RecruitingPhase 3ACTRN12609000988257

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


Sponsor

Children Women Youth Health Service

Enrollment

200 participants

Start Date

Jul 12, 2008

Study Type

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

Sex: Both males and femalesMin Age: 0 MonthssMax Age: 6 Monthss

Plain Language Summary

Simplified for easier understanding

This study is testing whether positioning (holding or placing babies in certain ways) can reduce the symptoms of gastro-oesophageal reflux (GOR) — where stomach contents come back up into the food pipe — in babies aged 0 to 6 months. Reflux is very common in babies and can cause pain, vomiting, irritability, and feeding difficulties. Position control therapy is a simple, drug-free approach that parents can do at home, and researchers want to see if it works on its own or in combination with medicines. You may be eligible if: - Your baby is between 0 and 6 months old - Your baby has symptoms likely related to reflux, such as crying, irritability, feed refusal, vomiting, or gagging You may NOT be eligible if: - Your baby has had a life-threatening event (such as stopping breathing) - Your baby has had surgery on the digestive system or may need surgery during the study - Your baby is exposed to cigarette smoke at home Talk to your doctor about whether this trial might be right for you.

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

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)

Australia

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ACTRN12609000988257