Skip to content

A study to compare hypertonic saline nebulization versus bicarbonate nebulization for improving lung function in children with cystic fibrosis

Bicarbonate versus hypertonic saline nebulization for improving lung function in children with cystic fibrosis: A randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075492
Enrollment
60
Registered
2024-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Health Condition 1: J479- Bronchiectasis, uncomplicated

Interventions

Intervention1: 8.4% Sodium bicarbonate nebulization: 4ml solution of 8.4% sodium bicarbonate nebulization will be used for nebulization for enrolled patients twice daily for 3 months. Nebulization wi

Sponsors

AIIMS Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children 5-18 years of age, diagnosed with Cystic fibrosis, on regular chest physiotherapy for at least 3 months

Exclusion criteria

Exclusion criteria: Children with history of adverse reaction to hypertonic saline or sodium bicarbonate, or history of exposure to inhaled sodium bicarbonate in preceding 3 months, or having acute severe exacerbation at the time of screening or very severe pulmonary dysfunction (FEV1 less than 30% predicted) or inability to perform spirometry or home oxygen therapy at the time of screening or within preceding 3 months.

Design outcomes

Primary

MeasureTime frame
To compare changes in pulmonary function (FEV1) following 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years.Timepoint: 3 months

Secondary

MeasureTime frame
To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on adverse effectsTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Ease of sputum expectorationTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Frequency of Pulmonary exacerbations requiring hospitalization or i/v or oral antibiotic use.Timepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Clinical severity score using Modified N. Huang Clinical Severity ScoreTimepoint: 3 months;To study the effect of 3 months of nebulization with sodium bicarbonate compared to hypertonic saline nebulization in children with cystic fibrosis age 5-18 years on Airway colonization with respiratory pathogens commonly colonizing airway in CFTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Kana Ram Jat

All Delhi

drkanaram@gmail.com9868152426

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026