Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns

Growing evidences indicates that the Kangaroo Mother Method is associated with health benefits for the child and her mother. Improvements have been found in physiological parameters of the preterm infants assisted by the method. Some of them are the reduction of the heart rate and respiratory, as well as the increase of the body temperature and of the arterial saturation of oxygen. More recently, it has been observed that children submitted to the method present an improvement in muscle tone, by the increase in the electromyographic activity of the biceps brachii and hamstrings. These physiological changes can result in benefits for the child, with a positive influence on their development.

It is well established that the preterm newborn has an important circulatory vulnerability, since the transition from fetal life to extrauterine life is a complex process in which the major changes are concentrated in the cardiovascular system and occur during the first Hours after birth accompanied by important consequences in physiological parameters, such as systemic vascular resistance, heart rate and blood flow in the organs. Therefore, global hemodynamic parameters have been studied in premature infants, especially after some intervention. It is worth noting, however, that these global parameters such as blood pressure, heart rate and arterial oxygen saturation do not reflect the existence of adequate tissue oxygenation, since they are macrocirculatory and non-microcirculatory parameters. In order to obtain reliable signals on tissue oxygenation, it is essential to study the microcirculation.

To further explore the effects that Kangaroo Position promotes on the physiological aspects of the newborn, especially on hemodynamic parameters, we consider it important to study aspects that may, in fact, represent an adequate tissue oxygenation. Therefore, the objective of this study is to evaluate the effect of Kangaroo Position in the electromyographic activity and on hemodynamic parameters, by means of microcirculation/macrocirculation measurements.

Study Overview

• Status: Unknown
• Conditions: Kangaroo Mother Care Method
• Intervention / Treatment: Other: Kangaroo Position.

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

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Recife, Pernambuco, Brazil, 51110380
      • Rafael Moura Miranda

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:

• Preterm newborns with gestational ages older or equal than 27 and less than 37 completed weeks of gestation (Ballard Method)
• Preterm newborns hospitalized at Instituto de Medicina Integral Prof. Fernando Figueira (IMIP) with a corrected age less than 37 weeks at the moment of the evaluation
• Preterm newborns who were not submitted to the Kangaroo Position previously.

Exclusion Criteria:

• Apgar less than 7 in the 5''
• Previous history of intracranial hemorrhage (diagnosed by ultrasonography and recorded in the medical record)
• Previous convulsion history
• Congenital infection
• Infections of the central nervous system (meningitis or encephalitis)
• Malformations in the central nervous system
• Congenital cardiopaths
• Trauma during delivery
• Gastroesophageal reflux disease
• Phototherapy and anemia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Newborns submitted to Kangaroo Position.	Other: Kangaroo Position.; The kangaroo position - the newborn is positioned in the adult's breasts, face down, should be dressed in light clothes and wrapped in a flexible cloth.
NO_INTERVENTION: Newborns not submitted to Kangaroo Position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyographic activity	Represented by the recording of the myoelectric signal captured through the electromyographic analysis, analyzed in Root Mean Square (RMS) and measured in microvolts.	1 minute
oxygen artery saturation	Represented by the macrocirculation variables	1 minute
heart rate	Represented by the macrocirculation variables	1 minute
tissue oxygen saturation	Represented by the microcirculation variables	1 minute
oxygenated hemoglobin concentration	Represented by the microcirculation variables	1 minute
deoxygenated hemoglobin concentration	Represented by the microcirculation variables	1 minute
tissue temperature	Represented by the microcirculation variables	1 minute
oxygen flow	Represented by the microcirculation variables	1 minute

Collaborators and Investigators

• Sponsor: Professor Fernando Figueira Integral Medicine Institute
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Publications and helpful links

General Publications

• Miranda RM, Cabral Filho JE, Diniz KT, Clough GF, Alves JGB, Lima GMS, Figueredo NPDS, Franca AA, Luna JTB. Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial. J Pediatr (Rio J). 2022 Mar-Apr;98(2):196-203. doi: 10.1016/j.jped.2021.05.012. Epub 2021 Aug 26.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 16, 2018
• Primary Completion (ANTICIPATED): September 1, 2018
• Study Completion (ANTICIPATED): October 31, 2018

Study Registration Dates

• First Submitted: July 16, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (ACTUAL): August 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 14, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Child Development; Electromyography; Premature; Microcirculation; Kangaroo Mother Care Method
• Other Study ID Numbers: 69847917.7.0000.5201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No