Trial Outcomes & Findings for Nebulized Hypertonic Saline for Bronchiolitis (NCT NCT00619918)

NCT ID: NCT00619918

Last Updated: 2024-11-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 447 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2024-11-05

Participant Flow

Subjects were recruited beginning March 2008 and April 2011, only during months of bronchiolitis season (November through April). Recruitment occurred in the emergency department and general medical inpatient units at 2 urban tertiary free-standing children's hospitals in the U.S.

No patients were excluded after enrollment but before randomization.

Participant milestones

Measure	Hypertonic Saline 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Overall Study STARTED	230	217
Overall Study COMPLETED	210	195
Overall Study NOT COMPLETED	20	22

Reasons for withdrawal

Measure	Hypertonic Saline 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Overall Study Withdrawal by Subject	4	3
Overall Study Physician Decision	2	4
Overall Study Transfer to outside facility	3	3
Overall Study Left before receiving first dose	7	6
Overall Study ICU admission	4	6

Baseline Characteristics

Nebulized Hypertonic Saline for Bronchiolitis

Baseline characteristics by cohort

Measure	Hypertonic Saline n=230 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=217 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Total n=447 Participants Total of all reporting groups
Age, Categorical <=18 years	230 Participants n=5 Participants	217 Participants n=7 Participants	447 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	0.55 years STANDARD_DEVIATION 0.42 • n=5 Participants	0.53 years STANDARD_DEVIATION 0.43 • n=7 Participants	0.54 years STANDARD_DEVIATION 0.44 • n=5 Participants
Sex: Female, Male Female	95 Participants n=5 Participants	98 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	135 Participants n=5 Participants	119 Participants n=7 Participants	254 Participants n=5 Participants
Region of Enrollment United States	230 participants n=5 Participants	217 participants n=7 Participants	447 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Analysis for this outcome only includes patients who were enrolled in the ED, and not patients enrolled in the inpatient setting.

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.

Outcome measures

Measure	Hypertonic Saline n=196 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=183 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Admission Rate Admitted	55 participants	76 participants
Admission Rate Discharged	141 participants	107 participants

PRIMARY outcome

Timeframe: 1 month

Population: Analysis for this outcome only includes patients who were admitted to inpatient status at the enrolling hospital and not transferred out.

Length of stay defined as date of discharge minus date of admission (whole days)

Outcome measures

Measure	Hypertonic Saline n=74 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=99 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Length of Stay	2.87 Days Standard Deviation 2.00	2.86 Days Standard Deviation 1.73

PRIMARY outcome

Timeframe: 1 Hour

Population: 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).

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.

Outcome measures

Measure	Hypertonic Saline n=217 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=201 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Change in RDAI Score	1.032 units on a scale Standard Deviation 2.087	0.8557 units on a scale Standard Deviation 1.650

SECONDARY outcome

Timeframe: 14 days

Population: Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)

Hours requiring supplemental oxygen for admitted patients.

Outcome measures

Measure	Hypertonic Saline n=70 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=87 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Hours of Oxygen Use	32.88 hours Standard Deviation 39.99	31.39 hours Standard Deviation 44.54

SECONDARY outcome

Timeframe: 14 days

Population: Excludes patients withdrawn by investigator due to ICU admission or ineligible condition (12), withdrawn by parent (6), and missing data (3)

IV fluid volume administered during entire hospitalization, in mL/kg

Outcome measures

Measure	Hypertonic Saline n=70 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=87 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
IV Fluid Use	51.38 mL/kg Standard Deviation 90.15	59.73 mL/kg Standard Deviation 107.10

SECONDARY outcome

Timeframe: 14 days

Population: 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.

patients who received supplemental albuterol, ipratropium, or epinephrine inhaled treatment (other than pre-treatment for study med)

Outcome measures

Measure	Hypertonic Saline n=231 Participants 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=216 Participants 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Number of Participants With Supplemental Medication Use	39 Participants	39 Participants

Adverse Events

Hypertonic Saline

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Hypertonic Saline n=231 participants at risk 3% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge	Normal Saline n=216 participants at risk 0.9% NaCl, 4 ml, via updraft wall nebulizer: * In ED: every 20 minutes up to 3 doses * In Inpatient: every 8 hours until discharge
Respiratory, thoracic and mediastinal disorders ICU admission	1.7% 4/231 • Number of events 4 • Patient enrollment through duration of hospitalization (average 3.5 days) The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.	2.8% 6/216 • Number of events 6 • Patient enrollment through duration of hospitalization (average 3.5 days) The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.
Respiratory, thoracic and mediastinal disorders Worsening cough	0.43% 1/231 • Number of events 1 • Patient enrollment through duration of hospitalization (average 3.5 days) The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.	0.93% 2/216 • Number of events 2 • Patient enrollment through duration of hospitalization (average 3.5 days) The number of participants at risk is different from the number started because one patient randomized to the normal saline group received hypertonic saline.

Additional Information

Susan Wu

Children's Hospital Los Angeles

Phone: 323-361-6177

Email: suwu@chla.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place