Colic, Infantile, Constipation - Functional, Diarrhea, Dyschezia, Functional Gastrointestinal Disorders, Gastroesophageal Reflux, Vomiting; Cyclical
Conditions
Brief summary
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.
Detailed description
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 World Health Organization (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).
Interventions
OTHERQuestionnaire, 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.
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 24 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of FGID | 3, 6, 12, 24 months of corrected age | Occurrence of FGID (percentage of patients) |
| Frequency of FGID | 3, 6, 12, 24 months of corrected age | Frequency of FGID (i.e. number of symptoms per day) |
| Severity of FGID | 3, 6, 12, 24 months of corrected age | Severity (scales from 0 to 10 for increasing values) of FGID |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Somatic growth: weight | 3, 6, 12, 24 months of corrected age | Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization |
| Somatic growth: head circumference | 3, 6, 12, 24 months of corrected age | Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization |
| Somatic growth: length | 3, 6, 12, 24 months of corrected age | Measurement of length and calculation of z-scores based on reference standards by the World Health Organization |
Countries
Italy
Contacts
Primary ContactStefano Nobile, MD, PhD, MSc
Outcome results
None listed