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

NCT00797160 | Unknown Phase 4 DMC

• 1 other identifier: 0011.0.287.000-08
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Respiratory Distress Syndrome

Keywords

propofol; midazolam; neonate; tracheal intubation

Outcome Measures

Primary Outcomes (1)

• Time until extubation after bolus dose as premedication for tracheal intubation

  within the first 3 days of life

Secondary Outcomes (1)

• Quality of intubation with the combination of drugs used for premedication

  within the first 2 days of life

Interventions

propofol DRUG

2mg/Kg IV in bolus before tracheal intubation

Eligibility Criteria

• Age: 30 Minutes - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Department of Neonatology of Julia Kubitschek Hospital

Belo Horizonte, Minas Gerais, 30620470, Brazil

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Propofol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Yerkes P Silva, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yerkes P Silva, PhD

CONTACT

00553199933384; yerkesps@uol.com.br

Márcia G Penido, MD

CONTACT

00553193047238; mgpenido@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 25, 2008
• Study Start: August 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 25, 2008

Record last verified: 2008-08

Locations

BR (1)