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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255176
Recruitment Status : Completed
First Posted : December 7, 2010
Last Update Posted : June 19, 2013
Information provided by (Responsible Party):
Camila Isabel Santos Schivinski, University of the State of Santa Catarina

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infants With Heart Disease Respiratory Therapy Techniques Procedure: Thoracoabdominal rebalancing Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants
Study Start Date : January 2010
Actual Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

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.

Primary Outcome Measures :
  1. Changes in cardiorespiratory parameters [ Time Frame: 15 minutes after the end of the intervention ]
  2. Pain Scales (NIPS, PIPP, NFCS) [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ]

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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01255176

Joana de Gusmão Children's Hospital
Florianópolis, Santa Catarina, Brazil
Sponsors and Collaborators
University of the State of Santa Catarina
Principal Investigator: Camila Schivinski, Doctor Professor of Universidade do Estado de Santa Catarina

Responsible Party: Camila Isabel Santos Schivinski, Dr., University of the State of Santa Catarina Identifier: NCT01255176     History of Changes
Other Study ID Numbers: AEMFRTALC2010
First Posted: December 7, 2010    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: December 2010

Keywords provided by Camila Isabel Santos Schivinski, University of the State of Santa Catarina:
Physical Therapy

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases