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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 2
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Fondazione Policlinico Gemelli IRCCS
RECRUITING
Roma
Contact Information
Primary
Stefano Nobile, MD, PhD, MSc
stefano.nobile@policlinicogemelli.it
+390630156937
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 71
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov