A Phase 4 interventional study of Nebulized 3% saline and Nebulized 0.9% Normal Saline in Bronchiolitis, Viral and Saline Solution, Hypertonic, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 2 Months to 23 Months. Per ClinicalTrials.gov, last updated 2014-08-19.
Sponsored by Children's Hospital of Philadelphia · Phase 4, Interventional, and Treatment
The purpose of this study is to determine whether nebulized 3% hypertonic saline (HS) improves respiratory distress in children 2-23 months presenting to the emergency department (ED) with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.
Acute bronchiolitis is the most frequent cause of infant hospitalization in the United States. Bronchiolitis typically refers to a viral lower respiratory tract infection during the first two years of life manifesting as a constellation of clinical symptoms including wheezing, cough and respiratory distress. In addition to a tremendous disease burden, bronchiolitis admissions in the United States cost more than $500 million each year.
The primary pathophysiologic processes in bronchiolitis include airway wall and peribronchial inflammation, increased mucous production, sloughing of necrotic epithelial cells, and impaired airway clearance. These processes result in airway obstruction, gas trapping, atelectasis and impaired gas exchange. Standard therapies for bronchiolitis remain supportive, including maintaining hydration and nutrition, ensuring adequate oxygenation, and physical suctioning of the nasal airways to clear secretions. Therapies such as the bronchodilator albuterol, although commonly used in standard practice, have not been proven to impact progression of disease or improve long-term outcomes of bronchiolitis.
Nebulized hypertonic saline (HS) has been shown to increase mucociliary clearance in the airways of individuals with healthy lungs. In addition nebulized HS increases airway clearance for disease processes including asthma, cystic fibrosis and bronchiectasis. A recent Cochrane review examined 4 small studies that suggest that nebulized 3% HS may reduce length of hospital stay and improve clinical severity scores in infants with acute viral bronchiolitis. None of these studies have explored the use of nebulized HS in the emergency department (ED). A recent study examined the use of a single nebulized treatment of epinephrine mixed in 3% HS in 46 infants less than 12 months presenting to the ED with bronchiolitis. This study did not find a difference between epinephrine diluted in normal saline compared to epinephrine diluted in 3% HS. Despite no effect on clinical score, the investigators did note a trend toward decreased rates of hospitalization. Furthermore, since this was the first ED study and the first negative study, the authors concluded that further investigation is necessary to determine if HS has a role in the management of acute bronchiolitis.
The purpose of the current study is to determine whether nebulized 3% HS improves respiratory distress in children 2-23 months presenting to the ED with acute bronchiolitis with persistent respiratory distress after initial therapy with a trial of nebulized albuterol.
Given the tremendous clinical and financial burden of bronchiolitis, any effective therapy, particularly one that is inexpensive, has the potential to result in significant health care savings. If nebulized 3% HS improved clinical scores in the ED, this may provide an inexpensive, safe and effective therapy for children with bronchiolitis in the acute care setting.
30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.
This study's enrollment of 62 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.
Browse Bronchiolitis, Viral studies →Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Nebulized 3% saline
Drug: Nebulized 0.9% Normal Saline
4 mL of nebulized 3% saline once
Also known as: 3% Hypertonic Saline Solution for Inhalation
4 mL of 0.9% nebulized normal saline once
Also known as: 0.9% Saline Solution for Inhalation
Respiratory Assessment Change Score (RACS)
The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.
Time frame: Baseline and 1 hour
Rate of Hospitalization
Time frame: 1 day
Respiratory Rate Change
Time frame: Baseline and 1 hour
Oxygen Saturation Change
Time frame: Baseline and 1 hour
Parental Perception of Improvement of Breathing After Study Medication
Time frame: 1 hour
| Milestone | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Started | 31 | 31 |
| Completed | 31 | 31 |
| Not completed | 0 | 0 |
The Respiratory Assessment Change Score (RACS) assesses change in respiratory status using the change in the Respiratory Distress Assessment Instrument (RDAI) and a standardized change in respiratory rate, with points being assigned by change increments of 10%. Thus, a change in respiratory rate of ≤5% from baseline counted as a change of 0 units, decrease/increase of 6% to 15% counted as improvement/deterioration of 1 unit, etc. The overall RACS is the arithmetic sum of the RDAI change and the standardized respiratory rate change between assessments with a decrease in RACS signifying improvement.
| units on a scale | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Respiratory Assessment Change Score (RACS) | -1.5 (-3.1 to 0.2) | -4 (-5.3 to -2.7) |
| percentage of participants | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Rate of Hospitalization | 71 | 64.5 |
| breaths per minute | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Respiratory Rate Change | -1.8 (-6.5 to 2.8) | -9.8 (-14.6 to -4.9) |
| percent | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Oxygen Saturation Change | 1.1 (-0.4 to 2.6) | 0.1 (-1.6 to 1.8) |
| percentage of participants | Nebulized 3% Saline | Nebulized 0.9% Normal Saline |
|---|---|---|
| Parental Perception of Improvement of Breathing After Study Medication | 50 | 54.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebulized 3% Saline | — | 0/31 (0%) | 0/31 (0%) |
| Nebulized 0.9% Normal Saline | — | 0/31 (0%) | 0/31 (0%) |
| Age, Continuous(months) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| Mean | 7.2 ± 5.1 | 6.1 ± 3.6 | 6.6 ± 4.3 |
| Sex: Female, Male(Participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| Female | 16 | 18 | 34 |
| Male | 15 | 13 | 28 |
| Race/Ethnicity, Customized(participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| African-American | 24 | 23 | 47 |
| White | 3 | 3 | 6 |
| Hispanic | 1 | 5 | 6 |
| Asian | 2 | 0 | 2 |
| Missing | 1 | 0 | 1 |
| Eczema History(participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| Yes | 8 | 7 | 15 |
| No | 21 | 23 | 44 |
| Unknown | 2 | 1 | 3 |
| Family History of Atopy(participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| No | 7 | 6 | 13 |
| Yes | 22 | 24 | 46 |
| Unknown | 2 | 1 | 3 |
| Days of Symptoms(days) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| Mean | 3.4 ± 3.7 | 3.4 ± 2.4 | 3.4 ± 3.1 |
| Smokers in Household(participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| No | 14 | 17 | 31 |
| Yes | 17 | 13 | 30 |
| Unknown | 0 | 1 | 1 |
| ICU History(participants) | Nebulized 3% Saline | Nebulized 0.9% Normal Saline | Total |
|---|---|---|---|
| No | 23 | 27 | 50 |
| Yes | 6 | 4 | 10 |
| Unknown | 2 | 0 | 2 |
5 further baseline measures are reported on the registry.
The record gives a start of Oct 2010, a primary completion of Dec 2011 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 2 years 8 months after primary completion.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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