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

Primary Purpose

Respiratory Distress Syndrome

Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
propofol
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Distress Syndrome focused on measuring propofol, midazolam, neonate, tracheal intubation

Eligibility Criteria

30 Minutes - 2 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Neonatology of Julia Kubitschek HospitalRecruiting

Outcomes

Primary Outcome Measures

Time until extubation after bolus dose as premedication for tracheal intubation

Secondary Outcome Measures

Quality of intubation with the combination of drugs used for premedication

Full Information

First Posted
November 20, 2008
Last Updated
November 24, 2008
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT00797160
Brief Title
Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)
Official Title
Propofol and Remifentanil Versus Midazolam and Remifentanil as Premedication Allowing Very Early Extubation After Surfactant Treatment in Preterm Neonates With Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
Keywords
propofol, midazolam, neonate, tracheal intubation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
propofol
Intervention Description
2mg/Kg IV in bolus before tracheal intubation
Primary Outcome Measure Information:
Title
Time until extubation after bolus dose as premedication for tracheal intubation
Time Frame
within the first 3 days of life
Secondary Outcome Measure Information:
Title
Quality of intubation with the combination of drugs used for premedication
Time Frame
within the first 2 days of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Minutes
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yerkes P Silva, PhD
Phone
00553199933384
Email
yerkesps@uol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Márcia G Penido, MD
Phone
00553193047238
Email
mgpenido@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yerkes P Silva, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neonatology of Julia Kubitschek Hospital
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30620470
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Márcia G Penido, MD
Phone
00553193047238
Email
mgpenido@gmail.com
First Name & Middle Initial & Last Name & Degree
Márcia G Penido, MD

12. IPD Sharing Statement

Citations:
Citation
SILVA,Y.P. et al. Morphine versus remifentanil for intubating preterm neonates. Short report.Archives of Disease in Childhood Fetal & Neonatal Edition;92:4.2007. Dani C, Bertini G, Pezzati M, et al. Early Extubation and Nasal Continuous Positive Airway Pressure After Surfactant Treatment for Respiratory Distress Syndrome Among Preterm Infants <30 Weeks' Gestation. Pediatrics 2004; 113:560-563. Carbajal R, Eble B, Anand KJS. Premedication for Tracheal Intubation in Neonates: Confusion or Controversy? Seminars in Perinatology 2007; 31:309-317. Silva YP, Gomez RS, Marcatto JO, et al. Early awakening and extubation with remifentanil in ventilated premature neonates. Pediatric Anesthesia 2008; 18:176-183. Welzing L, Roth B. Experience with remifentanil in neonates and infants. Drugs 2006; 66(10):1339-1350.
Results Reference
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Propofol Versus Midazolam as Premedication for Preterm Neonates With Respiratory Distress Syndrome (RDS)

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