Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC) (RTAC)

June 18, 2013 updated by: Camila Isabel Santos Schivinski, University of the State of Santa Catarina

Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants

It gave a clinical trial which will be included in the 60 infants, aged up to 24 months, diagnosed with congenital's population will be divided by simple randomization into three groups: 20 infants in the intervention group, 20 infants in the control group, not receive the RTA technique and another 20 infants in a placebo group, we just get the support manual therapist for 5 minutes. Initially the data will be collected cardio heart rate, respiratory rate and oxygen saturation. Then the researcher will apply three specific rating scales, based on clinical presentation and behavior of infants. Hypothesis: The RTA improves cardiorespiratory parameters and reduces signs of discomfort and pain of infants with congenital heart acyanogenic.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil
        • Joana de Gusmão Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Newborns admitted to the nursery without ventilatory support or oxygen therapy, and whose parents agree with the child's participation in the study. Will be excluded newborns who have some problems during any of the study procedures and those whose condition will change after the intervention, with shift in ventilatory support or oxygen therapy.

Exclusion Criteria:

  • In case of inability to collect some of the parameters evaluated at the appropriate time, the RN also will no longer part of the sample, as well as those who show no contraindication to therapy.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: placebo group
not receive physical therapy intervention, there will only support the achievement of a handbook on the abdomen of the baby.
NO_INTERVENTION: control group
not receive any type of intervention, and infants remain at rest
EXPERIMENTAL: Thoracoabdominal rebalancing
infants who receive physical therapy through the application of the handlings of the RTA.
Procedure: Thoracoabdominal rebalancing
In this group the infants received four handlings thoracoabdominal rebalancing, in order: 1) 5min support thoracoabdominal, in which the therapist leaned one hand on the lower chest and upper abdomen of the newborn, with some of its fingers on the ribs, pulling them gently down and keeping them in that position during inspiration, 2) more than 5 minutes of abdominal support, carried by hand in the lower abdomen of the newborn, applying light pressure during inspiration enough to be beaten by the diaphragm of the newborn and not to increase the use of accessory muscles of inspiration, 3) 5min support ileo-costal, by a slight manual pressure of the physiotherapist on the lateral chest and abdomen of the newborn, maintained throughout inspiration and 4) finally ran up 5min ginga thoracic maneuver slight manual pressure on the lower chest of newborns, directing the costal movement during expiration, now an then the other hemithorax.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in cardiorespiratory parameters
Time Frame: 15 minutes after the end of the intervention
15 minutes after the end of the intervention
Pain Scales (NIPS, PIPP, NFCS)
Time Frame: Immediately after intervention and 15 minutes after the end of the intervention
Immediately after intervention and 15 minutes after the end of the intervention

Collaborators and Investigators

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

Sponsor

University of the State of Santa Catarina

Investigators

  • Principal Investigator: Camila Schivinski, Doctor, Professor of Universidade do Estado de Santa Catarina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AEMFRTALC2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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