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

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

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).

Study Overview

• Status: Unknown
• Conditions: Child Development
• Intervention / Treatment: Other: Kangaroo Position

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kaísa T. Diniz, PhD student; Phone Number: +55 81 999328432; Email: kaisa.tdz@hotmail.com
• Study Contact Backup: Name: José E. Cabral Filho, PhD; Phone Number: + 55 81 22122 4122; Email: eulalio@imip.org.br

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 50070-550
      • Recruiting
      • Unidade Canguru
      • Contact: Geisy Maria Souza Lima, MD; Phone Number: 55 81 21224125; Email: canguru@imip.org.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kangaroo Position; 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
No Intervention: Not Kangaroo Position; 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

Collaborators and Investigators

• Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Investigators: Study Director: José E. Cabral Filho, PhD, Instituto de Medicina Integral Prof. Fernando Figueira - Imip; Study Chair: Rafael M. Miranda, PhD student, Instituto de Medicina Integral Prof. Fernando Figueira - Imip; Study Chair: João G. Bezerra alves, PhD, Instituto de Medicina Integral Prof. Fernando Figueira - Imip; Study Chair: Geraldine F. Clough, PhD, University of Southampton - Academic Unit of Human Development and Health; Principal Investigator: Kaísa T. Diniz, PhD student, Instituto de Medicina Integral Prof. Fernando Figueira - Imip

Publications and helpful links

General Publications

• Diniz KT, Cabral Filho JE, Miranda RM, Lima GMS, Figueredo NPDS, Araujo KFN. Short-time effect of the kangaroo position on electromyographic activity of premature infants: a randomized clinical trial. J Pediatr (Rio J). 2020 Nov-Dec;96(6):741-747. doi: 10.1016/j.jped.2019.10.003. Epub 2019 Oct 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): August 1, 2017

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 16, 2017
• Last Update Submitted That Met QC Criteria: August 12, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Kangaroo-Mother Care Method; child development
• Other Study ID Numbers: 458163/2014-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED