A trial of position control therapy for treatment of infantile gastrooesophageal reflux.
A trial to investigate the effects of position control therapy on gastrooesophageal reflux episodes and gastric emptying in infants with gastrooesophageal reflux disease
Children Women Youth Health Service
200 participants
Jul 12, 2008
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
Locations(1)
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ACTRN12609000988257