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
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
71 participants
May 20, 2022
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
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
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)
View Full Details on ClinicalTrials.gov
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NCT06031025