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

NCT ID: NCT00797160

Last Updated: 2008-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Respiratory Distress Syndrome

Keywords

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propofol midazolam neonate tracheal intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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propofol

2mg/Kg IV in bolus before tracheal intubation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Minutes

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Federal University of Minas Gerais

Principal Investigators

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Yerkes P Silva, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Department of Neonatology of Julia Kubitschek Hospital

Belo Horizonte, Minas Gerais, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Yerkes P Silva, PhD

Role: CONTACT

Phone: 00553199933384

Email: [email protected]

Márcia G Penido, MD

Role: CONTACT

Phone: 00553193047238

Email: [email protected]

Facility Contacts

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Márcia G Penido, MD

Role: primary

References

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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.

Reference Type BACKGROUND

Other Identifiers

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0011.0.287.000-08

Identifier Type: -

Identifier Source: org_study_id