← Back to Clinical Trials
Recruiting NCT06031025

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

Trial Parameters

Condition Functional Gastrointestinal Disorders
Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Type OBSERVATIONAL
Phase N/A
Enrollment 71
Sex ALL
Min Age 3 Months
Max Age 24 Months
Start Date 2022-05-20
Completion 2025-09-30
Interventions
Questionnaire, clinical examination

Brief 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.

Eligibility Criteria

Inclusion Criteria: * infants with gestational age at birth \< 31 weeks * infants with gestational age at birth \< 37 weeks and major respiratory or neurologic morbidity * infants with history of perinatal asphyxia Exclusion Criteria: * lack of informed consent * diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)

Related Trials