Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period

June 14, 2014 updated by: Maria Luiza Caires Comper, Uniao Metropolitana de Educacao e Cultura

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Bahia
      • Itabuna, Bahia, Brazil, 45603-305
        • Recruiting
        • Manoel Novaes Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 8 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prone position
Prone position per 48 hours after extubation
Other: Prone position
Participants of intervention group will be placed in prone position immediately after extubation and positioned over a roll to raise the chest and facilitate diaphragmatic dynamic, with lateralized head and aligned with the trunk, upper and lower limbs flexed and hands near the face, facilitating hand-mouth access.
Other Names:
  • Ventral decubitus
Active Comparator: Supine position
Supine position per 48 hours after extubation
Other: Supine position
Participants of control group remain in supine position after extubation and positioned with the head in the midline, with the upper side of the thorax and brought forward and rolls down the legs to promote slight flexion (30-40º) in the hips and knees.
Other Names:
  • Dorsal decubitus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful extubation
Time Frame: 48 hours after extubation
48 hours after extubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of parameters
Time Frame: 48 hours after extubation
Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)
48 hours after extubation

Other Outcome Measures

Outcome Measure
Time Frame
Decrease complications of mechanical ventilation
Time Frame: 48 hours after extubation
48 hours after extubation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uniao Metropolitana de Educacao e Cultura

Investigators

  • Principal Investigator: Maria Luiza Caíres Comper, Master, Uniao Metropolitana de Educacao e Cultura

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

February 1, 2015

Study Completion (Anticipated)

February 1, 2015

Study Registration Dates

First Submitted

June 14, 2014

First Submitted That Met QC Criteria

June 14, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 14, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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