193047238 mgpenido@gmail.com
Brazil
 
NCT00797160
0011.0.287.000-08
Yes
Yerkes Pereira e Silva, Federal University of Minas Gerais
Federal University of Minas Gerais
Not Provided
Principal Investigator: Yerkes P Silva, PhD Federal University of Minas Gerais
Federal University of Minas Gerais
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP