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

Diarrhea Clinical Trial

— FUSID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06031025
• Other study ID #: 4921
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Nobile, MD, PhD, MSc
• Phone: +390630156937
• Email: stefano.nobile[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 24 Months

Eligibility

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)

Related Conditions & MeSH terms

• Colic
• Colic, Infantile
• Constipation
• Constipation - Functional
• Diarrhea
• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastroesophageal Reflux
• Gastrointestinal Diseases
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. D — View 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: 1 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of FGID	Occurrence of FGID (percentage of patients)	3, 6, 12, 24 months of corrected age
Primary	Frequency of FGID	Frequency of FGID (i.e. number of symptoms per day)	3, 6, 12, 24 months of corrected age
Primary	Severity of FGID	Severity (scales from 0 to 10 for increasing values) of FGID	3, 6, 12, 24 months of corrected age
Secondary	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
Secondary	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
Secondary	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