NIRS Monitoring in the NICU and AKI

StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Apr 1, 2026 → Jul 31, 2027
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Record History

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  1. Notable Primary completion pushed from Apr 1, 2026 to Jul 31, 2027
    • Study completion pushed from Apr 1, 2026 to Jul 31, 2028
    • Start date changed from estimate of Nov 2025 to Jun 24, 2025
    • Eligibility criteria expanded, about 6 words
  2. 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.
The primary objective of this study is to describe the pattern of renal tissue oxygen saturation (SrSO2) using near-infrared spectroscopy (NIRS) in premature infants \<30 weeks gestational age. The secondary objective of this study is to evaluate prenatal and postnatal risk factors for acute kidney injury (AKI) in premature infants \<30 weeks gestational age. The investigators will also compare various rates of complications including death, length-of-stay, and prolonged duration of mechanical ventilation, among others.
Trial Details
NCT Number NCT07222722
Lead Sponsor NYU Langone Health
Conditions
(from sponsor)
Acute Kidney Injury (AKI), Postnatal AKI
Related terms Acute Kidney Injury
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov