A clinical trial to study the effect of nebulized hypertonic saline as compared to normal saline in infants and children with bronchiolitis

Study of nebulized hypertonic saline in the treatment of bronchiolitis in infants and children.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/003065

Enrollment

120

Registered

2011-01-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Bronchiolitis in infants and children

Interventions

Intervention1: Hypertonic saline: nebulised Control Intervention1: Normal saline: nebulised

Eligibility

Inclusion criteria

Inclusion criteria: Consecutive patients of moderate to severe bronchiolitis, aged two months to two years, of either sex, admitted to the hospital during the study period.

Exclusion criteria

Exclusion criteria: a) Gestational age at birth<34 weeks or requiring ventilation in newborn period. b) Underlying chronic cardiac or pulmonary or renal disease c) Wheezing episodes in the past. d) Very sick children with saturation<85% in room air, heart rate>200/min, respiratory rate>100/mm, obtunded consciousness, and or progressive respiratory failure requiring ventilation. e) Prior home bronchodilator or antibiotic use

Design outcomes

Primary

Measure	Time frame
Duration of stayTimepoint: The time between study entry (within 12 hrs of admission to hospital) and the time at which the infant reached protocol defined discharge criteria as measured by study physician	—

Secondary

Measure	Time frame
Change in clinical severity scores Timepoint: After nebulisation, on D2 and D3;Change in hemoglobin saturation (pulse oximetry)Timepoint: after nebulisation, on D2 and D3	—

Countries

India

Contacts

Public ContactLopamudra Mishra

lopamudra83.cmc@gmail.com8981484648

Outcome results

None listed

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