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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

22 Jun 2017

The date of last modification

Jun 22, 2017



Application Summary


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 of Health Condition(s) Studied

Bronchiolitis


Scientific Acronym

None


Public Acronym

None


Brief title

None


Universal Trail Number

1111-1197-5395


Any other number(s) assigned to the trial and issuing authority

J/ERC/17/79/NDR/0168 (ERC: Jaffna)


Trial Details


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


Assignment

Parallel


Purpose

Treatment


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

  1. Male and female infants (less than 1 year of age)
  2. Clinically diagnosed to have moderate bronchiolitis (RADI score of 4 or above)
  3. Oxygen saturation in air is less than 94%
  4. Receiving in ward treatment

Exclusion criteria

  1. Infants admitted directly to the intensive care unit (ICU)
  2. Infants with upper airway abnormalities
  3. Infants with congenital heart disease or neuromuscular anomalies
  4. Infants with diagnosed immune deficiency
  5. Infants with chronic lung disease such as bronchiolitis obliterans


Primary outcome(s)

Need for paediatric intensive care unit (PICU) admission and intubation


Primary outcome(s) - Time of assessment(s)

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

  1. Improvement in the heart rate, respiratory rate
  2. Improvement in respiratory distress assessment instrument (RADI) scores.
  3. Mean oxygen saturation.
  4. Number of hours requiring oxygen
  5. Duration of hospital stay
  6. Cost of the treatment (based on calculations by Senanayake et al, 2012 and Thalagala et al, 2016)
  7. Adverse effects of humidified high flow nasal cannula oxygen
    i. Skin irritation at the site of nasal cannula
    ii. Nasal bleeding
    iii. Abdominal/gastric distention
    iv. Feed intolerance
    v. Pneumothorax
    vi. Pneumomediastinum
    vii. Subcutaneous emphysema

Secondary outcome(s) - Time of assessment(s)

  1. Improvement in the heart rate, respiratory rate
  2. Improvement in respiratory distress assessment instrument (RADI) scores.
  3. Mean oxygen saturation.
  4. Number of hours requiring oxygen
  5. Duration of hospital stay
  6. Cost of the treatment (based on calculations by Senanayake et al, 2012 and Thalagala et al, 2016)
  7. Adverse effects of humidified high flow nasal cannula oxygen
    i. Skin irritation at the site of nasal cannula
    ii. Nasal bleeding
    iii. Abdominal/gastric distention
    iv. Feed intolerance
    v. Pneumothorax
    vi. Pneumomediastinum
    vii. Subcutaneous emphysema


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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Jaffna on 15.5.2017 (Ref: J/ ERC/17/79/NDR/0168)


Funding source

University of Jaffna Research Grant (Ref:URG 2015)



Contact & Sponsor Information


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/

Secondary study sponsor (If any)

None