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Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants. — FUSID  

Diarrhea Clinical Trial

Official title:
Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants

Clinical Trial Summary

The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are: - evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life - describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.

Clinical Trial Description

Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic. Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed. Z-scores for weight, length and head circumference will be calculated according to the World Health Organization (WHO) standards. Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods. The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06031025
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Stefano Nobile, MD, PhD, MSc
Phone +390630156937
Email stefano.nobile@policlinicogemelli.it
Status Recruiting
Phase
Start date May 20, 2022
Completion date December 31, 2024
View Details
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