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

Study Overview
=================
Brief 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).

Official Title
-----------------
Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.

Conditions
-----------------
Child Development

Intervention / Treatment
-----------------
* Other: Kangaroo Position


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a gestational age of 27-34 weeks; corrected age of until 35 weeks at the time of the first examination; had not previously been in the kangaroo position; Exclusion Criteria: Apgar lower than 7 in the 5th min; a history of grade III or IV intracranial haemorrhage (diagnosed by way of transfontanelar ultrasound and included in the medical records); seizures; congenital infections (cytomegalovirus, rubella, toxoplasmosis, syphilis and vertically transmitted HIV) malformations of the central nervous system (hydrocephaly and genetic syndromes), infections of the central nervous system (meningitis or encephalitis); congenital cardiopathy; traumas during delivery (injuries to the brachial plexus, dislocation of the hip and pelvis fractures) and gastro-oesophageal reflux disorder.

Ages Eligible for Study
-----------------
Minimum Age: 27 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangaroo Position<br>The newborn remains in a vertical position, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact and the face on the adult's thorax. | Other: Kangaroo Position<br> <br> |
| No Intervention: Not Kangaroo Position<br>The newborns will be not placed in the position Kangaroo. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electromyographic activity | Measure of the changes in electric potential of muscle. | 15 minutes | 
| Tissue oxygen saturation - SO2 |  | 5 minutes | 
| Relative oxygenated haemoglobin concentration - oxyHb |  | 5 minutes | 
| Relative deoxygenated haemoglobin concentration - deoxyHb |  | 5 minutes | 
| Relative total haemoglobin concentration -totalHb |  | 5 minutes | 
| Temperature | Tissue temperature | 5 minutes | 
| Blood flow | A quantity proportional to the product of the average speed of the blood cells and their number concentration. | 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kangaroo-Mother Care Method; child development