Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Sep 1, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how common certain tummy troubles, known as functional gastrointestinal disorders (FGID), are in infants who might be at higher risk. These include babies who were born prematurely or those who experienced a lack of oxygen at birth. The researchers want to find out how many of these infants have symptoms like reflux, constipation, colic, or vomiting during their first two years of life. They will also track how the babies are growing over this time.
To participate, infants must be born before 31 weeks of pregnancy or between 32 and 37 weeks with serious breathing or brain problems, or have experienced a lack of oxygen at birth. Unfortunately, babies with serious gastrointestinal diseases or whose parents do not give consent cannot join the study. If eligible, families can expect regular check-ups and questionnaires to help understand their baby's digestive health and development. This research aims to improve our understanding of these common issues in vulnerable infants, which could lead to better care in the future.
Gender
ALL
Eligibility criteria
- 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)
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Stefano Nobile, MD, PhD, MSc
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported