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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Preterm

Intervention / Treatment
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* Other: Prone position
* Other: Supine position


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prone position<br>Prone position per 48 hours after extubation | Other: Prone position<br>* 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.<br>* Other names: Ventral decubitus;|
| Active Comparator: Supine position<br>Supine position per 48 hours after extubation | Other: Supine position<br>* 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.<br>* Other names: Dorsal decubitus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful extubation |  | 48 hours after extubation | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient positioning, premature infant, mechanical ventilation, airway extubation