RecruitingNCT06031025

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

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

71 participants

Start Date

May 20, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 3 MonthsMax Age: 24 Months

Inclusion Criteria3

  • 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 Criteria2

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

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Interventions

OTHERQuestionnaire, clinical examination

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.


Locations(1)

Fondazione Policlinico Gemelli IRCCS

Roma, Italy

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NCT06031025


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