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Status unknownNCT02166645Updated Jun 18, 2014

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

An interventional study of Prone position and Supine position in Pregnancy Preterm, sponsored by Uniao Metropolitana de Educacao e Cultura. Status unknown at 1 site in Brazil. Open to participants aged Up to 36 Weeks. Per ClinicalTrials.gov, last updated 2014-06-18.

Sponsored by Uniao Metropolitana de Educacao e Cultura · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
Up to 36 Weeks
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pregnancy Preterm

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Keywords

  • patient positioning
  • premature infant
  • mechanical ventilation
  • airway extubation
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In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's planned enrollment of 94 is above the median of 84 across 1,688 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

This is the only study on the registry with Uniao Metropolitana de Educacao e Cultura as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 36 Weeks
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
94 participants (estimated)

Study arms

  • Experimental
    Prone position

    Prone position per 48 hours after extubation

    Other: Prone position

  • Active comparator
    Supine position

    Supine position per 48 hours after extubation

    Other: Supine position

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.

    Also known as: Ventral decubitus

  • 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.

    Also known as: Dorsal decubitus

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What researchers measure

Primary outcomes

  1. Successful extubation

    Time frame: 48 hours after extubation

Secondary outcomes

  1. Improvement of parameters

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

    Time frame: 48 hours after extubation

Other outcomes

  1. Decrease complications of mechanical ventilation

    Time frame: 48 hours after extubation

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Study locations

1 of 1 sites recruiting
  • Manoel Novaes Hospital
    Itabuna, Bahia 45603-305, Brazil
    Recruiting
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References and documents

Publications

  • 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. PubMed 14506534 ↗
  • 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. PubMed 16818554 ↗
  • 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. PubMed 21392826 ↗
  • 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. PubMed 19830358 ↗
  • 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. doi: 10.1164/rccm.200501-004OC. Epub 2005 May 18. PubMed 15901611 ↗
  • 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. PubMed 20130832 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02166645
Lead sponsor
Uniao Metropolitana de Educacao e Cultura
Responsible party
Maria Luiza Caires Comper (Master, Uniao Metropolitana de Educacao e Cultura) — Principal investigator
First posted
Jun 18, 2014
Start date
Mar 2014
Primary completion
Feb 2015 (estimated)
Completion
Feb 2015 (estimated)
Last update
Jun 18, 2014

Study contacts

Maria Luiza Caíres Comper, Master
principal investigator · Uniao Metropolitana de Educacao e Cultura

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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