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

Overview

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).

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2009

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.

Interventions

  • Drug: propofol
    • 2mg/Kg IV in bolus before tracheal intubation

Clinical Trial Outcome Measures

Primary Measures

  • Time until extubation after bolus dose as premedication for tracheal intubation
    • Time Frame: within the first 3 days of life

Secondary Measures

  • Quality of intubation with the combination of drugs used for premedication
    • Time Frame: within the first 2 days of life

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 30 Minutes

Maximum Age: 2 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Yerkes Pereira e Silva, Federal University of Minas Gerais
  • Overall Official(s)
    • Yerkes P Silva, PhD, Principal Investigator, Federal University of Minas Gerais
  • Overall Contact(s)
    • Yerkes P Silva, PhD, 00553199933384, yerkesps@uol.com.br

References

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.