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A CLINICAL TRIAL TO STUDY THE EFFECTS OF TWO NEBULISATIONS, 3% SODIUM CHLORIDE PLUS ADRENALINE NEBULISATION AND 3% SODIUM CHLORIDE NEBULISATION ALONE IN CHILDREN WITH LOWER RESPIRATORY TRACT INFECTIONS SPECIALLY BRONCHIOLITIS

A PROSPECTIVE RANDOMIZED CONTROLLED SINGLE BLINDED STUDY TO ANALYZE THE EFFICACY OF COMBINATION OF 3%NaCl AND ADRENALINE NEBULISATION IN COMPARISON WITH 3%NaCl NEBULISATION ALONE IN CHILDREN FROM 4WEEKS TO 24 MONTHS WITH ACUTE LOWER RESPIRATORY TRACT INFECTION WITH SPECIAL REFERENCE TO BRONCHIOLITIS IN PEDIATRIC WARD OF A TERTIARY CARE TEACHING HOSPITAL

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016093
Enrollment
50
Registered
2018-10-22
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: J219- Acute bronchiolitis, unspecified

Interventions

Intervention1: adrenaline: adrenaline nebulisation given along with 3%nacl nebulisation 6 hourly Control Intervention1: 3%nacl: 3%nacl nebulisation given alone every 6 hourly

Sponsors

DR B ADITHYA NIKHILESHWAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All cases of lower respiratory tract infection confirmed by chest x ray 2. All cases of bronchiolitis with a Respiratory Distress Assessment Instrument (RDAI)10score of 4 to 15 [on a scale of 0 (mild) to 17 (severe)].

Exclusion criteria

Exclusion criteria: 1. Had a previous episode of wheezing 2. Children less than 1 month of age 3. Known case of chronic cardiopulmonary disease 4. Immunodeficient 5. Present with pulse > 200/min, respiratory rate > 80/min, Spo2 6. Preterms with corrected age of less than 4 weeks at presentation 7. Parents have not given consent 8. Received oral or inhaled corticosteroids during the preceding 2 weeks 9. Recipients of any inhaled drug therapy for the current disease

Design outcomes

Primary

MeasureTime frame
Outcomes will be measured in terms of improvement in oxygen saturation, clinical assessment including RDAI score and the duration of hospital stayTimepoint: EVERYDAY TILL DAY OF DISCHARGE

Secondary

MeasureTime frame
utcomes will be measured in terms of improvement in oxygen saturation, clinical assessment including RDAI score and the duration of hospital stayTimepoint: 1-2 days

Countries

India

Contacts

Public ContactB ADITHYA NIKHILESHWAR

GOVERNMENT MEDICAL COLLEGE, BHAVNAGAR

jayukids@yahoo.com9824090049

Outcome results

None listed

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