Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC) (RTAC)
Primary Purpose
Infants With Heart Disease, Respiratory Therapy, Techniques
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Thoracoabdominal rebalancing
Sponsored by

About this trial
This is an interventional treatment trial for Infants With Heart Disease focused on measuring Infant, Physical Therapy
Eligibility 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.
Sites / Locations
- Joana de Gusmão Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
No Intervention
Experimental
Arm Label
placebo group
control group
Thoracoabdominal rebalancing
Arm Description
not receive physical therapy intervention, there will only support the achievement of a handbook on the abdomen of the baby.
not receive any type of intervention, and infants remain at rest
infants who receive physical therapy through the application of the handlings of the RTA.
Outcomes
Primary Outcome Measures
Changes in cardiorespiratory parameters
Pain Scales (NIPS, PIPP, NFCS)
Secondary Outcome Measures
Full Information
NCT ID
NCT01255176
First Posted
December 6, 2010
Last Updated
June 18, 2013
Sponsor
University of the State of Santa Catarina
1. Study Identification
Unique Protocol Identification Number
NCT01255176
Brief Title
Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)
Acronym
RTAC
Official Title
Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the State of Santa Catarina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infants With Heart Disease, Respiratory Therapy, Techniques
Keywords
Infant, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo group
Arm Type
No Intervention
Arm Description
not receive physical therapy intervention, there will only support the achievement of a handbook on the abdomen of the baby.
Arm Title
control group
Arm Type
No Intervention
Arm Description
not receive any type of intervention, and infants remain at rest
Arm Title
Thoracoabdominal rebalancing
Arm Type
Experimental
Arm Description
infants who receive physical therapy through the application of the handlings of the RTA.
Intervention Type
Procedure
Intervention Name(s)
Thoracoabdominal rebalancing
Intervention Description
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 Measure Information:
Title
Changes in cardiorespiratory parameters
Time Frame
15 minutes after the end of the intervention
Title
Pain Scales (NIPS, PIPP, NFCS)
Time Frame
Immediately after intervention and 15 minutes after the end of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camila Schivinski, Doctor
Organizational Affiliation
Professor of Universidade do Estado de Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joana de Gusmão Children's Hospital
City
Florianópolis
State/Province
Santa Catarina
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)
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