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

Uniao Metropolitana de Educacao e Cultura

Status: Unknown

Conditions: Pregnancy Preterm

Treatments: Other: Supine position; Other: Prone position

Study type: Interventional

Funder types: Other

Identifiers

NCT02166645

NCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 estimated patients

Sex: All

Ages: Under 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Prone position

Experimental group

Description:

Prone position per 48 hours after extubation

Treatment:

Other: Prone position

Supine position

Active Comparator group

Description:

Supine position per 48 hours after extubation

Treatment:

Other: Supine position