A trial of position control therapy (PCT) for treatment of infantile gastro-oesophageal reflux - PCT for infants with reflux

• Conditions: gastro-oesophageal reflux related symptoms; MedDRA version: 9.1Level: LLTClassification code 10017884Term: Gastrooesophageal reflux; MedDRA version: 9.1Level: LLTClassification code 10017885Term: Gastrooesophageal reflux disease; MedDRA version: 9.1Level: LLTClassification code 10017924Term: Gastroesophageal reflux

• Registration Number: EUCTR2008-004633-24-NL
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Parental/guardian written informed consent.
•0-6 months post-natal age.
•Patients must have an observed clinical association of any two of: (1) apnoea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second feed or at least twice every 8 hrs.
•Clinical symptoms must be present for at least five days or increasing in frequency or severity over three days.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of acute life threatening events.
•Environmental exposure to cigarette smoke.
•A history or a current need for resection or reconstructive surgery of the G.I. tract or with any condition that may require surgery during the course of the study.
•Any condition that would make performance of the study procedures unsafe, or which would make it unlikely that the patient would complete the study procedures to the final day.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the effect of position control therapy on symptoms due to gastro-oesophageal reflux in infatns 0-6 months of age.;Secondary Objective: ;Primary end point(s): Questionnaire scores<br><br>Numer of GOR episodes (liquid,mixed, gas, acid(pH<4), weakly acidic (pH 4-7),weakly alkaline (pH > 7)) and their temporal association with objectively measured symptoms.