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Effect of 7% hypertonic saline in bronchiolitis

Efficacy and safety of nebulized 7% hypertonic saline in the treatment of acute bronchiolitis :A randomised control trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/048606
Enrollment
74
Registered
2022-12-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: J219- Acute bronchiolitis, unspecified

Interventions

Intervention1: 7% hypertonic saline: 7% hypertonic saline(4ml) + 1:1000 epinephrine (0.5ml/kg) every 6 hourly for 72 hours or until discharge (whichever is earlier) Control Intervention1: Control grou

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 1-24 months of age 2. Diagnosed with bronchiolitis- defined as viral prodrome for 2-3 days followed by LRTI as tachypnea, bilateral wheeze/ crepitations with or without crepitations 3. Bronchiolitis severity score more than or equal to 4

Exclusion criteria

Exclusion criteria: 1. A previous history of wheezing/ diagnosis of asthma 2.Any use of bronchodilators within 2 hours of presentation 3.History of congenital heart disease/ chronic pulmonary disease

Design outcomes

Primary

MeasureTime frame
Length of hospital stay: from the time of enrollment to ready to discharge (i.e when child is clinically active, alert, accepting feed, Spo2 more than92% on room air, absence of general danger signs and parents ready to care at homeTimepoint: BSS at baseline, every 6 hrs, 72 hrs or discharge time

Secondary

MeasureTime frame
1. Change in BSS score at 24, 48 and 72 hours or at discharge( whichever is earlier) 2. Need for respiratory support (HFNC/NIV/CPAP/MECHANICAL VENTILATION) 3.Complication rate following therapy 4 Safety profile and adverse effectsTimepoint: BSS score at 24, 48 and 72 hours

Countries

India

Contacts

Public ContactDR PRAWIN KUMAR

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

drprawin484@gmail.com9540084230

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026