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

Recruitingn/aAges 3 Months - 24 MonthsAllFondazione Policlinico Universitario Agostino Gem…
NCT06031025 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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)
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What it tests

  • Questionnaire, clinical examination
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Where

1 site
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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