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

August 12, 2017 updated by: Kaísa Trovão Diniz, Professor Fernando Figueira Integral Medicine Institute

Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.

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).

Study Overview

Status

Status

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Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Recruiting
        • Unidade Canguru
        • Contact:

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

6 months to 8 months (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Kangaroo Position
No Intervention: Not Kangaroo Position
The newborns will be not placed in the position Kangaroo.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Electromyographic activity
Time Frame: 15 minutes
Measure of the changes in electric potential of muscle.
15 minutes
Tissue oxygen saturation - SO2
Time Frame: 5 minutes
5 minutes
Relative oxygenated haemoglobin concentration - oxyHb
Time Frame: 5 minutes
5 minutes
Relative deoxygenated haemoglobin concentration - deoxyHb
Time Frame: 5 minutes
5 minutes
Relative total haemoglobin concentration -totalHb
Time Frame: 5 minutes
5 minutes
Temperature
Time Frame: 5 minutes
Tissue temperature
5 minutes
Blood flow
Time Frame: 5 minutes
A quantity proportional to the product of the average speed of the blood cells and their number concentration.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Professor Fernando Figueira Integral Medicine Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: José E. Cabral Filho, PhD, Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
  • Study Chair: Rafael M. Miranda, PhD student, Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
  • Study Chair: João G. Bezerra alves, PhD, Instituto De Medicina Integral Prof. Fernando Figueira - IMIP
  • Study Chair: Geraldine F. Clough, PhD, University of Southampton - Academic Unit of Human Development and Health
  • Principal Investigator: Kaísa T. Diniz, PhD student, Instituto De Medicina Integral Prof. Fernando Figueira - IMIP

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 458163/2014-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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