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

Last updated: March 10, 2025
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Colic

Vomiting

Treatment

Questionnaire, clinical examination

Clinical Study ID

NCT06031025
4921
  • Ages 3-24
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • infants with gestational age at birth < 31 weeks

  • infants with gestational age at birth < 37 weeks and major respiratory or neurologicmorbidity

  • infants with history of perinatal asphyxia

Exclusion

Exclusion Criteria:

  • lack of informed consent

  • diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatorybowel disease, cancer)

Study Design

Total Participants: 71
Treatment Group(s): 1
Primary Treatment: Questionnaire, clinical examination
Phase:
Study Start date:
May 20, 2022
Estimated Completion Date:
September 30, 2025

Study 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).

Connect with a study center

  • Fondazione Policlinico Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

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