Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000988257
Ethics application status
Approved
Date submitted
10/07/2008
Date registered
17/11/2009
Date last updated
17/11/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of position control therapy for
treatment of infantile gastrooesophageal
reflux.
Scientific title
A trial to investigate the effects of position control therapy on gastrooesophageal reflux episodes and gastric emptying in infants with gastrooesophageal reflux disease
Universal Trial Number (UTN)
U1111-1111-9553
Trial acronym
PCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infantile gastrooesophageal
reflux (GOR) disease 3399 0
Condition category
Condition code
Oral and Gastrointestinal 3544 3544 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants will be randomised to either a side position applied by specially desighned cushions or an elevation of the head of the cot. Positioning will be applied every day for the total of 14 treatment days.
Intervention code [1] 3123 0
Treatment: Other
Intervention code [2] 241319 0
Treatment: Drugs
Comparator / control treatment
Infants will be also be randomised to either a conventional drug reflux treatment (omeprazole 1mg/kg, oral solution) or placebo (Mylanta 1mg/kg, oral solutuion). Therapy will be given every day for the total of 14 treatment days in conjuction with positioning (see above).
Control group
Placebo

Outcomes
Primary outcome [1] 4446 0
Number of GOR episodes as recorded by 24h ph/impadance.
Timepoint [1] 4446 0
14 days after randomisation
Secondary outcome [1] 7518 0
the gastric emptying rate will be asessed using the 13-C octanoate breath test.
Timepoint [1] 7518 0
14 days after randomisation

Eligibility
Key inclusion criteria
Symptoms considered to be related to GOR such as crying, irritablility, feed refusal, vomiting/spilling, gagging.
Minimum age
0 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of acute life threatening events or resectional surgery of the gastrointestinal tract or any condition that may require surgery during the length of the study, environmental exposure to cigarette smoke

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)
Patient will be rectruited by a study nurse. A trail investigator will determine if patient is eligible to be randomised after analysis of baseline study results. Position therapy will be assigned by study nurse after opening sealed opaque envelopes and drug therapy will be assigned by hospital pharamcist according to randomisation plan.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation computer programme
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Double blind randomised controlled trial. Each patient will receive one position AND one drug only.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/07/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 997 0
5000
Recruitment postcode(s) [2] 998 0
4029

Funding & Sponsors
Funding source category [1] 3582 0
Government body
Name [1] 3582 0
National Health and Medical Research Council
Country [1] 3582 0
Australia
Primary sponsor type
Hospital
Name
Children Women Youth Health Service
Address
72 King William Rd
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 3218 0
Hospital
Name [1] 3218 0
Royal Children's Hospital
Address [1] 3218 0
Herston Road, Herston
QLD 4029
Country [1] 3218 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5625 0
Women's & Children's Hospital Research Ethics
Ethics committee address [1] 5625 0
Children's Youth & Women's Health Service
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 5625 0
Australia
Date submitted for ethics approval [1] 5625 0
Approval date [1] 5625 0
16/01/2008
Ethics approval number [1] 5625 0
REC 2018

Summary
Brief summary
Gastro-oesophageal reflux (GOR) is a very common condition that interrupts
feeding and sleep routine in up to 30% of newborn infants. GOR disease affects
3-5% of newborns and is defined when more serious complications are associated
with GOR. Typical GOR disease symptoms include vomiting, failure to thrive, pain,
irritability/crying/back-arching), oesophagitis and respiratory disorders
(apnoea/coughing). The diagnosis and treatment of GOR disease in infants is
fraught with difficulty due to the wide range of clinical presentations and the lack of
diagnostic modalities and appropriate diagnostic criteria. These issues lead to
failure to accurately diagnose reflux disease, allowing more severe problems to
manifest, or alternatively, over-diagnosis of reflux disease leading to the
prescription of unnecessary and costly acid suppression therapies and surgical
interventions.
This research project will evaluate positioning as a simple,
non-pharmacological approach to the treatment of GOR related symptoms in
infants 0-6months of age. We believe that position control therapy (PCT) is simple for parents to perform and can be safely combined with pharmacological therapy for added efficacy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28741 0
Address 28741 0
Country 28741 0
Phone 28741 0
Fax 28741 0
Email 28741 0
Contact person for public queries
Name 11898 0
Dr Taher Omari
Address 11898 0
Gastroenterology Unit, CYWHS
72 King William Rd, North Adelaide SA 5006
Country 11898 0
Australia
Phone 11898 0
+61881616880
Fax 11898 0
+61881616088
Email 11898 0
[email protected]
Contact person for scientific queries
Name 2826 0
Dr Taher Omari
Address 2826 0
Gastroenterology Unit, CYWHS
72 King William Rd, North Adelaide SA 5006
Country 2826 0
Australia
Phone 2826 0
+61881616880
Fax 2826 0
+61881616088
Email 2826 0
[email protected]

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
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Documents added automatically
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