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

NCT02849665 | Unknown

• 1 other identifier: 458163/2014-7
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Child Development

Keywords

Kangaroo-Mother Care Method; child development

Outcome Measures

Primary Outcomes (7)

• 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

Study Arms (2)

Kangaroo Position

EXPERIMENTAL

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

Not Kangaroo Position

NO INTERVENTION

The newborns will be not placed in the position Kangaroo.

Interventions

Kangaroo Position OTHER

Kangaroo Position

Eligibility Criteria

• Age: 27 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Professor Fernando Figueira Integral Medicine Institute: lead

Study Sites (1)

Unidade Canguru

Recife, Pernambuco, 50070-550, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 31622569 DERIVED

Study Officials

• José E. Cabral Filho, PhD

  Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• Kaísa T. Diniz, PhD student

  Instituto de Medicina Integral Prof. Fernando Figueira - IMIP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaísa T. Diniz, PhD student

CONTACT

+55 81 999328432; kaisa.tdz@hotmail.com

José E. Cabral Filho, PhD

CONTACT

+ 55 81 22122 4122; eulalio@imip.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: It is PhD student in Mother and Child Health for Instituto de Medicina Integral Prof. Fernando Figueira (IMIP- Brazil ), where he earned a master's degree in the same area in 2012. Is currently Physiotherapist at IMIP.

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 29, 2016
• Study Start: October 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

BR (1)