Clinical trial NCT02849665: Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm
Official title: Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Development
Keywords: Kangaroo-Mother Care Method; child development
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
First posted: 2016-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 27
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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).


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.

Primary outcomes:
measure: Electromyographic activity
timeFrame: 15 minutes
measure: Tissue oxygen saturation - SO2
timeFrame: 5 minutes
measure: Relative oxygenated haemoglobin concentration - oxyHb
timeFrame: 5 minutes
measure: Relative deoxygenated haemoglobin concentration - deoxyHb
timeFrame: 5 minutes
measure: Relative total haemoglobin concentration -totalHb
timeFrame: 5 minutes
measure: Temperature
timeFrame: 5 minutes
measure: Blood flow
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Unidade Canguru
state: Pernambuco
Study officials:
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
name: José E. Cabral Filho, PhD
role: STUDY_DIRECTOR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
name: Rafael M. Miranda, PhD student
role: STUDY_CHAIR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
name: João G. Bezerra alves, PhD
role: STUDY_CHAIR
affiliation: University of Southampton - Academic Unit of Human Development and Health
name: Geraldine F. Clough, PhD
role: STUDY_CHAIR
affiliation: Instituto de Medicina Integral Prof. Fernando Figueira - IMIP
name: Kaísa T. Diniz, PhD student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.