Kangaroo Mother Care Method Clinical Trial
Official title:
Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns
Verified date | August 2018 |
Source | Professor Fernando Figueira Integral Medicine Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Rafael Moura Miranda | Recife | Pernambuco |
Lead Sponsor | Collaborator |
---|---|
Professor Fernando Figueira Integral Medicine Institute | Conselho Nacional de Desenvolvimento Científico e Tecnológico |
Brazil,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05491265 -
Impact of Intermittent Kangaroo Mother Care Versus Conventional Care Method on Vital Sign and Arterial Oxygen Saturation in Preterm Hospitalized in Neonatal Intensive Care Unit
|
N/A |