Understanding gastrointestinal disorders in at-risk infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.