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NCT Number: NCT06031025

Prevalence and Natural History of Functional Gastrointestinal 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.

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Key information

Conditions

Functional Gastrointestinal Disorders Colic Colic, Infantile Congenital, Hereditary, and Neonatal Diseases and Abnormalities Constipation Constipation - Functional Deglutition Disorders Diarrhea Digestive System Diseases Dyschezia Esophageal Diseases Esophageal Motility Disorders Familial cyclic vomiting syndrome Gastroesophageal Reflux Gastrointestinal Diseases Infant, Newborn, Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting; Cyclical

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione Policlinico Gemelli IRCCS

Roma, 00168, Italy

Location status: Recruiting

Location contact

Stefano Nobile, MD, PhD, MSc

CONTACT

[email protected]

+390630156937

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire, clinical examination

Other

At each follow up visit, a clinical examination and anthropometric evaluation will be performed. Parents will fill a structured questionnaire to describe the occurrence and characteristics of functional gastrointestinal disorders.

Primary outcomes

  1. Prevalence of FGID

    Time frame: 3, 6, 12, 24 months of corrected age

    Occurrence of FGID (percentage of patients)

  2. Frequency of FGID

    Time frame: 3, 6, 12, 24 months of corrected age

    Frequency of FGID (i.e. number of symptoms per day)

  3. Severity of FGID

    Time frame: 3, 6, 12, 24 months of corrected age

    Severity (scales from 0 to 10 for increasing values) of FGID

Secondary outcomes

  1. 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

  2. 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. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Stefano Nobile, MD, PhD, MSc

CONTACT

[email protected]

+390630156937

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: FUSID

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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