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Clinical Trials/NCT02166645
NCT02166645
Unknown
Not Applicable

Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol

Uniao Metropolitana de Educacao e Cultura1 site in 1 country94 target enrollmentMarch 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Preterm
Sponsor
Uniao Metropolitana de Educacao e Cultura
Enrollment
94
Locations
1
Primary Endpoint
Successful extubation
Last Updated
11 years ago

Overview

Brief Summary

The purpose of this study is to determine whether patient positioning (prone and supine positioning) contributes to the success of extubation in the immediate postextubation period of preterm infants.

Detailed Description

This study is double-blinded randomized controlled trial, whose aim is to compare the proportion of successful extubation of preterm infants immediately after the extubation. Methods: Participants will be recruited from neonatal intensive care unit (NICU) and they will be divided into two groups (supine and prone) and positioned in their respective groups after extubation. A clinical evaluation form and a parameters collection form (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature) will be used and filled before extubation and 48 hours after by the professional staff of the NICU. It will be considered a successful extubation all participants who staying extubated for 48 hours after extubation.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
February 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uniao Metropolitana de Educacao e Cultura
Responsible Party
Principal Investigator
Principal Investigator

Maria Luiza Caires Comper

Master

Uniao Metropolitana de Educacao e Cultura

Eligibility Criteria

Inclusion Criteria

  • Newborns less than 37 weeks of gestation age (calculated by doctor using the method of Capurro/Ballard)
  • Newborns undergone to invasive mechanical ventilation in the first week of life, for more than 48 hours

Exclusion Criteria

  • Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation

Outcomes

Primary Outcomes

Successful extubation

Time Frame: 48 hours after extubation

Secondary Outcomes

  • Improvement of parameters(48 hours after extubation)

Study Sites (1)

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