NCT06031025

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 71 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Functional Gastrointestinal Disorders
• Gastroesophageal Reflux
• Constipation - Functional
• Diarrhea
• Dyschezia
• Colic, Infantile
• Vomiting; Cyclical

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-20
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2023-09-11
• Last updated: 2025-03-11

Locations

1 site across 1 country: Italy