Bronchiolitis Clinical Trial
Official title:
Effects of Photobiomodulation on the Innate Immune System of Neonates and Infants Diagnosed With Acute Respiratory Sintitial Virus Bronchiolitis - Randomized Controlled Trial
The innate immune response of children with acute viral bronchiolitis (AVB) caused by respiratory syncytial virus (RSV) in the acute phase and in the resolution phase, is marked by variations in inflammatory and anti-inflammatory mediators, where in the acute phase there is recruitment and activation of multiple cells of the immune system, with consequent increase in the expression of pro-inflammatory mediators. Evidence indicates that there is a considerable increase in tumor necrosis factor-alpha (TNF) , interleukine 6 (IL6), interleukine 1-beta, interleukine 8 (IL8) interleukine 10 (IL10), exposing to IL6, IL8 and IL-10 positively correlated with AVB severity. There are already reports that the transcutaneous application of photobiomodulation (PBM) reaches the lungs, producing positive responses in respiratory pathologies, both acute and chronic . Thus, PBM caused by the use of low-level laser may be a favorable resource to be used in the area of respiratory physiotherapy, specifically in neonatology and pediatrics, since there are studies in both experimental and human models that prove its action on lung cells, acting to reduce airway edema, reduce neutrophil migration to lung tissue and synthesize pro-inflammatory cytokines TNFalpha, IL6 and IL-10. In addition, it is a portable, practical, quick application, with minimal contraindications and possibly better tolerated by the neonatal and pediatric population.
Status | Not yet recruiting |
Enrollment | 44 |
Est. completion date | June 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Years |
Eligibility | Inclusion Criteria: - Diagnosis of AVB due to RSV confirmed on hospital admission examination Exclusion Criteria: - Diagnosis of congenital or acquired heart disease; - Pulmonary malformations; - Use of any number of doses of palivizumab or another immunobiological agent; - Present any "new pathology" during treatment with FBM; - Cancer of any histology; - Skin lesion near the application sites; - Desire to drop out of study. |
Country | Name | City | State |
---|---|---|---|
Brazil | Centro de Pesquisa e Pós Graduação na Unopar | Londrina | Paraná |
Lead Sponsor | Collaborator |
---|---|
Universidade Norte do Paraná |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Innate Immunological Markers | Due to the increase in nasotracheal secretion caused by AVB, nasotracheal aspiration is usually a routine procedure because it is often necessary to perform it to maintain the pervious airways, since in some cases children cannot properly manage the secretion. Thus, this procedure will be used to collect secretion on the first, fourth and eighth days of care, stored in a -80°C freezer and later sent for laboratory analysis of pro-inflammatory cytokines such as: tumor necrosis factor alpha (TNF), interleukin 6 (IL6), interleukin 1-beta, and anti-inflammatory interleukin 10 (IL10). Cytokine analysis will be performed by flow cytometry using the BD™ Cytometric Bead Array (CBA) kit. | 4th day of hospitalization and 8th or discharge day | |
Secondary | Severity of AVB | To assess the severity of AVB, the Wang score will be used, which evaluates four items: respiratory rate, presence of wheezing, presence of chest retractions, and general condition. The sum of the items generates a value from zero to 12, classifying AVB as mild, moderate and severe, with 12 being the greatest severity of the disease (WANG et al. 1992). This scale will be applied daily before physical therapy care during the hospitalization period in all participants. Along with the scale, the following will be recorded: respiratory rate, heart rate, temperature, peripheral O2 saturation, type oxygen therapy (interface and flow). | 1st day of hospitalization through 8th or discharge day | |
Secondary | Overall | General data will be collected, in a Google form (Google Corp. 2018), such as: current age, gestational age at birth, type of delivery, gender, duration of exclusive breastfeeding, previous diagnosis of respiratory diseases, previous hospitalizations, time and place of hospitalization (emergency room, ward, intensive care unit), use and time of use of oxygen therapy, use and time of use of invasive and/or non-invasive mechanical ventilation, if attending a daycare center or school, concomitant infection by other respiratory viruses, clinical picture, onset of symptoms, date of hospitalization and start of FBM application, skin color (phototype), presence of jaundice, total number of FBM applications, total number of physical therapy visits, medications used during hospitalization and medications used continuously at home. | 1st day of hospitalization through 8th or discharge day |
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