Trial registered on ANZCTR


Trial ID
ACTRN12605000033640
Ethics application status
Approved
Date submitted
19/07/2005
Date registered
22/07/2005
Date last updated
3/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparitive Rehydration in Bronchiolitis
Scientific title
A prospective randomized trial comparing nasogastric with intravenous rehydration in children with bronchiolitis
Secondary ID [1] 912 0
Comparitive Rehydration in Bronchiolitis
Secondary ID [2] 913 0
Comparitive Rehydration in Bronchiolitis
Universal Trial Number (UTN)
Trial acronym
CRIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 96 0
Condition category
Condition code
Respiratory 117 117 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Open randomised trial comparing nasogastric and intravenous hydration in children under 1 year of age with bronchiolitis.
Intervention code [1] 40 0
Treatment: Other
Comparator / control treatment
intravenous versus nasogastric route for hydration. each intervention is a one off, for fluid administration. Intravenous drip (IV) insertion is using topical anaesthesia and site is at the discretion of the clinician. Nasogastric insertion is using topical anaesthetic sprar and in either nostril. Standardised means of determining insertion are used. Fluid administration is 80% maintnance with 0.9% sodium chloride with 5% dextrose in the IV goup and oral rehydration solution for the first 2 hours then usual feed for the nasogastric group
Control group
Active

Outcomes
Primary outcome [1] 147 0
Length of inpatient length of stay
Timepoint [1] 147 0
time till discharge in days - kept electronically and measured continuously until discharge
Secondary outcome [1] 322 0
1 To assess the duration of oxygen therapy in each group.
Timepoint [1] 322 0
time of oxygen treatment in days - recorded 3 times per day until discharge
Secondary outcome [2] 323 0
2 To assess the duration of NR and IR.
Timepoint [2] 323 0
time of non oral hydration in days - recorded 3 times per day until discharge
Secondary outcome [3] 324 0
3 To assess the length of inpatient stay in patients treated with NR and IR.
Timepoint [3] 324 0
time until discharge - recorded continuously until discharge
Secondary outcome [4] 325 0
4 To document the incidence of patient deterioration with different hydration strategies in bronchiolitis, defined by forced change from NR to IR, need of ventilatory support, and ICU admission.
Timepoint [4] 325 0
measured 3 times daily until discharge
Secondary outcome [5] 326 0
5 To document the incidence of complications of rehydration therapy (e.g. electrolyte abnormalities, iv line/NGT needing replacement because of blockage or loss, iv tissuing, aspiration).
Timepoint [5] 326 0
measured 3 times per day until discharge
Secondary outcome [6] 327 0
6 To assess the parents satisfaction with NR and IR.
Timepoint [6] 327 0
Daily during inpatient stay, and at time of discharge

Eligibility
Key inclusion criteria
1 Age more than 8 weeks (corrected for prematurity) and less than 12 months. 2 With symptoms of bronchiolitis as defined by respiratory distress (tachypnoea, recessions, nasal flaring etc.) due to acute viral respiratory tract infection. 3 Requiring hydration.
Minimum age
8 Weeks
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 Chronic respiratory disease. 2 Choanal atresia. 3 Severe dehydration (needing iv resuscitation). 4 Need of immediate ventilatory support. 5 Increased respiratory effort (severe recessions) and hypoxaemia (SaO2 <90% in >30% FiO2, or >2l/min O2). 6 Reasons for needing iv access other than bronchiolitis (investigations, medication).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelope opened after consent at time of institution of hydration. Sequence concealed until randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random block assignment
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 162 0
Government body
Name [1] 162 0
NHMRC
Address [1] 162 0
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 162 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
16 Marcus Clarke Street
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 117 0
None
Name [1] 117 0
Nil
Address [1] 117 0
Country [1] 117 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 907 0
RCH Melbourne
Ethics committee address [1] 907 0
Ethics committee country [1] 907 0
Australia
Date submitted for ethics approval [1] 907 0
Approval date [1] 907 0
Ethics approval number [1] 907 0

Summary
Brief summary
The need for supplying fluids in paediatric bronchiolitis (severe viral airway infection of the infant) is frequent, and is the consequence of reduced feeding, sweating, and fever., There are currently 2 means of supplying fluids, intravenous or nasogastric.

Nasogastric rehydration (NR) means giving fluids through a feeding tube inserted through the nostrils into the stomach thus eliminating the effort of drinking. It is generally effective and has few complications.
Intra venous rehydration (IR) means giving fluids directly into a vein through a drip. It is often difficult to insert a drip in this particular age group, whereas the nasal feeding tube is generally easier to insert.

The potential complications of IR are water overload and electrolyte imbalances. The main possible complications of NR is vomiting.
The role of NR in bronchiolitis is, however, controversial. It is, for example, an accepted treatment in Scandinavia and Switzerland, whereas IR is the accepted treatment at the RCH Melbourne. Even within Australia there is no standard of care as such among the different hospitals with most hospitals using a combination of NR and IR, without any guidelines. The little existing evidence shows that NR in bronchiolitis is safe and well tolerated.

The major concern raised with NR is the partial obstruction of the airway, by cousing ablockage of the nostril in young children who mostly breathe through the nose, thus theoretically causing further breathing problems. But its clinical significance, especially in bronchiolitis, is not clear and has not been the subject of clinical trials.

In this prospective study we will compare Nasogastric and Intravenous treatment in bronchiolitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35645 0
Address 35645 0
Country 35645 0
Phone 35645 0
Fax 35645 0
Email 35645 0
Contact person for public queries
Name 9229 0
Ed Oakley
Address 9229 0
Department of Emergrncy Medicnie monash Medical Clayton 246 Centre Road Clayton 3168
Country 9229 0
Australia
Phone 9229 0
+61 3 95942707
Fax 9229 0
+61 3 95946564
Email 9229 0
ed.oakley@southernhealth.org.au
Contact person for scientific queries
Name 157 0
Ed Oakley
Address 157 0
Department of Emergrncy Medicnie monash Medical Clayton 246 Centre Road Clayton 3168
Country 157 0
Australia
Phone 157 0
+61 3 95942707
Fax 157 0
+61 3 95946564
Email 157 0
ed.oakley@southernhealth.org.au