None listed
Conditions
Brief summary
The purpose of this study is to compare the efficacy of 0.9%saline and 4 ml of 0.9%saline with 2.5 mg salbutamol nebulization in infants with acute bronchiolitis. Eligible infants are randomized into group A and B. both groups will be treated with fixed regimen. Group A receive 4 ml of 0.9%saline and group B receive 4ml of 0.9%saline with salbutamol nebulization at 6 hours’ interval. Hypothesis are; 1.there is no difference between 0.9%saline alone and in combination with salbutamol in reducing hospital stay in infants with acute bronchiolitis. 2. 0.9%saline nebulization is more effective and safe alone than in combination with salbutamol in infants with acute bronchiolitis. Condition or Disease Intervention/Treatment Phase Acute bronchiolitis Drug: 0.9% saline Drug: salbutamol Procedure: nebulization Not applicable Detail description: This double blind randomize control trail will be conducted in the department of pediatrics, Lady Reading Hospital MTI/LRH Peshawar after the approval of the hospital ethical committee. Eligible infants will be included in this study and informed consent will be taken from the parents. Clinical severity score will be assessed by using Wang et al score. Investigators will examine in the infants at the time admission and 12 hourly after treatment.
Interventions
Experimental: Group A – 4ml of 0.9% saline nebulization supervised by a train doctor, at 4 hour interval for a maximum 12 hours duration though a conventional nebulizer with a face tight mask attached to oxygen source with the flow rate of 5L/min. infants will assessed by investigators before and after intervention at 12 hour intervals. Wang et al clinical severity scale will be used for assessing the severity. Length of hospital stay will be measured from admission till the patient is ready to
Experimental: Group A – 4ml of 0.9% saline nebulization supervised by a train doctor, at 4 hour interval for a maximum 12 hours duration though a conventional nebulizer with a face tight mask attached to oxygen source with the flow rate of 5L/min. infants will assessed by investigators before and after intervention at 12 hour intervals. Wang et al clinical severity scale will be used for assessing the severity. Length of hospital stay will be measured from admission till the patient is ready to discharge (clinical severity score <3) Drug A: 4ml of 0.9% saline Other name: normal saline Procedure: nebulization Device: conventional nebulizer
Sponsors
Dr Amir Muhammad
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
1.infant 1month to 2 years age 2.both male and female 3.clinical severity score between 1 and 9 4.first episode of bronchiolitis
Exclusion criteria
1.prematurity 2.any underlying disease eg cystic fibrosis, cardiac or renal disease. 3.prior history of wheezing 4.asthma, allergic rhinitis, progressive respiratory failure 5.clinical severity score>9.
Outcome results
None listed