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

March 10, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

71

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of FGID
Time Frame: 3, 6, 12, 24 months of corrected age
Occurrence of FGID (percentage of patients)
3, 6, 12, 24 months of corrected age
Frequency of FGID
Time Frame: 3, 6, 12, 24 months of corrected age
Frequency of FGID (i.e. number of symptoms per day)
3, 6, 12, 24 months of corrected age
Severity of FGID
Time Frame: 3, 6, 12, 24 months of corrected age
Severity (scales from 0 to 10 for increasing values) of FGID
3, 6, 12, 24 months of corrected age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Somatic growth: weight
Time Frame: 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
3, 6, 12, 24 months of corrected age
Somatic growth: head circumference
Time Frame: 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
3, 6, 12, 24 months of corrected age
Somatic growth: length
Time Frame: 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
3, 6, 12, 24 months of corrected age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Stefano Nobile, MD, PhD, MSc, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

September 30, 2025

Study Registration Dates

First Submitted

August 28, 2023

First Submitted That Met QC Criteria

September 1, 2023

First Posted (Actual)

September 11, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4921

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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