Trial Outcomes & Findings for A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis (NCT NCT01488448)

NCT ID: NCT01488448

Last Updated: 2017-02-02

Results Overview

Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 227 participants
• Primary outcome timeframe: Time of first study treatment until time of discharge
• Results posted on: 2017-02-02

Participant Flow

Participant milestones

Measure	Hypertonic Saline 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Overall Study STARTED	113	114
Overall Study COMPLETED	93	97
Overall Study NOT COMPLETED	20	17

Reasons for withdrawal

Measure	Hypertonic Saline 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Overall Study Withdrawal by Subject	3	1
Overall Study Adverse Event	9	4
Overall Study Physician Decision	4	9
Overall Study Protocol Violation	4	3

Baseline Characteristics

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

Baseline characteristics by cohort

Measure	Hypertonic Saline n=113 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=114 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge	Total n=227 Participants Total of all reporting groups
Age, Continuous	3.86 months STANDARD_DEVIATION 3.01 • n=5 Participants	4.39 months STANDARD_DEVIATION 2.95 • n=7 Participants	4.1 months STANDARD_DEVIATION 2.98 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	42 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	77 Participants n=5 Participants	72 Participants n=7 Participants	149 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time of first study treatment until time of discharge

Population: Intention to Treat Analysis

Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.

Outcome measures

Measure	Hypertonic Saline n=111 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=111 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Length of Stay in the Study-LOS--Intention to Treat Analysis	2.1 Days Interval 1.2 to 4.6	2.1 Days Interval 1.2 to 3.8

PRIMARY outcome

Timeframe: Time of first study treatment until time of discharge

Population: Per protocol analysis (only includes participants who completed the study)

Length of stay will be defined by the duration between the time of first study treatment to the time a discharge order is placed. Alternatively, if a patient remains inpatient for other, non-bronchiolitis related reasons (i.e. social reasons, etc.) the time a patient could be discharged from the standpoint of bronchiolitis as documented by the attending, will be used.

Outcome measures

Measure	Hypertonic Saline n=93 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=97 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Length of Stay in the Study-LOS by Per Protocol Analysis	2.0 Days Interval 1.3 to 3.3	2.0 Days Interval 1.2 to 3.0

SECONDARY outcome

Timeframe: within 7 days of hospital discharge

Population: This population is those who completed the study.

Phone call at 7 days to assess for readmission to any hospital

Outcome measures

Measure	Hypertonic Saline n=93 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=97 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Readmission for Bronchiolitis Within 7 Days of Discharge	4 participants	3 participants

SECONDARY outcome

Timeframe: though hospitalization/time period receiving study treatment, average 2-3 days

Population: all patients enrolled in the study were analyzed for events related to clinical worsening

transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or more points within 30 minutes of a study treatment

Outcome measures

Measure	Hypertonic Saline n=113 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=114 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Clinical Worsening	10 participants	9 participants

SECONDARY outcome

Timeframe: Time of enrollment in the study through 1 week after hospital discharge

Clinical worsening events (defined prior) + 7 day readmissions

Outcome measures

Measure	Hypertonic Saline n=93 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=97 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
Total Adverse Events	14 adverse events	12 adverse events

POST_HOC outcome

Timeframe: through hospitalization/while receiving study medication, average 2-3 days

Population: This is the population in the study whose RSV testing was positive.

Outcome measures

Measure	Hypertonic Saline n=69 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=59 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)	2.2 days Interval 1.6 to 3.8	2.0 days Interval 1.2 to 3.2

POST_HOC outcome

Timeframe: through hospitalization/while receiving study medication, average 2-3 days

Population: Subgroup of the study population who reported a history of wheezing prior to this admission

Outcome measures

Measure	Hypertonic Saline n=14 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=21 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
LOS in Patients With a History of Previous Wheeze	1.7 days Interval 1.1 to 2.6	2.0 days Interval 1.2 to 3.2

POST_HOC outcome

Timeframe: through hospitalization/while receiving study medication, average 2-3 days

Population: Patients who reported a history of prematurity/whose Gestational age was \<37 weeks

Outcome measures

Measure	Hypertonic Saline n=11 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=15 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
LOS Subgroup Analysis of Patients With a History of Prematurity	2.9 days Interval 1.9 to 3.6	2.2 days Interval 1.2 to 3.2

POST_HOC outcome

Timeframe: through hospitalization/while receiving study medication, average 2-3 days

Population: Subgroup of patients who had a study entry Respiratory Distress Assessment Instrument (RDAI) of greater than or equal to 4 points OR hypoxia \<92% on admission

Outcome measures

Measure	Hypertonic Saline n=62 Participants 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=67 Participants 4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%	2.1 days Interval 1.3 to 4.1	2.1 days Interval 1.3 to 3.7

Adverse Events

Hypertonic Saline

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Hypertonic Saline n=113 participants at risk 4 mL nebulized 3% sodium chloride every 4 hours until discharge	Normal Saline n=114 participants at risk 4mL nebulized 0.9% sodium chloride every 4 hours until discharge
Respiratory, thoracic and mediastinal disorders Transfer to PICU	8.0% 9/113	2.6% 3/114
Respiratory, thoracic and mediastinal disorders Readmission-respiratory	2.7% 3/113	4.4% 5/114
Investigations Readmission-non-respiratory	0.88% 1/113	1.8% 2/114

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alyssa Silver

Children's Hospital at Montefiore/Albert Einstein College of Medicine

Phone: 718-741-2304

Email: alysilve@montefiore.org

Results disclosure agreements

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