About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
lack of informed consent
diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)
Trial population
Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).
Trial design
Cohort
Prospective
Treatments tested in this trial
Questionnaire, clinical examination
Other interventionAt 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.
Treatment groups
Trial outcomes
Primary outcomes
Prevalence of FGID
Occurrence of FGID (percentage of patients)
Frequency of FGID
Frequency of FGID (i.e. number of symptoms per day)
Severity of FGID
Severity (scales from 0 to 10 for increasing values) of FGID
Secondary outcomes
Somatic growth: weight
Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization
Somatic growth: head circumference
Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization
Somatic growth: length
Measurement of length and calculation of z-scores based on reference standards by the World Health Organization
Sponsors and contacts
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