Urinary Creatinine Excretion Time in the Neonatal Period

Study acronym: C-Rex
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Nov 2025 → Jun 2027
See other at-risk trials from Central Hospital, Nancy, France

Record History

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  1. Primary completion pushed from Nov 2025 to Jun 2027
    • Study completion pushed from Dec 2025 to Sep 2027
    • Eligibility criteria expanded, about 7 words
  2. Trial status: Not Yet Recruiting to Recruitingv6 Show 4 more changesShow less
    • Primary completion date: Dec 2024 to Nov 2025
    • Study completion date: Feb 2025 to Dec 2025
    • Start date changed from estimate of Aug 2024 to Oct 30, 2024
    • Site details revised
  3. Start date: Mar 2024 to Aug 2024
    • Primary completion date: Oct 2024 to Dec 2024
    • Study completion date: Dec 2024 to Feb 2025
    v5
  4. Primary completion date: Nov 2023 to Oct 2024
    • Start date: Sep 2023 to Mar 2024
    • Study completion date: Dec 2023 to Dec 2024
    v4
  5. Start date: Jul 2023 to Sep 2023
    • Primary completion date: Jul 2023 to Nov 2023
    • Study completion date: Aug 2023 to Dec 2023
    v3
  6. Start date: May 2023 to Jul 2023v2
  7. Study First Submitted
  • 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.
Newborn's renal function is difficult to assess and its physiology during the first days of life is still incompletely known. Studies suggest that the newborn almost completely reabsorbs creatinine during the first 48 to 72 hours of life, while at the same time it continues to produce its own creatinine. Therefore, the initial stock of creatinine at birth still increases through this production and the non or weak clearance. A better knowledge of renal physiopathology in newborns would allow to improve the therapeutic management of the infants, particularly in case of potential nephrotoxicity. No study has attempted to assess the increase in urinary creatinine excretion in neonates from a given time. Objectives: To show when urinary creatinine excretion in newborns is efficient. Results: this study mightr show an inflection point in urinary creatinine excretion illustrating the postnatal age when renal function becomes efficient.
Trial Details
NCT Number NCT05813730
Lead Sponsor Central Hospital, Nancy, France
Conditions
(from sponsor)		 Renal Function
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov