Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Introdution: The Kangaroo Mother Care is a perinatal care model for preterm and low weight newborn. The Kangaroo Position is the main feature of this method. The infant should be lightly dressed, in prone position and upright against the torax of the parents. Researches provides evidence that the Kangaroo Position induces an increase in myoelectric activity of preterm newborn. However, it is unknown how long the newborn should remain in the kangaroo Position so that ocurr changes in electromyographic. An increase in electromyographic activity was observed after 24 hours or more of submission to the Position Kangaroo, however period lower of submission to the Position Kangaroo have not been evaluated yet. Also unknown are the physiological mechanisms that cause this muscle response. One hypothesis would be the increase in temperature caused by skin to skin contact which could improve circulation in small vessels with direct influence on the infusion and nutrition of muscle tissue. Objective: Evaluate the immediate effect of Kangaroo position in the electromyographic activity and microcirculation of preterm newborn. Method: It will be a randomized and controlled trial from August 2016 to February 2017 with newborn preterm admitted at the Kangaroo Unit, IMIP. Newborns eligible according to the inclusion and exclusion criteria will be randomized into two groups: Kangaroo Group (experimental group) and Not Kangaroo Group (control group). The data of the electromyographic activity and the microcirculatory parameters will be assessed and recorded in three stages: before the Kangaroo position, one and three hours after of continuous submission in the Kangaroo Position (for the group of cases) and before the Kangaroo position, one and four after the three assessments (for the control group). In the control group, the preterm newborns will be not submitted to Kangaroo position until the completion of the last and third evaluation. The acquisition of the electromyographic signal will be conducted through an equipment electromyography Miotool 400® brand (Miotec Equipamentos Biomédicos - Brasil). To assess microcirculation will be used for the white light spectroscopy method through the drive moorVMS-OXY®. The project was submitted and approved by Ethics Committee for Research on Human Beings of IMIP (52381915.5.0000.5201). This study is part of a anchor project approved by Conselho Nacional de Desenvolvimento Científico e Tecnológico- CNPq (process 458163/2014-7).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03611088

Kangaroo Mother Care Method

UNKNOWN NA

Electromyographic Activity of Preterm Newborns Submitted to Hammock Positioning

NCT02668107

Infant, Premature, Diseases

UNKNOWN NA

Kangaroo Position in Preterm Newborn Infants Under Oxygen Therapy

NCT06170892

Newborn Morbidity

RECRUITING NA

Comparison Between Preterm Infants Who Are Placed on Their Back or Stomach in the Immediate Postextubation Period

NCT02166645

Pregnancy Preterm

UNKNOWN NA

Kangaroo Care and Premature Infant Sleep

NCT02473055

Premature Birth of Newborn

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Child Development

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Kangaroo Position

The newborn remains in a vertical position, with limbs flexed, dressed in light clothes, maintaining skin-to-skin contact and the face on the adult's thorax.

Group Type EXPERIMENTAL

Kangaroo Position

Intervention Type OTHER

Not Kangaroo Position

The newborns will be not placed in the position Kangaroo.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Kangaroo Position

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* a gestational age of 27-34 weeks;
* corrected age of until 35 weeks at the time of the first examination;
* had not previously been in the kangaroo position;

Exclusion Criteria

* Apgar lower than 7 in the 5th min;
* a history of grade III or IV intracranial haemorrhage (diagnosed by way of transfontanelar ultrasound and included in the medical records);
* seizures;
* congenital infections (cytomegalovirus, rubella, toxoplasmosis, syphilis and vertically transmitted HIV)
* malformations of the central nervous system (hydrocephaly and genetic syndromes), infections of the central nervous system (meningitis or encephalitis);
* congenital cardiopathy;
* traumas during delivery (injuries to the brachial plexus, dislocation of the hip and pelvis fractures) and gastro-oesophageal reflux disorder.

Minimum Eligible Age

27 Weeks

Maximum Eligible Age

35 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kaísa Trovão Diniz

It is PhD student in Mother and Child Health for Instituto de Medicina Integral Prof. Fernando Figueira (IMIP- Brazil ), where he earned a master's degree in the same area in 2012. Is currently Physiotherapist at IMIP.

Responsibility Role PRINCIPAL_INVESTIGATOR