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

Recruiting

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

• Registration Number: NCT06031025
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

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).

Study Timeline

• Study Start: 2022-05-20
• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 71

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Somatic growth: weight	3, 6, 12, 24 months of corrected age	Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization
Somatic growth: head circumference	3, 6, 12, 24 months of corrected age	Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization
Somatic growth: length	3, 6, 12, 24 months of corrected age	Measurement of length and calculation of z-scores based on reference standards by the World Health Organization

Trial Locations

Locations (1)

Fondazione Policlinico Gemelli IRCCS; 🇮🇹 Roma, Italy