ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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]

Comparitive Rehydration in Bronchiolitis

Secondary ID [2]

Comparitive Rehydration in Bronchiolitis

Universal Trial Number (UTN)

Trial acronym

CRIB

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bronchiolitis

Condition category

Condition code

Respiratory

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]

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]

Length of inpatient length of stay

Timepoint [1]

time till discharge in days - kept electronically and measured continuously until discharge

Secondary outcome [1]

1 To assess the duration of oxygen therapy in each group.

Timepoint [1]

time of oxygen treatment in days - recorded 3 times per day until discharge

Secondary outcome [2]

2 To assess the duration of NR and IR.

Timepoint [2]

time of non oral hydration in days - recorded 3 times per day until discharge

Secondary outcome [3]

3 To assess the length of inpatient stay in patients treated with NR and IR.

Timepoint [3]

time until discharge - recorded continuously until discharge

Secondary outcome [4]

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]

measured 3 times daily until discharge

Secondary outcome [5]

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]

measured 3 times per day until discharge

Secondary outcome [6]

6 To assess the parents satisfaction with NR and IR.

Timepoint [6]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/05/2009

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

750

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

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]

None

Name [1]

Nil

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RCH Melbourne

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ed Oakley

Address

Department of Emergrncy Medicnie monash Medical Clayton 246 Centre Road Clayton 3168

Country

Australia

Phone

+61 3 95942707

Fax

+61 3 95946564

ed.oakley@southernhealth.org.au

Contact person for scientific queries

Name

Ed Oakley

Address

Department of Emergrncy Medicnie monash Medical Clayton 246 Centre Road Clayton 3168

Country

Australia

Phone

+61 3 95942707

Fax

+61 3 95946564

ed.oakley@southernhealth.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Economic evaluation of nasogastric versus intravenous hydration in infants with bronchiolitis.	2017	https://dx.doi.org/10.1111/1742-6723.12713

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically