Infant
Conditions
Interventions
This is a randomized, controlled, blinded feasibility clinical trial with two parallel arms. Infants with acute viral bronchiolitis hospitalized in a pediatric ward will participate and will be divide
the experimental group will undergo treatment with the Expector® LAC running all motors at a frequency of approximately 13 Hz (25% of the device’s total available frequency) at the minimum intensity r
Sponsors
Faculdade de Ciências da Saúde do Trairi da Universidade Federal do Rio Grande do Norte
Hospital Universitário Ana Bezerra da Universidade Federal do Rio Grande do Norte
Eligibility
Age
29 Days to 2 Years
Inclusion criteria
Inclusion criteria: Infants; both sexes; diagnosed with Acute viral bronchiolitis; hospitalized in a healthcare facility; parents or legal guardians must be at least 18 years old and must authorize the participation of the minors as well as their own by signing the Informed Consent Form
Exclusion criteria
Exclusion criteria: Infants with congenital musculoskeletal abnormalities in the thoracic region such as Kyphoscoliosis; presence of pre-existing cardiorespiratory disorders such as congenital heart diseases and Cystic fibrosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the sleep–wake state using the assessment form record, selecting one of the following options: alert, drowsy, or asleep;To evaluate infant comfort, measured by pain assessment, using the Children and Infants' Postoperative Pain Scale (CHIPPS). In Brazil, CHIPPS was validated in 2008 for use in children aged 0 to 5 years and is based on five behavioral categories: crying, facial expression, trunk posture, leg posture, and motor restlessness. Each item is scored from 0 to 2, with 0 indicating no signs of pain, 1 indicating potential pain, and 2 indicating definite pain. A score of 4 or greater suggests significant pain, which may require analgesic intervention;To evaluate caregivers' perception of comfort and acceptance of the device using a questionnaire specifically developed for this purpose. This instrument includes items related to handling the device (placing and removing it), the caregiver's subjective observation of both their own and the child’s comfort after 5, 10, and 15 minutes of use, evaluation of the device’s perceived benefit, and the overall level of satisfaction with the device | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the respiratory distress using the Respiratory Distress Assessment Instrument (RDAI). The RDAI was developed to evaluate the response of wheezing infants to epinephrine. It assesses wheezing on lung auscultation (inspiration, expiration, and location) and retractions (supraclavicular, intercostal, and subcostal). The total score ranges from 0 to 17 points, with higher scores indicating more severe conditions;To assess the amount of aspirated secretion using a precision scale;To evaluate respiratory rate by visually counting respiratory movements over one minute;To assess heart rate using a pulse oximeter;To assess peripheral oxygen saturation using a pulse oximeter;To assess pulmonary auscultation using a stethoscope positioned on the participant’s chest | — |
Countries
BR
Contacts
Public ContactKarolinne Monteiro
Faculdade de Ciências da Saúde do Trairi da Universidade Federal do Rio Grande do Norte
Outcome results
None listed