Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by University of the State of Santa Catarina.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of the State of Santa Catarina
Collaborators:
Joana de Gusmão Children's Hospital
Carmela Dutra Maternity
Information provided by:
University of the State of Santa Catarina
ClinicalTrials.gov Identifier:
NCT01255176
First received: December 6, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2010 |
| Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255176
Contacts
| Contact: Joana de Gusmão Children's Hospital | 55 (48)32519000 |
Locations
| Brazil | |
| Joana de Gusmão Children's Hospital | Recruiting |
| Florianópolis, Santa Catarina, Brazil | |
| Principal Investigator: Camila Schivinski, Doctor | |
Sponsors and Collaborators
University of the State of Santa Catarina
Joana de Gusmão Children's Hospital
Carmela Dutra Maternity
Investigators
| Principal Investigator: | Camila Schivinski, Doctor | Professor of Universidade do Estado de Santa Catarina |
More Information
No publications provided
| Responsible Party: | Camila Isabel S. Schivinski, Professor of Universidade do Estado de Santa Catarina |
| ClinicalTrials.gov Identifier: | NCT01255176 History of Changes |
| Other Study ID Numbers: | AEMFRTALC2010 |
| Study First Received: | December 6, 2010 |
| Last Updated: | December 6, 2010 |
| 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 May 23, 2013