Recruiting

Nebulized N-Acetyl Cysteine

Sponsor:

Carilion Clinic

Code:

NCT03364218

Conditions

Bronchiolitis Acute

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Interventions

N-Acetyl Cysteine

Study Details

Brief summary:

Bronchiolitis is the major cause of hospital admission in infants < 6 months of age and usually viruses like Respiratory syncytial virus (RSV), human metapneumo virus, Adeno virus, para-influenza virus, Rhino virus and influenza virus are the main culprit. In the US, acute bronchiolitis in infancy is responsible for approximately 150,000 hospitalizations yearly at an estimated cost of $500 million. Globally in 2005 it was estimated that at least 33.8 million were affected with RSV and in the same year, RSV associated severe acute lower respiratory infection (ALRI) were responsible for \~3.4 million hospitalizations and 66,000-199,000 deaths worldwide, with 99% of these deaths in developing countries.

In acute bronchiolitis there is cellular swelling and excessive mucus production. There is also proliferation of goblet cells, which leads to increased mucus production. The excess mucus produced is poorly cleared by non-ciliated (regenerating) epithelial cells leading to areas of narrowing and blocking of the bronchioles, causing the airway obstruction, hyperinflation, increased airway resistance, atelectasis and increased ventilation-perfusion mismatch that characterize acute bronchiolitis.

Currently there is no medicine that has proven effective in treating acute bronchiolitis and per American Academy of Pediatrics guidelines the management of acute bronchiolitis remains supportive care for the acute respiratory failure associated with acute bronchiolitis.

N-Acetyl Cysteine (NAC) is an antioxidant, anti-mucus compound that increases intracellular glutathione at the cellular level. It cleaves disulfide bonds by converting them to two sulfhydryl groups. This action results in the breakup of mucoproteins in lung mucus, reducing their chain lengths and thinning the mucus. Nebulized NAC is not studied well in acute bronchiolitis and is uncommonly used for the same. NAC has been studied in the treatment of various disease states, including those pulmonary in nature such as cystic fibrosis, chronic bronchitis, non-cystic fibrosis bronchiectasis and found to be beneficial.

With this background knowledge, the purpose of this study is to evaluate the effectiveness of nebulized mucolytic therapy in treatment of children with viral bronchiolitis.

Conditions

Bronchiolitis Acute

Study ID

NCT03364218

Start date

Feb 1, 2018

Status verified date

Sep, 2019

Completion date

May 31, 2020

Anticipated

Primary completion date

May 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Full term new born neonates up to patients < 2yrs
  • Respiratory score ≥2
  • Otherwise healthy with new respiratory illness

Exclusion Criteria:

  • Prematurity <34 weeks for patients <6 months age.
  • h/o congenital heart disease requiring baseline medication
  • Patient received diagnosis of Asthma or reactive airway disease in past.
  • Anatomic airway defect.
  • Immunodeficiency
  • Chronic lung disease
  • Patients who have had previous bronchiolitis < 4 weeks ago
  • Patients intubated for acute bronchiolitis during the current admission.
  • h/o Larynogomlacia, bronchomalacia or tracheomalacia.

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Subjects will receive N-Acetyl Cysteine (NAC) nebulized 2 mL of 10% NAC solution every 12 hours during their stay in the Pediatric Intensive Care Unit.

no intervention: Control Group

Subjects will not receive NAC, but will receive standard care for acute bronchiolitis.

Interventions

N-Acetyl Cysteine

Nebulized N-Acetyl Cysteine administered every 12 hours

Primary outcome measure

  • Respiratory Score [ Time Frame: 1. Twice daily by physician 2. 15-30 min pre-treatment by nurse 3. 15-30 and 90 min post-treatment by nurse ]
  • Time on Non-Invasive Ventilation [ Time Frame: From time of PICU admission to time of PICU discharge, assessed up to 4 weeks ]
  • Duration of PICU/Hospital Admission [ Time Frame: From time of hospital admission to time of hospital discharge, assessed up to 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Carilion Clinic

Recruiting

Roanoke, Virginia, United States, 24014

Contacts

More Information

Sponsor

Carilion Clinic

Last update posted

Sep 26, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Carilion Clinic on 2019-09-26.