Clinical trial NCT06031025: Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Official title: Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Functional Gastrointestinal Disorders
Gastroesophageal Reflux
Constipation - Functional
Diarrhea
Dyschezia
Colic, Infantile
Vomiting; Cyclical
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 71
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Prevalence of FGID
timeFrame: 3, 6, 12, 24 months of corrected age
measure: Frequency of FGID
timeFrame: 3, 6, 12, 24 months of corrected age
measure: Severity of FGID
timeFrame: 3, 6, 12, 24 months of corrected age
Secondary outcomes:
measure: Somatic growth: weight
timeFrame: 3, 6, 12, 24 months of corrected age
measure: Somatic growth: head circumference
timeFrame: 3, 6, 12, 24 months of corrected age
measure: Somatic growth: length
timeFrame: 3, 6, 12, 24 months of corrected age
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Stefano Nobile, MD, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.