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

Not Applicable

• Conditions: Pregnancy Preterm
• Interventions: Other: Prone position; Other: Supine position

• Registration Number: NCT02166645
• Lead Sponsor: Uniao Metropolitana de Educacao e Cultura

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.

Study Timeline

• Study Start: 2014-03
• Status Verified: 2014-05
• Study First Submitted: 2014-06-14
• Study First Submitted QC: 2014-06-14
• Last Update Submitted: 2014-06-14
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18
• Primary Completion: 2015-02
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone position	Prone position	Prone position per 48 hours after extubation
Supine position	Supine position	Supine position per 48 hours after extubation

Primary Outcome Measures

Name	Time	Method
Successful extubation	48 hours after extubation

Secondary Outcome Measures

Name	Time	Method
Improvement of parameters	48 hours after extubation	Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)

Trial Locations

Locations (1)

Manoel Novaes Hospital; 🇧🇷 Itabuna, Bahia, Brazil