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

Pregnancy Preterm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02166645
• Other study ID #: NCT
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2014
• Last updated: June 14, 2014
• Start date: March 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2014
• Source: Uniao Metropolitana de Educacao e Cultura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 36 Weeks

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy Preterm
• Premature Birth

Intervention

Other:
• Prone 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.
• Supine 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.

Locations

Country	Name	City	State
Brazil	Manoel Novaes Hospital	Itabuna	Bahia

Sponsors (1)

Lead Sponsor	Collaborator
Uniao Metropolitana de Educacao e Cultura

Country where clinical trial is conducted

Brazil, 

References & 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. — View 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. — View 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. — View Citation

Oliveira TG, Rego MA, Pereira NC, Vaz LO, França 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. — View Citation

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

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. Epub 2005 May 18. — View Citation

Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guérin 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decrease complications of mechanical ventilation		48 hours after extubation	No
Primary	Successful extubation		48 hours after extubation	No
Secondary	Improvement of parameters	Improvement of parameters (respiratory rate, heart rate, saturation of peripheral oxygen, fraction of inspired oxygen and temperature)	48 hours after extubation	No