Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.

Study Overview
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Brief Summary
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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 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.

Detailed Description
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Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local Follow-up clinic. Clinical examination, anthropometric measurement and data from a structured questionnaire to detect FGID will be performed. Z-scores for weight, length and head circumference will be calculated according to the WHO standards. Data from the questionnaires will be collected. Clinical characteristics of patients and perinatal data will be collected and analyzed by appropriate statistical methods. The prevalence and characteristics of FGID in the study population will be compared to published data (mostly from term infants).

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

Conditions
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Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Constipation - Functional, Diarrhea, Dyschezia, Colic, Infantile, Vomiting; Cyclical

Intervention / Treatment
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* Other: Questionnaire, clinical examination


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire, clinical examination|At 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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and characteristics of FGID | Occurrence of FGID (percentage of patients) | 3, 6, 12, 24 months of corrected age | 
| Prevalence and characteristics of FGID | Frequency of FGID (i.e. number of symtoms per day) | 3, 6, 12, 24 months of corrected age | 
| Prevalence and characteristics of FGID | Severity (scales from 0 to 10 for increasing values) of FGID | 3, 6, 12, 24 months of corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Somatic growth: weight | Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization | 3, 6, 12, 24 months of corrected age | 
| Somatic growth: head circumference | Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization | 3, 6, 12, 24 months of corrected age | 
| Somatic growth: length | Measurement of length and calculation of z-scores based on reference standards by the World Health Organization | 3, 6, 12, 24 months of corrected age |