Effects of Photobiomodulation on the Innate Immune System of Neonates and Infants With Bronchiolitis

NCT06396624 | Not Yet Recruiting

• 1 other identifier: MazzoDM_PHD_FurlanettoKC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis; Virus; Virus Disease

Keywords

Bronchiolitis; Photobiomodulation; Low Level Light Therapy; Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Severity of AVB

  1st day of hospitalization through 8th or discharge day

• Overall

  1st day of hospitalization through 8th or discharge day

Study Arms (2)

Intervention Group

EXPERIMENTAL

The application of FBM will take place immediately after the conventional physical therapy maneuvers as recommended by the institution's physical therapist, following the institution's protocols. The patient may be positioned in bed or on the lap of the person in charge, in the way that is most comfortable for him/her, with the chest bare. The eyes of the patient, the person in charge and the physiotherapist must be properly protected by the use of appropriate glasses to avoid contact with the light beam emitted by the equipment. The application will be punctual, perpendicular to the thorax, using the portable photobiomodulation device Therapy EC - (DMC equipamentos - São Carlos-SP. ANVISA Registration: 80030819013) in continuous mode, with a power of 100mW, 808nm wavelenght, 4J of energy and 40s of irradiation per point.

Radiation: Intervention Group photobiomodulation

Control Group

PLACEBO COMPARATOR

The control group will be treated in the same way as the intervention group, as recommended by the institution's physiotherapist, following its protocols. The same photobiomodulation device will be used as a placebo, but turned off, with a lock on the tip to ensure that no light beam is emitted. The device will be wrapped in PVC plastic film that allows it to be cleaned and changed when used in different patients, avoiding possible contamination. The same irradiation points will be used as in the control group (Figures 2 and 3). The patient may be positioned in bed or on the lap of the person in charge, in the way that is most comfortable for him/her, with the chest bare. The eyes of the patient, the caregiver and the physiotherapist must be properly protected.

Other: Control Group

Interventions

Intervention Group photobiomodulation RADIATION

Seven spots on child's thorax and two spots on the face will be irradiated with 40s per point of photobiomodulation.

Also known as: Photobiomodulation, Low level light therapy, Low level laser

Intervention Group

Control Group OTHER

The photobiomodulation device will positioned in seven spots on thorax and two in child's face, but it will not emit any time of radiation, since the device will be turned off.

Control Group

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of AVB due to RSV confirmed on hospital admission examination

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Norte do Paraná: lead

Study Sites (1)

Centro de Pesquisa e Pós Graduação na Unopar

Londrina, Paraná, 86041-14, Brazil

Location

MeSH Terms

Conditions

Bronchiolitis; Virus Diseases

Interventions

Low-Level Light Therapy; Control Groups

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Débora Mazzo, MsC

CONTACT

+55 042 999610722; deborammazzo@gmail.com

Karina Furlanetto, PhD

CONTACT

+5543991144621; karina.furlanetto@cogna.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: May 2, 2024
• Study Start: June 18, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)