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Pain in preterm new born and physiotherapy.

Analysis of Neonatal Pain in Premature infants with Respiratory Distress Syndrome and its influence on physiological parameters and the Physiotherapeutic treatment hemodynamic in Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4233sv
Enrollment
Unknown
Registered
2018-01-23
Start date
2017-08-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm, Pain, Pulmonary disease.

Interventions

The volunteers included (No 120 in total) will be randomized into four groups described below. Thoracic Vibration experimental Group (GV): 30 group RNs premature infants with respiratory distress sy
Other
E02.779

Sponsors

Fundação Santa Casa de Misericórdia do Pará
Lead Sponsor
Universidade Nove de Julho
Collaborator

Eligibility

Age
3 Days to 3 Months

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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. It is expected that this change occurs soon after the intervention and that they remain for 30 minutes after the end.

Secondary

MeasureTime frame
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. 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. 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. These changes are expected to occur soon after the intervention and to be maintained for 30 minutes after the end of the intervention.

Countries

Brazil

Contacts

Public ContactFernanda Lanza

Universidade Nove de Julho

lanzafe@gmail.com55 11 33859226

Outcome results

None listed

Source: REBEC (via WHO ICTRP)