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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:
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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire, clinical examination | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of FGID | Occurrence of FGID (percentage of patients) | 3, 6, 12, 24 months of corrected age |
| Frequency of FGID | Frequency of FGID (i.e. number of symptoms per day) | 3, 6, 12, 24 months of corrected age |
| Severity of FGID | Severity (scales from 0 to 10 for increasing values) of FGID | 3, 6, 12, 24 months of corrected age |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefano Nobile, MD, PhD, MSc | Contact | +390630156937 | stefano.nobile@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Stefano Nobile, MD, PhD, MSc | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32446468 | Result | Steutel NF, Zeevenhooven J, Scarpato E, Vandenplas Y, Tabbers MM, Staiano A, Benninga MA. Prevalence of Functional Gastrointestinal Disorders in European Infants and Toddlers. J Pediatr. 2020 Jun;221:107-114. doi: 10.1016/j.jpeds.2020.02.076. | |
| 29398057 | Result | Robin SG, Keller C, Zwiener R, Hyman PE, Nurko S, Saps M, Di Lorenzo C, Shulman RJ, Hyams JS, Palsson O, van Tilburg MAL. Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the Rome IV Criteria. J Pediatr. 2018 Apr;195:134-139. doi: 10.1016/j.jpeds.2017.12.012. Epub 2018 Feb 3. |
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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 |
| 27144631 | Result | Benninga MA, Faure C, Hyman PE, St James Roberts I, Schechter NL, Nurko S. Childhood Functional Gastrointestinal Disorders: Neonate/Toddler. Gastroenterology. 2016 Feb 15:S0016-5085(16)00182-7. doi: 10.1053/j.gastro.2016.02.016. Online ahead of print. |
| 15893282 | Result | Iacono G, Merolla R, D'Amico D, Bonci E, Cavataio F, Di Prima L, Scalici C, Indinnimeo L, Averna MR, Carroccio A; Paediatric Study Group on Gastrointestinal Symptoms in Infancy. Gastrointestinal symptoms in infancy: a population-based prospective study. Dig Liver Dis. 2005 Jun;37(6):432-8. doi: 10.1016/j.dld.2005.01.009. Epub 2005 Mar 2. |
| 36705695 | Result | Scarpato E, Salvatore S, Romano C, Bruzzese D, Ferrara D, Inferrera R, Zeevenhooven J, Steutel NF, Benninga MA, Staiano A. Prevalence and Risk Factors of Functional Gastrointestinal Disorders: A Cross-Sectional Study in Italian Infants and Young Children. J Pediatr Gastroenterol Nutr. 2023 Feb 1;76(2):e27-e35. doi: 10.1097/MPG.0000000000003653. Epub 2022 Nov 1. |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D005764 | Gastroesophageal Reflux |
| D003967 | Diarrhea |
| D003248 | Constipation |
| D003085 | Colic |
| C536228 | Familial cyclic vomiting syndrome |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
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