Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm

NCT02849665 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-08-16

No results posted yet for this study

Summary

Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight newborn. The Kangaroo Position is the main feature of this method. The infant should be lightly dressed, in prone position and upright against the torax of the parents. Researches provides evidence that the Kangaroo Position induces an increase in myoelectric activity of preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo Position so that ocurr changes in electromyographic. An increase in electromyographic activity was observed after 24 hours or more of submission to the Position Kangaroo, however period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown are the physiological mechanisms that cause this muscle response. One hypothesis would be the increase in temperature caused by skin to skin contact which could improve circulation in small vessels with direct influence on the infusion and nutrition of muscle tissue. Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic activity and microcirculation of preterm newborn. Method: It will be a randomized and controlled trial from August 2016 to February 2017 with newborn preterm admitted at the Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group (control group). The data of the electromyographic activity and the microcirculatory parameters will be assessed and recorded in three stages: before the Kangaroo position, one and three hours after of continuous submission in the Kangaroo Position (for the group of cases) and before the Kangaroo position, one and four after the three assessments (for the control group). In the control group, the preterm newborns will be not submitted to Kangaroo position until the completion of the last and third evaluation. The acquisition of the electromyographic signal will be conducted through an equipment electromyography Miotool 400® brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201). This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento Científico e Tecnológico- CNPq (process 458163/2014-7).

Conditions

  • Child Development

Interventions

OTHER

Kangaroo Position

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • José E. Cabral Filho, PhD · Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

  • Rafael M. Miranda, PhD student · Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

  • João G. Bezerra alves, PhD · Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

  • Geraldine F. Clough, PhD · University of Southampton - Academic Unit of Human Development and Health

  • Kaísa T. Diniz, PhD student · Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
27 Weeks
Max Age
35 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-01
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • Brazil

Study Locations

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Read the full study record

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View NCT02849665 on ClinicalTrials.gov