Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Camila Isabel Santos Schivinski, University of the State of Santa Catarina
ClinicalTrials.gov Identifier:
NCT01255176
First received: December 6, 2010
Last updated: June 18, 2013
Last verified: December 2010
  Purpose

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 Intervention
Infants With Heart Disease
Respiratory Therapy
Techniques
Procedure: Thoracoabdominal rebalancing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants

Resource links provided by NLM:


Further study details as provided by University of the State of Santa Catarina:

Primary Outcome Measures:
  • Changes in cardiorespiratory parameters [ Time Frame: 15 minutes after the end of the intervention ] [ Designated as safety issue: No ]
  • Pain Scales (NIPS, PIPP, NFCS) [ Time Frame: Immediately after intervention and 15 minutes after the end of the intervention ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255176

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

No publications provided

Responsible Party: Camila Isabel Santos Schivinski, Dr., University of the State of Santa Catarina
ClinicalTrials.gov Identifier: NCT01255176     History of Changes
Other Study ID Numbers: AEMFRTALC2010
Study First Received: December 6, 2010
Last Updated: June 18, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of the State of Santa Catarina:
Infant
Physical Therapy

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014