xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031025</url>
    </required_header>
    <id_info>
      <org_study_id>4921</org_study_id>
      <nct_id>NCT06031025</nct_id>
    </id_info>
    <brief_title>Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.</brief_title>
    <acronym>FUSID</acronym>
    <official_title>Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn about the prevalence and characteristics of&#xD;
        functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and&#xD;
        those with birth asphyxia) during the first 2 years of life. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  evaluate the prevalence of symptoms related to GER, of functional gastrointestinal&#xD;
             disorders during the first 2 years of life&#xD;
  &#xD;
          -  describe growth parameters during follow-up up to the corrected age of 2 years&#xD;
             Participants will be assessed clinically and with a structured questionnaire based on&#xD;
             the Rome IV criteria to describe FGID.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Infants will undergo clinical assessment at 3, 6, 12, 24 months' corrected age at the local&#xD;
        Follow-up clinic.&#xD;
  &#xD;
        Clinical examination, anthropometric measurement and data from a structured questionnaire to&#xD;
        detect FGID will be performed.&#xD;
  &#xD;
        Z-scores for weight, length and head circumference will be calculated according to the WHO&#xD;
        standards.&#xD;
  &#xD;
        Data from the questionnaires will be collected. Clinical characteristics of patients and&#xD;
        perinatal data will be collected and analyzed by appropriate statistical methods.&#xD;
  &#xD;
        The prevalence and characteristics of FGID in the study population will be compared to&#xD;
        published data (mostly from term infants).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 20, 2022</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Prevalence and characteristics of FGID</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Occurrence of FGID (percentage of patients)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence and characteristics of FGID</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Frequency of FGID (i.e. number of symtoms per day)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Prevalence and characteristics of FGID</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Severity (scales from 0 to 10 for increasing values) of FGID</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Somatic growth: weight</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Somatic growth: head circumference</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Somatic growth: length</measure>
      <time_frame>3, 6, 12, 24 months of corrected age</time_frame>
      <description>Measurement of length and calculation of z-scores based on reference standards by the World Health Organization</description>
    </secondary_outcome>
    <enrollment type="Anticipated">71</enrollment>
    <condition>Functional Gastrointestinal Disorders</condition>
    <condition>Gastroesophageal Reflux</condition>
    <condition>Constipation - Functional</condition>
    <condition>Diarrhea</condition>
    <condition>Dyschezia</condition>
    <condition>Colic, Infantile</condition>
    <condition>Vomiting; Cyclical</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire, clinical examination</intervention_name>
      <description>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.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Infants matching the inclusion criteria will be enrolled in the local Follow-up program (as&#xD;
          per clinical routine of the local Institution).&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  infants with gestational age at birth &lt; 31 weeks&#xD;
  &#xD;
            -  infants with gestational age at birth &lt; 37 weeks and major respiratory or neurologic&#xD;
               morbidity&#xD;
  &#xD;
            -  infants with history of perinatal asphyxia&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  lack of informed consent&#xD;
  &#xD;
            -  diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory&#xD;
               bowel disease, cancer)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Months</minimum_age>
      <maximum_age>24 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stefano Nobile, MD, PhD, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Fondazione Policlinico Universitario A. Gemelli, IRCCS</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stefano Nobile, MD, PhD, MSc</last_name>
      <phone>+390630156937</phone>
      <email>stefano.nobile@policlinicogemelli.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Fondazione Policlinico Gemelli IRCCS</name>
        <address>
          <city>Roma</city>
          <zip>00168</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefano Nobile, MD, PhD, MSc</last_name>
        <phone>+390630156937</phone>
        <email>stefano.nobile@policlinicogemelli.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <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>
      <PMID>32446468</PMID>
    </results_reference>
    <results_reference>
      <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>
      <PMID>29398057</PMID>
    </results_reference>
    <results_reference>
      <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>
      <PMID>27144631</PMID>
    </results_reference>
    <results_reference>
      <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>
      <PMID>15893282</PMID>
    </results_reference>
    <results_reference>
      <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.</citation>
      <PMID>36705695</PMID>
    </results_reference>
    <verification_date>September 2022</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroesophageal Reflux</mesh_term>
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
      <mesh_term>Colic</mesh_term>
      <mesh_term>Constipation</mesh_term>
      <mesh_term>Vomiting</mesh_term>
      <mesh_term>Diarrhea</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031025
  org study id: 4921
  nct id: NCT06031025
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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 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.
  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 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).
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence and characteristics of FGID
  time frame: 3, 6, 12, 24 months of corrected age
  description: Occurrence of FGID (percentage of patients)
  measure: Prevalence and characteristics of FGID
  time frame: 3, 6, 12, 24 months of corrected age
  description: Frequency of FGID (i.e. number of symtoms per day)
  measure: Prevalence and characteristics of FGID
  time frame: 3, 6, 12, 24 months of corrected age
  description: Severity (scales from 0 to 10 for increasing values) of FGID
  measure: Somatic growth: weight
  time frame: 3, 6, 12, 24 months of corrected age
  description: Measurement of weight and calculation of z-scores based on reference standards by the World Health Organization
  measure: Somatic growth: head circumference
  time frame: 3, 6, 12, 24 months of corrected age
  description: Measurement of head circumference and calculation of z-scores based on reference standards by the World Health Organization
  measure: Somatic growth: length
  time frame: 3, 6, 12, 24 months of corrected age
  description: Measurement of length and calculation of z-scores based on reference standards by the World Health Organization
  intervention type: Other
  intervention name: Questionnaire, clinical examination
  description: 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.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 3 Months
  maximum age: 24 Months
  healthy volunteers: No
  last name: Stefano Nobile, MD, PhD, MSc
  role: Principal Investigator
  affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
  last name: Stefano Nobile, MD, PhD, MSc
  phone: +390630156937
  email: stefano.nobile@policlinicogemelli.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  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.
  PMID: 32446468
  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.
  PMID: 29398057
  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.
  PMID: 27144631
  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.
  PMID: 15893282
  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.
  PMID: 36705695
  responsible party type: Sponsor
  mesh term: Gastroesophageal Reflux
  mesh term: Gastrointestinal Diseases
  mesh term: Digestive System Diseases
  mesh term: Colic
  mesh term: Constipation
  mesh term: Vomiting
  mesh term: Diarrhea
  sharing ipd: Undecided