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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02166645
Enrollment
94
Registered
2014-06-18
Start date
2014-03-31
Completion date
2015-02-28
Last updated
2014-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy Preterm

Keywords

patient positioning, premature infant, mechanical ventilation, airway extubation

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.

Interventions

OTHERProne 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.

OTHERSupine 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.

Sponsors

Uniao Metropolitana de Educacao e Cultura
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 36 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Successful extubation48 hours after extubation

Secondary

MeasureTime frameDescription
Improvement of parameters48 hours after extubationImprovement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)

Other

MeasureTime frame
Decrease complications of mechanical ventilation48 hours after extubation

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026