Viewing Study NCT00311233



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Last Modification Date: 2024-10-26 @ 9:24 AM
Study NCT ID: NCT00311233
Status: COMPLETED
Last Update Posted: 2008-05-23
First Post: 2006-04-03

Brief Title: Recurrent Abdominal Pain in Childhood -Characteristics and Course
Sponsor: Sykehuset Innlandet HF
Organization: Sykehuset Innlandet HF

Study Overview

Official Title: Recurrent Abdominal Pain in Childhood Characteristics and Course
Status: COMPLETED
Status Verified Date: 2008-05
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: Recurrent abdominal pain RAP is a common complaint in childhood Identification of the processes that maintain illness is important

The purpose of this study is to get more knowledge about characteristics of children with recurrent abdominal pain and their parents and about the course of their pain These results may be important to identify children who need treatment
Detailed Description: BACKGROUND

Recurrent abdominal pain RAP mainly constituted by functional gastrointestinal disorders FGID affects a significant number of children and is a result of a complex interaction between biopsychosocial factors Despite the seemingly benign nature of RAP in some children RAP is associated with school absenteeism functional impairment and frequent doctor visits Identification of the processes that maintain illness is important These results may be important to identify children who need treatment

AIMS

The aims of this study are to characterize children with RAP in four out-patient clinics and their parents describe outcome and determine predictors of persistent RAP in children

SAMPLE

150 pediatric patients 4-15 years their parents and teachers Consecutive new patients referred to four pediatric out-patients clinics for evaluation of abdominal pain primary complaint Patients with RAP abdominal pain at least once a month in three consecutive months during the last year and whose pains are severe enough to affect daily activity are eligible

DESIGN A prospective cohort study

MEASUREMENT

All pediatric patients will undergo a complete physical examination emphasizing diagnosing organic illness and FGID according to the international ROME classification Routine laboratory will be done A protocol to identify somatic causes is part of the study In addition parents will complete validated questionnaires regarding their childs physicalpsychological health temperamental characteristics and social skills and also psychosocial conditions concerning them selves Self-report regarding the same aspects will be obtained from children above 8-9 years

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