Trial · NCT01488448

A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis

NCT01488448, Not applicable, Completed, Montefiore Medical Center; results first posted 2014-08-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis. Trials, record NCT01488448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01488448

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Trial

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

Title: A Study of Hypertonic Saline for Infants Hospitalized With Bronchiolitis
NCT number: NCT01488448
Status: Completed
Phases: Not applicable
Enrollment: 227 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Bronchiolitis
Interventions: 3% sodium chloride, 0.9% sodium chloride
First posted: 2011-12-08
Last updated: 2017-02-02
Results first posted: 2014-08-22

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Length of Stay in the Study-LOS--Intention to Treat Analysis	Time of first study treatment until time of discharge	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.
Primary	Length of Stay in the Study-LOS by Per Protocol Analysis	Time of first study treatment until time of discharge	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.
Secondary	Readmission for Bronchiolitis Within 7 Days of Discharge	within 7 days of hospital discharge	Phone call at 7 days to assess for readmission to any hospital
Secondary	Clinical Worsening	though hospitalization/time period receiving study treatment, average 2-3 days	transfer to the Pediatric Intensive Care Unit (PICU) (including withdrawn from the study for bronchodilator administration who were then transferred to the PICU), or Respiratory Distress Assessment Instrument (RDAI) increase of 4 or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
Secondary	Total Adverse Events	Time of enrollment in the study through 1 week after hospital discharge	Clinical worsening events (defined prior) + 7 day readmissions

Source ClinicalTrials.gov

Outcomes9

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Length of Stay in the Study-LOS--Intention to Treat Analysis	Time of first study treatment until time of discharge	Intention to Treat Analysis	Days	MEDIAN
SECONDARY	Readmission for Bronchiolitis Within 7 Days of Discharge	within 7 days of hospital discharge	This population is those who completed the study.	participants	NUMBER
SECONDARY	Clinical Worsening	though hospitalization/time period receiving study treatment, average 2-3 days	all patients enrolled in the study were analyzed for events related to clinical worsening	participants	NUMBER
SECONDARY	Total Adverse Events	Time of enrollment in the study through 1 week after hospital discharge		adverse events	NUMBER
POST_HOC	LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)	through hospitalization/while receiving study medication, average 2-3 days	This is the population in the study whose RSV testing was positive.	days	MEDIAN
POST_HOC	LOS in Patients With a History of Previous Wheeze	through hospitalization/while receiving study medication, average 2-3 days	Subgroup of the study population who reported a history of wheezing prior to this admission	days	MEDIAN
POST_HOC	LOS Subgroup Analysis of Patients With a History of Prematurity	through hospitalization/while receiving study medication, average 2-3 days	Patients who reported a history of prematurity/whose Gestational age was \<37 weeks	days	MEDIAN
POST_HOC	LOS Analysis for Patients Whose Study Entry Respiratory Distress Assessment Instrument (RDAI) Was Greater Than or Equal to 4 or Who Had Hypoxia <92%	through hospitalization/while receiving study medication, average 2-3 days	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	days	MEDIAN
PRIMARY	Length of Stay in the Study-LOS by Per Protocol Analysis	Time of first study treatment until time of discharge	Per protocol analysis (only includes participants who completed the study)	Days	MEDIAN

Source ClinicalTrials.gov

Results by group18

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

Outcome	Group	Value	Spread	Units
Length of Stay in the Study-LOS--Intention to Treat Analysis	Hypertonic Saline	2.1	Inter-Quartile Range 1.2 to 4.6	Days
Length of Stay in the Study-LOS--Intention to Treat Analysis	Normal Saline	2.1	Inter-Quartile Range 1.2 to 3.8	Days
Readmission for Bronchiolitis Within 7 Days of Discharge	Nebulized Hypertonic Saline	4		participants
Readmission for Bronchiolitis Within 7 Days of Discharge	Nebulized Normal Saline	3		participants
Clinical Worsening	Hypertonic Saline	10		participants
Clinical Worsening	Normal Saline	9		participants
Total Adverse Events	Hypertonic Saline	14		adverse events
Total Adverse Events	Normal Saline	12		adverse events
LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)	Hypertonic Saline	2.2	Inter-Quartile Range 1.6 to 3.8	days
LOS in Subgroup of Patients With Testing Positive for Respiratory Syncitial Virus (RSV+)	Normal Saline	2.0	Inter-Quartile Range 1.2 to 3.2	days

1 to 10 of 18Source ClinicalTrials.gov

See all 18 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	113
Overall Study	STARTED	Normal Saline	114
Overall Study	COMPLETED	Hypertonic Saline	93
Overall Study	COMPLETED	Normal Saline	97
Overall Study	NOT COMPLETED	Hypertonic Saline	20
Overall Study	NOT COMPLETED	Normal Saline	17

Source ClinicalTrials.gov

Adverse events6

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
serious	Transfer to PICU	Respiratory, thoracic and mediastinal disorders	Hypertonic Saline	9	113
serious	Transfer to PICU	Respiratory, thoracic and mediastinal disorders	Normal Saline	3	114
serious	Readmission-respiratory	Respiratory, thoracic and mediastinal disorders	Hypertonic Saline	3	113
serious	Readmission-respiratory	Respiratory, thoracic and mediastinal disorders	Normal Saline	5	114
serious	Readmission-non-respiratory	Investigations	Hypertonic Saline	1	113
serious	Readmission-non-respiratory	Investigations	Normal Saline	2	114

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
Total, all-cause mortality	Normal Saline
Total, other adverse events	Hypertonic Saline	0	113
Total, other adverse events	Normal Saline	0	114
Total, serious adverse events	Hypertonic Saline	13	113
Total, serious adverse events	Normal Saline	10	114

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
26553190	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 Hypertonic Saline vs Nebulized Normal Saline: Readmission for Bronchiolitis Within 7 Days of Discharge	Trial comparisons
Hypertonic Saline vs Normal Saline: Clinical Worsening	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/NCT01488448

GET https://conductscience.org/api/trials/v1/NCT01488448/registered

API reference For AI assistants