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
Recruitment status was Recruiting
Sponsor:
Federal University of Minas Gerais
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 20, 2008 | ||||||||
| Last Updated Date | November 24, 2008 | ||||||||
| Start Date ICMJE | August 2008 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00797160 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS) | ||||||||
| Official Title ICMJE | Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome | ||||||||
| 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 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). |
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| 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, 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Respiratory Distress Syndrome | ||||||||
| Intervention ICMJE | Drug: propofol
2mg/Kg IV in bolus before tracheal intubation |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 2 Days | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00797160 | ||||||||
| Other Study ID Numbers ICMJE | 0011.0.287.000-08 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Yerkes Pereira e Silva, Federal University of Minas Gerais | ||||||||
| Study Sponsor ICMJE | Federal University of Minas Gerais | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Federal University of Minas Gerais | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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