Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)

Not Applicable

Completed

• Conditions: Infants With Heart Disease; Respiratory Therapy; Techniques
• Interventions: Procedure: Thoracoabdominal rebalancing

• Registration Number: NCT01255176
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Status Verified: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-12
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thoracoabdominal rebalancing	Thoracoabdominal rebalancing	infants who receive physical therapy through the application of the handlings of the RTA.

Primary Outcome Measures

Name	Time	Method
Changes in cardiorespiratory parameters	15 minutes after the end of the intervention
Pain Scales (NIPS, PIPP, NFCS)	Immediately after intervention and 15 minutes after the end of the intervention

Trial Locations

Locations (1)

Joana de Gusmão Children's Hospital; 🇧🇷 Florianópolis, Santa Catarina, Brazil