NCT03611088

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

Status unknown NA Last updated 14 August 2018

What this trial tests

NA trial testing Kangaroo Position. in Kangaroo Mother Care Method in 50 participants. Status unknown.

Timeline

16 July 2018

Primary endpoint
1 September 2018

31 October 2018

Quick facts

Lead sponsor	Professor Fernando Figueira Integral Medicine Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	50
Start date	16 July 2018
Primary completion	1 September 2018
Estimated completion	31 October 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Kangaroo Position.

Conditions studied

• Kangaroo Mother Care Method — all drugs for Kangaroo Mother Care Method →

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Who can join

Adults 27 Weeks to 37 Weeks, any sex, with Kangaroo Mother Care Method. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Kangaroo Position on microcirculation of preterm newborns: a controlled randomized clinical trial.
   Miranda RM, Cabral Filho JE, Diniz KT, Clough GF, et al · · 2022 · cited 3× · PMID 34454941 · DOI 10.1016/j.jped.2021.05.012