Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Prevalence of FGID — 3, 6, 12, 24 months of corrected age
Occurrence of FGID (percentage of patients) - Frequency of FGID — 3, 6, 12, 24 months of corrected age
Frequency of FGID (i.e. number of symptoms per day) - Severity of FGID — 3, 6, 12, 24 months of corrected age
Severity (scales from 0 to 10 for increasing values) of FGID
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Roma | Italy | Recruiting |
More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06031025 on ClinicalTrials.gov ↗ ← All trials in Italy