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

Primary Purpose

Pregnancy Preterm

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Prone position
Supine position
Sponsored by
Uniao Metropolitana de Educacao e Cultura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy Preterm focused on measuring patient positioning, premature infant, mechanical ventilation, airway extubation

Eligibility Criteria

undefined - 36 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • Manoel Novaes HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prone position

Supine position

Arm Description

Prone position per 48 hours after extubation

Supine position per 48 hours after extubation

Outcomes

Primary Outcome Measures

Successful extubation

Secondary Outcome Measures

Improvement of parameters
Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)

Full Information

First Posted
June 14, 2014
Last Updated
June 14, 2014
Sponsor
Uniao Metropolitana de Educacao e Cultura
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1. Study Identification

Unique Protocol Identification Number
NCT02166645
Brief Title
Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period
Official Title
Comparison of Prone and Supine Positioning in the Immediate Postextubation Period of Preterm Infants: a Randomized Controlled Trial Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uniao Metropolitana de Educacao e Cultura

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Preterm
Keywords
patient positioning, premature infant, mechanical ventilation, airway extubation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prone position
Arm Type
Experimental
Arm Description
Prone position per 48 hours after extubation
Arm Title
Supine position
Arm Type
Active Comparator
Arm Description
Supine position per 48 hours after extubation
Intervention Type
Other
Intervention Name(s)
Prone position
Other Intervention Name(s)
Ventral decubitus
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Supine position
Other Intervention Name(s)
Dorsal decubitus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Successful extubation
Time Frame
48 hours after extubation
Secondary Outcome Measure Information:
Title
Improvement of parameters
Description
Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)
Time Frame
48 hours after extubation
Other Pre-specified Outcome Measures:
Title
Decrease complications of mechanical ventilation
Time Frame
48 hours after extubation

10. Eligibility

Sex
All
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luiza Caíres Comper, Master
Organizational Affiliation
Uniao Metropolitana de Educacao e Cultura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manoel Novaes Hospital
City
Itabuna
State/Province
Bahia
ZIP/Postal Code
45603-305
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Klênia Corrêa Solis Carrazza
Phone
55 73 3214-4300
Email
kcscarrazza@yahoo.com.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
14506534
Citation
Antunes LC, Rugolo LM, Crocci AJ. [Effect of preterm infant position on weaning from mechanical ventilation]. J Pediatr (Rio J). 2003 May-Jun;79(3):239-44. Portuguese.
Results Reference
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PubMed Identifier
16818554
Citation
Bhat RY, Hannam S, Pressler R, Rafferty GF, Peacock JL, Greenough A. Effect of prone and supine position on sleep, apneas, and arousal in preterm infants. Pediatrics. 2006 Jul;118(1):101-7. doi: 10.1542/peds.2005-1873.
Results Reference
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PubMed Identifier
21392826
Citation
Jarus T, Bart O, Rabinovich G, Sadeh A, Bloch L, Dolfin T, Litmanovitz I. Effects of prone and supine positions on sleep state and stress responses in preterm infants. Infant Behav Dev. 2011 Apr;34(2):257-63. doi: 10.1016/j.infbeh.2010.12.014. Epub 2011 Mar 9.
Results Reference
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PubMed Identifier
19830358
Citation
Oliveira TG, Rego MA, Pereira NC, Vaz LO, Franca DC, Vieira DS, Parreira VF. Prone position and reduced thoracoabdominal asynchrony in preterm newborns. J Pediatr (Rio J). 2009 Sep-Oct;85(5):443-8. doi: 10.2223/JPED.1932. English, Portuguese.
Results Reference
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Citation
Paiva KCA, Beppu OS. Posição prona. J Bras Pneumol. 2005;31(4):332-340.
Results Reference
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PubMed Identifier
15901611
Citation
Richter T, Bellani G, Scott Harris R, Vidal Melo MF, Winkler T, Venegas JG, Musch G. Effect of prone position on regional shunt, aeration, and perfusion in experimental acute lung injury. Am J Respir Crit Care Med. 2005 Aug 15;172(4):480-7. doi: 10.1164/rccm.200501-004OC. Epub 2005 May 18.
Results Reference
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PubMed Identifier
20130832
Citation
Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4.
Results Reference
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Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period

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