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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
A trial of position control therapy for
treatment of infantile gastrooesophageal
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)
Trial acronym
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Double blind randomised controlled trial. Each patient will receive one position AND one drug only.
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 998 0
Recruitment postcode(s) [2] 997 0

Funding & Sponsors
Funding source category [1] 3582 0
Government body
Name [1] 3582 0
National Health and Medical Research Council
Address [1] 3582 0
GPO Box 1421
Canberra ACT 2601
Country [1] 3582 0
Primary sponsor type
Children Women Youth Health Service
72 King William Rd
North Adelaide SA 5006
Secondary sponsor category [1] 3218 0
Name [1] 3218 0
Royal Children's Hospital
Address [1] 3218 0
Herston Road, Herston
QLD 4029
Country [1] 3218 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 5625 0
Approval date [1] 5625 0
Ethics approval number [1] 5625 0
REC 2018

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
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

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
Phone 11898 0
Fax 11898 0
Email 11898 0
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
Phone 2826 0
Fax 2826 0
Email 2826 0

No information has been provided regarding IPD availability
Summary results
No Results