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

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

Recruiting
3-24 years
All
Phase N/A

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Overview

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 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.

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 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).

Eligibility

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

NCT06031025

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

14 October 2025

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