Trial · NCT00619918

Nebulized Hypertonic Saline for Bronchiolitis

NCT00619918, Phase 2, Phase 3, Completed, Children's Hospital Los Angeles; results first posted 2013-10-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nebulized Hypertonic Saline for Bronchiolitis. Trials, record NCT00619918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00619918

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nebulized Hypertonic Saline for Bronchiolitis
NCT number: NCT00619918
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 447 participants, actual
Lead sponsor: Children's Hospital Los Angeles
Conditions: Bronchiolitis
Interventions: Nebulized 3% saline, Nebulized 0.9% saline
First posted: 2008-02-21
Last updated: 2024-11-05
Results first posted: 2013-10-10
Limitations and caveats: * Albuterol administered before each study treatment~* Did not reach subject accrual goals~* Number of patients recruited from inpatient unit too small to analyze separately

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Admission Rate	1 day	Patients enrolled in the ED who required inpatient admission. Patients who required admission but were transferred to another facility due to lack of available beds were considered admitted for this outcome. Note, neither study site has an observation unit.
Primary	Length of Stay	1 month	Length of stay defined as date of discharge minus date of admission (whole days)
Primary	Change in RDAI Score	1 Hour	The Respiratory Distress Assessment Instrument (RDAI) is a respiratory severity score ranging from a low score of 0 to maximum score of 17. Lower scores indicate more mild symptoms; mild disease (0-6), moderate disease (7-11), and severe (12-17). A decrease in score of 2 is considered clinically significant improvement.
Secondary	Hours of Oxygen Use	14 days	Hours requiring supplemental oxygen for admitted patients.
Secondary	IV Fluid Use	14 days	IV fluid volume administered during entire hospitalization, in mL/kg
Secondary	Number of Participants With Supplemental Medication Use	14 days	patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Admission Rate	1 day	Analysis for this outcome only includes patients who were enrolled in the ED, and not patients enrolled in the inpatient setting.	participants	NUMBER
PRIMARY	Length of Stay	1 month	Analysis for this outcome only includes patients who were admitted to inpatient status at the enrolling hospital and not transferred out.	Days	MEAN
PRIMARY	Change in RDAI Score	1 Hour	Excludes patients who did not receive any doses of study medication (17), patients missing pre-tx score (7), post-tx score (4), or both (1).	units on a scale	MEAN
SECONDARY	Hours of Oxygen Use	14 days	Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)	hours	MEAN
SECONDARY	IV Fluid Use	14 days	Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)	mL/kg	MEAN
SECONDARY	Number of Participants With Supplemental Medication Use	14 days	230 patients were allocated to the 3% group; one patient allocated to the 0.9% group received 3% so was added to the 3% group for analysis, totaling 231 patients. The 0.9% group originally had 217 patients but after moving this patient to the 3% group, there are now 216 patients in the 0.9% group.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Admission Rate	Hypertonic Saline	Admitted	55		participants
Admission Rate	Normal Saline	Admitted	76		participants
Admission Rate	Hypertonic Saline	Discharged	141		participants
Admission Rate	Normal Saline	Discharged	107		participants
Length of Stay	Hypertonic Saline		2.87	Standard Deviation 2.00	Days
Length of Stay	Normal Saline		2.86	Standard Deviation 1.73	Days
Change in RDAI Score	Nebulized 3% Saline		1.032	Standard Deviation 2.087	units on a scale
Change in RDAI Score	Nebulized 0.9% Saline		0.8557	Standard Deviation 1.650	units on a scale
Hours of Oxygen Use	Nebulized 3% Saline		32.88	Standard Deviation 39.99	hours
Hours of Oxygen Use	Nebulized 0.9% Saline		31.39	Standard Deviation 44.54	hours

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Hypertonic Saline	230
Overall Study	STARTED	Normal Saline	217
Overall Study	COMPLETED	Hypertonic Saline	210
Overall Study	COMPLETED	Normal Saline	195
Overall Study	NOT COMPLETED	Hypertonic Saline	20
Overall Study	NOT COMPLETED	Normal Saline	22

Source ClinicalTrials.gov

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	ICU admission	Respiratory, thoracic and mediastinal disorders	Hypertonic Saline	4	231	4
other	ICU admission	Respiratory, thoracic and mediastinal disorders	Normal Saline	6	216	6
other	Worsening cough	Respiratory, thoracic and mediastinal disorders	Hypertonic Saline	1	231	1
other	Worsening cough	Respiratory, thoracic and mediastinal disorders	Normal Saline	2	216	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Hypertonic Saline	0	231
Total, all-cause mortality	Normal Saline	0	216
Total, other adverse events	Hypertonic Saline	5	231
Total, other adverse events	Normal Saline	8	216
Total, serious adverse events	Hypertonic Saline	0	231
Total, serious adverse events	Normal Saline	0	216

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24862623	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nebulized 3% Saline vs Nebulized 0.9% Saline: Number of Participants With Supplemental Medication Use	Trial comparisons
Hypertonic Saline vs Normal Saline: deaths from any cause	Trial comparisons
Hypertonic Saline vs Normal Saline: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00619918

GET https://conductscience.org/api/trials/v1/NCT00619918/registered

API reference For AI assistants