Status:

RECRUITING

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

Lead Sponsor:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Conditions:

Functional Gastrointestinal Disorders

Gastroesophageal Reflux

Eligibility:

All Genders

3-24 years

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 birt...

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...

Eligibility Criteria

Inclusion

  • 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

  • lack of informed consent
  • diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)

Key Trial Info

Start Date :

May 20 2022

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 30 2025

Estimated Enrollment :

71 Patients enrolled

Trial Details

Trial ID

NCT06031025

Start Date

May 20 2022

End Date

September 30 2025

Last Update

March 11 2025

Active Locations (1)

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Fondazione Policlinico Gemelli IRCCS

Roma, Italy, 00168