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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000988257

Acronym

PCT

Enrollment

200

Registered

2009-11-17

Start date

2008-07-12

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 6 Months

Healthy volunteers

Inclusion criteria

Symptoms considered to be related to GOR such as crying, irritablility, feed refusal, vomiting/spilling, gagging.

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

Outcome results