Clinical trial NCT03611088: Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns
Official title: Effect of Kangaroo Position on Electromyographic Activity, Macrocirculation and Microcirculation of Preterm Newborns
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kangaroo Mother Care Method
Keywords: Child Development
Kangaroo Mother Care Method
Electromyography
Microcirculation
Premature
Lead sponsor: Professor Fernando Figueira Integral Medicine Institute
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2018-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 27
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Electromyographic activity
timeFrame: 1 minute
measure: oxygen artery saturation
timeFrame: 1 minute
measure: heart rate
timeFrame: 1 minute
measure: tissue oxygen saturation
timeFrame: 1 minute
measure: oxygenated hemoglobin concentration
timeFrame: 1 minute
measure: deoxygenated hemoglobin concentration
timeFrame: 1 minute
measure: tissue temperature
timeFrame: 1 minute
measure: oxygen flow
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Rafael Moura Miranda
state: Pernambuco
Study officials:
References:
citation: 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.