Gastro-oesophageal Reflux Clinical Trial
Official title:
A Validation Study of the Dx-pH Probe in Children for the Detection of Extra-oesophageal Reflux
NCT number | NCT02457429 |
Other study ID # | R01843 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 22, 2013 |
Est. completion date | April 28, 2017 |
Verified date | January 2019 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Gastro-oesophageal reflux (GORD) and its extraoesophageal manifestations present with a
variety of symptoms in both adult and paediatric populations. In children the effects of
refluxate above the upper oesophageal sphincter (UES) has been implicated as a contributory
factor in the underlying pathological processes of a number of conditions including apnoea,
asthma, chronic cough, subglottic stenosis, chronic rhinosinusitis and otitis media. The
absence of typical symptoms in addition to the inability to obtain a formal symptom history
from a young paediatric population contributes to the difficulty in establishing a diagnosis.
At present there are no studies or data directly measuring extraoesophageal reflux and its
correlation to oesophageal pH monitoring in children.
The use of twenty-four hour oesophageal pH monitoring is regarded as the established
technique for diagnosis of GORD, however this technique has been less reliable for detecting
extra-oesophageal reflux. The investigators intend to use the Dx-pH Measurement system, a
sensitive and minimally invasive transnasal device, to assess the feasibility and validate
its use in a paediatric population.
Status | Completed |
Enrollment | 16 |
Est. completion date | April 28, 2017 |
Est. primary completion date | April 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 16 Years |
Eligibility |
Inclusion Criteria: - All children between the age of 1 year old and 16 years old consecutively referred for outpatient 24 hour oesophageal pH / impedance monitoring will be invited to participate in the study. This is regardless of the underlying diagnosis, aetiology and manifestation of symptoms. Exclusion Criteria: - Children under the age of 1 year old. Children under 1 year old will be excluded due to the technical difficulty of placing both the pH / impedance monitoring probe and the Dx-pH probe into the same nostril. Firstly, this is due to the size restriction of placing 2 probes into one nostril. Secondly, the non-pathologic high incidence of regurgitation and positing in below the age of 1 will make data difficult to interpret. - Children with an nasogastric feeding tube in situ will be excluded. Firstly due to the difficulty in placing and securing the nasogastric, oesophageal pH and Dx-pH probe (3 tubes / probes) through the nostrils, with resultant bilateral nasal obstruction. Secondly, the nasogastric tube causes increased iatrogenic reflux within the pharynx, making data more difficult to interpret and creating artificial reflux events. - Children with cleft palate prior to surgical repair will be excluded as the Dx-pH probe will be difficult to locate in the oropharynx and may displace into the oral cavity. - Children requiring pH monitoring as inpatients during an acute medical admission. Children will be excluded from the study if their condition has necessitated an acute hospital admission, therefore participation in the study will not affect other ongoing investigations, treatment or their acute condition. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Manchester Children's Hospital | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pH readings from Dx-pH measurement system | Baseline pH readings from Dx-pH measurement system. Measuring reflux events at pH <4, <4.5, <5.0 and <6.0. | 24 hours | |
Primary | pH readings from Dx-pH measurement system | Baseline pH readings from Dx-pH measurement system. Measuring events per hour at pH <4, <4.5, <5.0 and <6.0 | 24 hours | |
Primary | pH readings from Dx-pH measurement system | Baseline pH readings from Dx-pH measurement system. Measuring total reflux time at pH <4, <4.5, <5.0 and <6.0. | 24 hours | |
Primary | pH readings from Dx-pH measurement system | Baseline pH readings from Dx-pH measurement system. Measuring percentage reflux time at pH <4, <4.5, <5.0 and <6.0. | 24 hours | |
Primary | pH readings from Dx-pH measurement system | Baseline pH readings from Dx-pH measurement system. Measuring the longest reflux period at pH <4, <4.5, <5.0 and <6.0. | 24 hours | |
Secondary | Conventional oesophageal pH / impedance readings | Number of reflux events at pH <4, <4.5, <5.0, <6.0 will be measured. | 24 hours | |
Secondary | Conventional oesophageal pH / impedance readings | Number of events per hour at pH <4, <4.5, <5.0 and <6.0 will be measured. | 24 hours | |
Secondary | Conventional oesophageal pH / impedance readings | Total reflux time at pH <4, <4.5, <5.0, <6.0 will be measured. | 24 hours | |
Secondary | Conventional oesophageal pH / impedance readings | Percentage reflux time at pH <4, <4.5, <5.0, <6.0 will be measured. | 24 hours | |
Secondary | Conventional oesophageal pH / impedance readings | The longest reflux period. at pH <4, <4.5, <5.0, <6.0 will be measured. | 24 hours | |
Secondary | GORD related symptoms (GSQ-YC) | A validated 7 domain GORD symptom questionnaire (GSQ-YC) to quantify the GORD related symptoms their child suffers with. | At time of measurement | |
Secondary | Pepsin (Peptest) | A saliva sample of 0.5-1ml will then be taken for pepsin assay (Peptest). The saliva sample will be drawn into a microcentrifuge tube (0.5ml) and centrifuged. 80 microlitres is taken from the supernatant layer, vortex mixed, then applied to the assay test strip. | 15 minutes |
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