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

NCT02166645 | Unknown DMC

• 1 other identifier: NCT
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Preterm

Keywords

patient positioning; premature infant; mechanical ventilation; airway extubation

Outcome Measures

Primary Outcomes (1)

• Successful extubation

  48 hours after extubation

Secondary Outcomes (1)

• Improvement of parameters

  48 hours after extubation

Other Outcomes (1)

• Decrease complications of mechanical ventilation

  48 hours after extubation

Study Arms (2)

Prone position

EXPERIMENTAL

Prone position per 48 hours after extubation

Other: Prone position

Supine position

ACTIVE COMPARATOR

Supine position per 48 hours after extubation

Other: Supine position

Interventions

Prone position OTHER

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.

Also known as: Ventral decubitus

Prone position

Supine position OTHER

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.

Also known as: Dorsal decubitus

Supine position

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Newborns who present malformations and clinical or surgical conditions that preclude the positioning in prone or supine after extubation

Sponsors & Collaborators

• Uniao Metropolitana de Educacao e Cultura: lead

Study Sites (1)

Manoel Novaes Hospital

Itabuna, Estado de Bahia, 45603-305, Brazil

RECRUITING

Related Publications (7)

• 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.

  PMID: 14506534 BACKGROUND

• 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.

  PMID: 16818554 BACKGROUND

• 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.

  PMID: 21392826 BACKGROUND

• 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.

  PMID: 19830358 BACKGROUND

• Paiva KCA, Beppu OS. Posição prona. J Bras Pneumol. 2005;31(4):332-340.

  BACKGROUND

• 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.

  PMID: 15901611 BACKGROUND

• 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.

  PMID: 20130832 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Interventions

Prone Position; Supine Position

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Maria Luiza Caíres Comper, Master

  Uniao Metropolitana de Educacao e Cultura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master

Study Record Dates

• First Submitted: June 14, 2014
• First Posted: June 18, 2014
• Study Start: March 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 18, 2014

Record last verified: 2014-05

Locations

BR (1)