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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT06031025

Collaborator

(none)

Enrollment

Location

19.4

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Functional Gastrointestinal Disorders Gastroesophageal Reflux Constipation - Functional Diarrhea Dyschezia Colic, Infantile Vomiting; Cyclical	Other: Questionnaire, clinical examination

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 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 Design

Study Type:

Observational

Anticipated Enrollment :

71 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 20, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Prevalence and characteristics of FGID [3, 6, 12, 24 months of corrected age]
Occurrence of FGID (percentage of patients)
Prevalence and characteristics of FGID [3, 6, 12, 24 months of corrected age]
Frequency of FGID (i.e. number of symtoms per day)
Prevalence and characteristics of FGID [3, 6, 12, 24 months of corrected age]
Severity (scales from 0 to 10 for increasing values) of FGID

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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