Home » Trials » SLCTR/2017/017
Randomized controlled parallel arm clinical trial comparing the effectiveness, safety and cost of humidified high flow nasal cannula oxygen therapy and conventional (low flow) oxygen therapy in infants with moderate bronchiolitis
-
SLCTR Registration Number
SLCTR/2017/017
Date of Registration
The date of last modification
Mar 07, 2019
Scientific Title of Trial
Randomized controlled parallel arm clinical trial comparing the effectiveness, safety and cost of humidified high flow nasal cannula oxygen therapy and conventional (low flow) oxygen therapy in infants with moderate bronchiolitis
Public Title of Trial
Comparing the effectiveness, safety and cost of high flow oxygen and standard (low flow) oxygen in infants with bronchiolitis
Disease or Health Condition(s) Studied
Bronchiolitis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
1111-1197-5395
Any other number(s) assigned to the trial and issuing authority
J/ERC/17/79/NDR/0168 (ERC: Jaffna)
What is the research question being addressed?
What is the effectiveness, safety and cost of heated humidified high flow oxygen therapy compared to standard (low flow) oxygen therapy in infants with moderate bronchiolitis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 4
Intervention(s) planned
Study setting: Professorial Paediatric Unit, Teaching Hospital Jaffna, Sri Lanka.
Method of Randomization: Single center balanced randomized [1:1], two arm parallel group clinical trial design. A restricted (block) randomization procedure on the sample stratified by RADI score (respiratory distress assessment instrument) will be used to keep the distribution of children with low and high RADI scores similar across the two groups.
Intervention
Arm 1: The infant will receive the conventional oxygen by nasal prong 2 liters/min until the oxygen saturation is above 94% in room air (standard therapy)
Arm 2: The infant will receive heated humidified high flow oxygen (FiO2=50%) by high flow nasal cannula, at the rate of 1 liter/kg/min until oxygen the saturation is above 94% in room air.
All other standard management and supportive care such as IV fluids, antibiotics etc. will be available equally to both arms based on Unit protocols.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Need for paediatric intensive care unit (PICU) admission and intubation |
[ 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment ] |
Secondary outcome(s)
|
1.
Improvement in the heart rate, respiratory rate |
[ Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment ] |
|
2.
Improvement in respiratory distress assessment instrument (RADI) scores. |
[ Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment ] |
|
3.
Mean oxygen saturation. |
[ Assessed at: 30 minutes after intervention and then • Hourly for 2 hours • 2 hourly for 4 hours • 4 hourly until completion of 24 hours after initiation of treatment • 8 hourly until completion 48 hours after initiation of treatment ] |
|
4.
Number of hours requiring oxygen |
[ At discharge ] |
|
5.
Duration of hospital stay |
[ At discharge ] |
|
6.
Cost of the treatment (based on calculations by Senanayake et al, 2012 and Thalagala et al, 2016) |
[ At discharge ] |
|
7.
Adverse effects of humidified high flow nasal cannula oxygen |
[ Adverse effects of humidified high flow nasal cannula oxygen |
Target number/sample size
214 (107 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2017-07-01
Anticipated end date
2018-06-30
Date of first enrollment
2018-01-01
Date of study completion
Recruitment status
Recruiting
Funding source
University of Jaffna Research Grant (Ref:URG 2015)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2017-05-15
Approval number
J/ ERC/17/79/NDR/0168
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Jaffna |
| Institutional Address: | ERC Office, Faculty of Medicine, University of Jaffna, Adiyapatham Road, Kokuvil, Jaffna Sri Lanka |
| Telephone: | +94-212222073 (Extension: 342) |
| Email: | ercmedjfn@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. N. Umasankar
Lecturer
Department of Paediatrics, Faculty of Medicine, University of Jaffna,
Adiyapatham Road,
Kokuvil West, Kokuvil.
Sri Lanka
Tel: 0212220378
Mob: 0777282907
unirubaa@yahoo.com
Contact Person for Public Queries
Dr. M.G. Sathiadas
Senior Lecturer and Consultant Paediatrician
Department of Paediatrics, Faculty of Medicine, University of Jaffna,
Adiyapatham Road,
Kokuvil West, Kokuvil.
Sri Lanka
Tel: 0212220378
Mob: 0777598062
docsathiadas@hotmail.com
Primary study sponsor/organization
Department of Paediatrics Faculty of Medicine, University of Jaffna
Adiyapatham Road,
Kokuvil West, Kokuvil.
Sri Lanka
Tel : 021 222 2073
deanmedicine@jfn.ac.lk
http://www.med.jfn.ac.lk/index.php/paediatrics/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
