Understanding gastrointestinal disorders in at-risk infants
Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
This study looks at how common gut problems are in at-risk infants, like those born early or who had trouble at birth, to see how these issues affect their growth and health in the first two years of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 71 (estimated) |
| Ages | 3 Months to 24 Months |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06031025 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at-risk infants, specifically those who are former preterm infants or have experienced birth asphyxia, during their first two years of life. Participants will undergo clinical assessments and complete structured questionnaires based on the Rome IV criteria at various intervals (3, 6, 12, and 24 months). The study will evaluate symptoms related to gastroesophageal reflux and other FGID, while also monitoring growth parameters using WHO standards. Data collected will be analyzed statistically to compare findings with existing literature on term infants.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 31 weeks of gestation or those born before 37 weeks with significant respiratory or neurological issues, as well as infants with a history of perinatal asphyxia.
Not a fit: Patients with congenital or major gastrointestinal diseases, such as inflammatory bowel disease or cancer, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of FGID in at-risk infants, leading to better diagnosis and management strategies.
How similar studies have performed: While this study focuses on a specific at-risk population, similar studies on FGID in infants have shown varying degrees of success, indicating a need for further exploration in this area.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Roma
- Fondazione Policlinico Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Principal investigator: Stefano Nobile, MD, PhD, MSc — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Stefano Nobile, MD, PhD, MSc
- Email: stefano.nobile@policlinicogemelli.it
- Phone: +390630156937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.