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NIVA

A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL EVALUATING NON INVASIVE VENTILATION ACUTE EXACERBATION OF CHILDHOOD BRONCHIAL ASTHMA - NIVA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/019079
Enrollment
90
Registered
2019-05-13
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: J980- Diseases of bronchus, not elsewhere classified

Interventions

Intervention1: GROUP A: Bilevel positive airway pressure delivering peak inspiratory pressure of 15cm of H2O, peak end expiratory pressure of 5cm of H2O by face mask with rate dependent on age, oxygen

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CHILDREN PRESENTING TO THE PEDIATRICS EMERGENCY OR OUT PATIENT DEPARTMENT WITH ACUTE EXACERBATION DEFINED AS TACHYPNEA,HISTORY OF PREVIOUS SIMILAR EPISODES AND WHEEZING

Exclusion criteria

Exclusion criteria: 1.Children presenting with respiratory failure requiring immediate endotracheal intubation and assisted ventilation 2.Children with physician diagnosed bronchiolitis defined as the coryzal prodrome lasting 1 to 3 days followed by the persistence of cough and either tachypnea/chest recession and either wheeze/crackles on auscultation 3.Clinical suspicion of bacterial pneumonia:focal crackles or bronchial breathing and/or major chest x ray finding [consolidation,major infiltrates,pleural effusion] 4.Any contraindication to NIV use including altered mental status, recent bowel surgery,intractable vomiting,inability to protect airway 5.Current tracheostomy,home ventilation[IPPV or NIPPV]or home oxygen requirement 6.Receiving maintenance dose of oral steroid at time of hospital admission 7.History of congenital heart disease or chronic heart disease [including bronchopulmonary dysplasia,cystic fibrosis,pulmonary hypertension] 8.Craniofacial abnormality 9.pneumothorax at present

Design outcomes

Primary

MeasureTime frame
Length of the time to reach pram score less than 3Timepoint: Assessment every hourly till pram score is less then 3

Secondary

MeasureTime frame
1.Length of time to achieve hospital discharge criteria 2.Time to room air respiration 3.Comparison of bronchodilator requirement between groups [ median number of intravenous infusion hours,total salbutamol doses per patient per admission ,median doses of salbutamol per day] 4.Each group that require intubation and invasive ventilation 5.Each group experiencing significant treatment related side effects 6.Each group requiring hospital readmission within 48 hours of dischargeTimepoint: Assessment every hourly

Countries

India

Contacts

Public ContactTARUN AHUJA

PGIMER

dr.joseph.l.mathew@gmail.com8264400604

Outcome results

None listed

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