Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512382
Status:
COMPLETED
Last Update Posted:
2011-09-07
First Post:
2007-08-06
Brief Title:
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat WheezingCoughing Babies
Sponsor:
Wolfson Medical Center
Organization:
Wolfson Medical Center
Study Overview
Official Title:
The Nature of Reflux-respiratory Symptoms Association in Difficult to Treat AsthmaticWheezing Babies Using Impedance and Wheezy Monitoring
Status:
COMPLETED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
GER and respiratory symptoms are both common phenomenon in children Both can coexist in the same patient by chance alone Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality Therefore we conducted an observational study To determine the primary cause RS or GERusing for the first time both PH-Impedance as measurements of GER and Wheezy monitoring WEEM that records simultaneously wheeze and cough noises Both modalities will be recorded for 12-24 hours If GER precedes coughwheeze recordings it points to GER being the possible precipitating factor and vice versa
Detailed Description:
GER and respiratory symptoms are both common phenomenon in children Both can coexist in the same patient by chance alone Research reveals increased incidence for both to coexist leading to suspect a temporal association and possible causality Therefore we conducted an observational study To determine the primary cause RS or GERusing for the first time both PH-Impedance as measurements of GER and Wheezy monitoring WEEM that records simultaneously wheeze and cough noises Both modalities will be recorded for 12-24 hours If GER precedes coughwheeze recordings it points to GER being the possible precipitating factorHowever If coughwheeze precedes GER recordings it points to coughwheeze being the possible precipitating factor The recordings will be investigated 1 minute before and one minute after each event
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None