Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
The goal of this project is to determine the long-term health outcome of children diagnosed with gastroesophageal reflux (GER). We are inviting subjects that were previously followed in the Pediatric GI programs at Massachusetts General and Children's Hospital, Boston. We have compiled a database of more than 300 subjects that completed diagnostic testing for GER in the 1970's, 1980's, and 1990's. Subjects are being contacted initially by mail using a previously approved recruitment letter. Subjects that fail to respond to this recruitment letter are called by phone. In each case, contact information has been abstracted from the Children's Hospital database. Subjects are then given the opportunity to complete a questionnaire either by phone or in hard copy. Subjects receive no compensation for their participation in this study. Subjects will be compared to controls. Controls will complete the same questionnaire as the subjects. Inclusion of potential controls will be determined by a lack of medical history of gastroenterological diseases before the age of 21 and whether the potential control was born within a year of a subject in the study. Controls will receive $25 to participate in the study.
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||The Natural History of Children With Persistent Gastroesophageal Reflux Disease (Ages 12 to 17 Years)|
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
Subject with History of GERD
Children and adolescents ages 12-17 years, inclusive, seen at Children's Hospital, Boston or Massachusetts General Hospital between 1977 and 1990 for symptoms of GERD and also had biopsies and / or a pH probe that was positive for GERD.
Controls with out GERD
Individuals that do not have a history of GERD or other GI problems prior to age 21 and whose date of birth are with in a year of a subjects
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181805
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Harland S. Winter, MD||Massachusetts General Hospital|