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

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ClinicalTrials.gov Identifier: NCT02849665
Recruitment Status : Unknown
Verified August 2017 by Kaísa Trovão Diniz, Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was:  Recruiting
First Posted : July 29, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Kaísa Trovão Diniz, Professor Fernando Figueira Integral Medicine Institute

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Child Development Other: Kangaroo Position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Immediate Effect of Kangaroo Position in Electromyographic Activity and Microcirculation of Newborn Preterm: A Randomized Clinical Trial.
Study Start Date : October 1, 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Electromyographic activity [ Time Frame: 15 minutes ]
    Measure of the changes in electric potential of muscle.

  2. Tissue oxygen saturation - SO2 [ Time Frame: 5 minutes ]
  3. Relative oxygenated haemoglobin concentration - oxyHb [ Time Frame: 5 minutes ]
  4. Relative deoxygenated haemoglobin concentration - deoxyHb [ Time Frame: 5 minutes ]
  5. Relative total haemoglobin concentration -totalHb [ Time Frame: 5 minutes ]
  6. Temperature [ Time Frame: 5 minutes ]
    Tissue temperature

  7. Blood flow [ Time Frame: 5 minutes ]
    A quantity proportional to the product of the average speed of the blood cells and their number concentration.



Information from the National Library of Medicine

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Ages Eligible for Study:   27 Weeks to 35 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02849665


Contacts
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Contact: Kaísa T. Diniz, PhD student +55 81 999328432 kaisa.tdz@hotmail.com
Contact: José E. Cabral Filho, PhD + 55 81 22122 4122 eulalio@imip.org.br

Locations
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Brazil
Unidade Canguru Recruiting
Recife, Pernambuco, Brazil, 50070-550
Contact: Geisy Maria Souza Lima, MD    55 81 21224125    canguru@imip.org.br   
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: 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., Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT02849665    
Other Study ID Numbers: 458163/2014-7
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kaísa Trovão Diniz, Professor Fernando Figueira Integral Medicine Institute:
Kangaroo-Mother Care Method; child development