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Efficacy Of Combined Nebulized Hypertonic Saline and Chest Percussion Therapy in Acute Viral Bronchiolitis

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NYU Langone Health

Status and phase

Enrolling
Phase 4

Conditions

Acute Bronchiolitis

Treatments

Drug: Nebulized 3% sodium chloride solution
Device: Chest percussion cups

Study type

Interventional

Funder types

Other

Identifiers

NCT06441162
23-01357

Details and patient eligibility

About

This study will examine the efficacy of combined nebulized hypertonic saline with chest percussion therapy in patients age 0 to 24 months admitted to the general inpatient pediatrics unit with acute bronchiolitis. 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy will be administered every 6 hours of patients selected for the study.

Enrollment

114 estimated patients

Sex

All

Ages

Under 24 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study (experimental arm), an individual must meet all of the following criteria:

  • Age 0 to 24 months
  • Admitted to the general inpatient pediatrics unit
  • Has a diagnosis of acute bronchiolitis
  • Receiving supplemental oxygen support

Data collected for the control arm will be obtained via retrospective chart review for patients meeting the following inclusion criteria:

  • Age 0 to 24 months
  • Admitted to the general inpatient pediatrics unit
  • Has a diagnosis of acute bronchiolitis
  • Receiving supplemental oxygen support

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Admitted to the pediatric intensive care unit
  • Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
  • Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
  • Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
  • Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
  • Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics

A potential study subject in the control arm via retrospective chart review who meets any of the following criteria will be excluded from this study:

  • Admitted to the pediatric intensive care unit
  • Has an underlying pre-existing condition that may affect the respiratory system (includes bronchopulmonary dysplasia, reactive airways disease, asthma, restrictive lung diseases, other chronic lung diseases, etc.)
  • Has other comorbid conditions upon admission that may affect the respiratory system (includes pneumonia or other bacterial or fungal lung infections, acute exacerbation of reactive airways disease, acute exacerbation of asthma, pulmonary edema, pleural effusion, etc.)
  • Has an absolute contraindication to nebulized 3% hypertonic saline, for example, a history of an allergic or anaphylactic reaction
  • Is receiving other respiratory treatments such as bronchodilator treatments (i.e. albuterol or levalbuterol)
  • Is receiving other adjuvant therapy such as antibiotics, antivirals, glucocorticoids, corticosteroids, or diuretics

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

Nebulized Hypertonic Saline + Chest Percussion Therapy
Experimental group
Description:
Participants with acute viral bronchiolitis will receive 3% nebulized hypertonic saline treatments combined with 3 minutes of chest percussion therapy. This will be administered every 6 hours.
Treatment:
Device: Chest percussion cups
Drug: Nebulized 3% sodium chloride solution
Control Arm
No Intervention group
Description:
Participants in the control arm will be analyzed via retrospective chart review; these participants will not be consented nor enrolled in the trial.

Trial contacts and locations

1

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Central trial contact

Tuan Nguyen

Data sourced from clinicaltrials.gov

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