Rebalancing Thoraco Abdominal Heart Disease in Infants (RTAC)

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.

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Key information

Conditions

Infants With Heart Disease Respiratory Therapy Techniques

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joana de Gusmão Children's Hospital

Florianópolis, Santa Catarina, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thoracoabdominal rebalancing

Procedure

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 outcomes

Changes in cardiorespiratory parameters

Time frame: 15 minutes after the end of the intervention
Pain Scales (NIPS, PIPP, NFCS)

Time frame: Immediately after intervention and 15 minutes after the end of the intervention

Sponsors and collaborators

Lead sponsor

University of the State of Santa Catarina

Other

Registry information

Official study title

Evaluation of the Effects of Physical Therapy Method of Restoring Cardiac Thoracic Abdominal Infants

Acronym: RTAC

Important dates

Study start: 2010
Primary completion: 2011
First posted: Dec 7, 2010
Registry last updated: Jun 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed