A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis.

A randomized, multicenter, controlled trial of the effectiveness of nebulized therapy with 3% hypertonic saline solution compared with 0.9% saline solution in hospitalized infants with RS viral bronchiolitis. - Nebulized 3% hypertonic saline solution treatment in hospitalized infants with RS viral bronchiolitis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001700

Enrollment

120

Registered

2009-02-10

Start date

2008-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RS viral bronchiolitis

Interventions

nebulized 3% saline solution + beta stimulator nebulized 0.9% saline solution + beta stimulator

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)The patient of the RS virus infectious disease with Rspositive rirus antigen swiftness kit. 2)A patient diagnosed acute bronchiolitis by physicians with following i) and ii). i)the first episode of wheezing ii)The patient has either of rhinorrhea, coughing, tachypnea, retractive breathing or decreased breath sounds on auscultation. 3)A patient equal to or less than age 12 months 4)A patient need hospitalization. 5)Written informed consent from the patients' parents or legal guardians.

Exclusion criteria

Exclusion criteria: 1)pCO2 is more than 60 mm Hg by venous blood gas or SpO2 is under 95 % under administration of oxygen. 2)diagnosed episode of wheezing previously. 3)Cerebral palsy, congenital heart desease, lung disease, muscular disorder, malformed syndrome, immune deficiency disorder 4)a patient who was born by premature birth equal to or less than several a week 35 weeks for gestational ages 5)a patients administrated palivizumab. 6)a patients with apnea 7)Judged a patients needed intubation by the physicians. 8)Judged inappropriate for this study by the physicians.

Design outcomes

Primary

Measure	Time frame
length of hospital stay; time to satisfy discharge criteria	—

Secondary

Measure	Time frame
Actual length of hospital stay Change of clinical severity score of hospitalization and 72hr plus and minus 12hr after hospitalization Duration of O2 administration Number of additional inhalation Rate of ventilator use	—

Countries

Japan

Contacts

Public ContactYoshihiko Morikawa

Tokyo Metropolitan Children's medical center Hospital Department of clinical research

042-300-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026