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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-24
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

lack of informed consent

diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)

Trial population

Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as per clinical routine of the local Institution).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire, clinical examination

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Prevalence of FGID

Occurrence of FGID (percentage of patients)

Time frame
3, 6, 12, 24 months of corrected age
2

Frequency of FGID

Frequency of FGID (i.e. number of symptoms per day)

Time frame
3, 6, 12, 24 months of corrected age
3

Severity of FGID

Severity (scales from 0 to 10 for increasing values) of FGID

Time frame
3, 6, 12, 24 months of corrected age

Secondary outcomes

1

Somatic growth: weight

Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization

Time frame
3, 6, 12, 24 months of corrected age
2

Somatic growth: head circumference

Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization

Time frame
3, 6, 12, 24 months of corrected age
3

Somatic growth: length

Measurement of length and calculation of z-scores based on reference standards by the World Health Organization

Time frame
3, 6, 12, 24 months of corrected age

Other outcomes

Sponsors and contacts

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