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

Kangaroo Mother Care Method Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03611088
• Other study ID #: 69847917.7.0000.5201
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: August 2018
• Source: Professor Fernando Figueira Integral Medicine Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: October 31, 2018
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 27 Weeks to 37 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Kangaroo Mother Care Method

Intervention

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.

Locations

Country	Name	City	State
Brazil	Rafael Moura Miranda	Recife	Pernambuco

Sponsors (2)

Lead Sponsor	Collaborator
Professor Fernando Figueira Integral Medicine Institute	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	oxygen artery saturation	Represented by the macrocirculation variables	1 minute
Primary	heart rate	Represented by the macrocirculation variables	1 minute
Primary	tissue oxygen saturation	Represented by the microcirculation variables	1 minute
Primary	oxygenated hemoglobin concentration	Represented by the microcirculation variables	1 minute
Primary	deoxygenated hemoglobin concentration	Represented by the microcirculation variables	1 minute
Primary	tissue temperature	Represented by the microcirculation variables	1 minute
Primary	oxygen flow	Represented by the microcirculation variables	1 minute