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RECRUITING
NCT06031025

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

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

3 Months - 24 Months

Study Type

OBSERVATIONAL

Enrollment

71

Start Date

2022-05-20

Completion Date

2025-09-30

Last Updated

2025-03-11

Healthy Volunteers

No

Interventions

OTHER

Questionnaire, clinical examination

At each follow up visit, a clinical examination and anthropometric evaluation will be performed. Parents will fill a structured questionnaire to describe the occurrence and characteristics of functional gastrointestinal disorders.

Locations (1)

Fondazione Policlinico Gemelli IRCCS

Roma, Italy