Pain in preterm new born and physiotherapy.
- Conditions
- C10.597.617Preterm,Pain,Pulmonary disease.M01.060.703.520.520
- Registration Number
- RBR-4233sv
- Lead Sponsor
- Fundação Santa Casa de Misericórdia do Pará
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Volunteers with gestational age between 28 and 37 weeks, according to the who criteria; weight less than or equal to 2500 g; they're in use of invasive mechanical ventilation, with diagnosis of Respiratory distress syndrome and with indication for respiratory physiotherapy.
It will be excluded premature newborns with congenital malformations, chromosomal syndromes, intracranial bleeding or clinical neurological changes of any nature; those with chest or abdominal drain; use of sedation above 2 mg/kg; in use of vasoactive drugs.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain quantification during physical therapy treatment, evaluated by the NIPS scales: Neonatal Infant Pain Scale and BIPP: Behavioral Indicators of Infant Pain, it is expected to reduce two points at any of the scales after intervention measures for pain reduction.<br>It is expected that this change occurs soon after the intervention and that they remain for 30 minutes after the end.
- Secondary Outcome Measures
Name Time Method Quantification of heart rate and blood pressure, evaluated by non invasive Dixtal monitor, it is expected to observe a 10% reduction in the basal value of these physiological variables after the intervention measures to reduce pain.<br>Evaluation of oxygenation by SpO2, non-invasive evaluation by Dixtal monitor with digital sensor, it is expected to observe an increase of 4 percentage points in the value of SpO2 after the intervention measures to reduce pain.<br>Measurement of the respiratory rate evaluated by the mechanical ventilator monitor, a reduction of 15 to 20% in this variable is expected after intervention measures to reduce pain.<br>These changes are expected to occur soon after the intervention and to be maintained for 30 minutes after the end of the intervention.