Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT00061828 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Prospective Database of Infants With Cholestasis

Study acronym: PROBE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Site details revised at 1 of 16 sites

    Study Status, Oversight, Contacts/Locationsv35

  2. Minor

    Study Identification, Study Status

    Re-verified, no change to tracked fields

    v34

  3. Minor

    Eligibility criteria shortened, about 2 words

    Study description shortened, about 178 words; Site details revised at 10 of 16 sites; Study arms: 2 to 1

    Show what changed: Eligibility criteria
    INCLUSION CRITERIA Infant's age less than or equal to 180 days at initial presentation at the ChiLDRENChiLDReN clinical site. Diagnosis of cholestasis defined by serum direct or conjugated bilirubin greater than 20% of total and greater than or equal to 2 mg/dl and suspected biliary atresia. The subject's parent(s)/guardian(s) willing to provide inf [...]
    Show what changed: Study description
    This is a multi-center project to establish a prospective database of clinical information and a repository of blood, and tissue samples from children with diagnosesdiagnosis of neonatal liver diseasesdisease, such as biliary atresia (BA), idiopathic neonatal hepatitis (INH), and specific neonatal presentations of genetic cholestatic disorders in order to perform research in thesethis important liver problemsproblem. Children (diagnosed with BA or suspicious for BA) will be screened and enrolled at presentation at the partic [...] he first year, at 18 months of age, and then annually up to 2010 years [...] [...]

    Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locationsv33

  4. Minor

    Primary and study completion dates: May 2029 to May 31, 2029

    Study Status, Oversightv32

  5. Notable

    Primary and study completion dates: May 2024 to May 2029

    Study Statusv31

Show 29 earlier versions

  1. Minor

    Site contacts updated at 4 of 16 sites

    Study Status, Contacts/Locationsv30

  2. Minor

    Site contacts updated at 1 of 16 sites

    Study Status, Contacts/Locationsv29

  3. Minor

    Study Status

    Re-verified, no change to tracked fields

    v28

  4. Minor

    Site contacts updated at 10 of 16 sites

    Study Status, Contacts/Locationsv27

  5. Minor

    Start date: May 2004 to Apr 21, 2004

    Study Statusv26

  6. Notable

    Trial status: Suspended to Recruiting

    Site details revised at 16 of 16 sites

    Study Status, Contacts/Locationsv25

  7. Stopped

    Trial status: Recruiting to Suspended

    Sponsor's reason: Study visits suspended due to COVID-19 pandemic.

    Site details revised at 16 of 16 sites

    Study Status, Contacts/Locationsv24

  8. Minor

    Eligibility criteria expanded, about 6 words

    Study description expanded, about 13 words; Site contacts updated at 3 of 16 sites

    Show what changed: Eligibility criteria
    [...] isease being studied by ChiLDREN). Diagnosis of any drug or Total parenteral nutrition (TPN)-associated cholestasis (except when diagnosed with biliary [...] lestatic disease being studied by ChiLDREN). Diagnosis with Extracorporeal membrane oxygenation (ECMO)-associated cholestasis. Birth weight less than 1500g (except when diagnosed with biliary atresia).
    Show what changed: Study description
    [...] his study will be kept in a secure research database at the DCCScientific Data Coordinating Center (SDCC) and transferred to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) data repository after the study ends.

    Study Status, Study Description, Eligibility, Contacts/Locationsv23

  9. Minor

    Site contacts updated at 3 of 16 sites

    Study Status, Contacts/Locationsv22

  10. Notable

    Primary and study completion dates: May 2019 to May 2024

    Site contacts updated at 3 of 16 sites

    Study Status, Contacts/Locationsv21

  11. Minor

    Study description shortened, about 12 words

    Study sites revised (16); Study title shortened, about 1 word

    Show what changed: Study description
    This is a multi-center project to establish a prospective database of clinical information and a repository of blood, and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and(BA), idiopathic neonatal hepatitis (INH), and specific neonatal presentations of genetic cholestatic disorders in order to perform research in these important liver probl [...] at presentation at the participating pediatric liver sites. SubjectsParticipants diagnosed with biliary atresiaBA will be followed intensively for the first year, at 18 months of age, and then annually up to [...]
    Show what changed: Study sites
    Children's Healthcare of Atlanta (- Emory University) Cincinnati Children's Hospital Medical Center UPMC Children's Hospital of Pittsburgh
    Show what changed: Study title
    PROBE: A Prospective Database of Infants With Cholestasis

    Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Eligibility, Contacts/Locations, Referencesv20

  12. Minor

    Site contacts updated at 2 of 16 sites

    Study Status, Contacts/Locationsv19

  13. Notable

    Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to Arbor Research Collaborative for Health

    Site contacts updated at 8 of 16 sites; Collaborators expanded, about 10 words; Study title expanded, about 4 words

    Show what changed: Collaborators
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
    Show what changed: Study title
    BiliaryPROBE: AtresiaA ResearchProspective ConsortiumDatabase of Infants With Cholestasis

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv18

  14. Minor

    Study sites: 15 to 16

    Eligibility criteria expanded, about 147 words; Study description expanded, about 424 words

    Show what changed: Eligibility criteria
    AgeINCLUSION CRITERIA Infant's age less than or equal to 180 days at initial presentation toat the ChiLDREN clinical site. ClinicallyDiagnosis meaningfulof cholestasis duedefined by serum direct or conjugated bilirubin greater than 20% of total and greater than or equal to primary2 mg/dl. The subject's parent(s)/guardian(s) willing to provide informed written consent. EXCLUSION CRITERIA Acute liver failure. Previous hepatobiliary surgery with dissection or excision of biliary tissue. Diagnoses of bacterial or fungal sepsis (except where associated with metabolic liver disease) Diagnoses of hyp [...] [...]
    Show what changed: Study description
    This is a multi-center project to establish a prospective database of clinical information and a repository of blood and tissue samples from children with diagnoses of neonatal liver diseases, such as biliary atresia and neonatal hepatitis, in order to perform research in these important liver probl [...]

    Study Identification, Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, Referencesv17

  15. Minor

    Primary and study completion dates: May 2019

    Study sites revised (15)

    Show what changed: Study sites
    Ann & Robert H. Lurie Children's MemorialHospital Hospitalof Chicago

    Study Status, Contacts/Locationsv16

  16. Notable

    Enrollment target: 400 to 1000

    Study sites: 14 to 15

    Study Status, Study Design, Contacts/Locationsv15

  17. Minor

    Study sites: 10 to 14

    Study Status, Sponsor/Collaborators, Contacts/Locationsv14

  18. Minor

    6 amendments

    6 re-verifications since 2008-07-11, no change to tracked fields

    v8-v13

  19. Minor

    Site contacts updated at 3 of 10 sites

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Eligibility, Contacts/Locationsv7

  20. Minor

    2 amendments

    2 re-verifications since 2006-12-11, no change to tracked fields

    v5-v6

  21. Minor

    Study sites revised (10)

    Show what changed: Study sites
    Texas Children's Hospital/Baylor College of Medicine

    Study Status, Contacts/Locationsv4

  22. Minor

    Study sites: 9 to 10

    Start date: May 2004

    Study Identification, Study Status, Contacts/Locations, Referencesv3

  23. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Biliary atresia, idiopathic neonatal hepatitis, and specific genetic cholestatic conditions are the most common causes of jaundice and hyperbilirubinemia that continue beyond the newborn period. The long term goal of the Childhood Liver Disease Research Network (ChiLDReN) is to establish a database of clinical information and plasma, serum, and tissue samples from cholestatic children to facilitate research and to perform clinical, epidemiological and therapeutic trials in these important pediatric liver diseases.
Trial Details
NCT Number NCT00061828
Lead Sponsor Arbor Research Collaborative for Health
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Biliary Atresia
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov