Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT07262060
Description:
This study will submit data to the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (DASH). NICHD DASH is a NICHD-funded controlled access data repository established to facilitate data sharing and access to biospecimens for all NICHD clinical research. This study will produce four data types: Clinical data, Urine proteomic biomarker, PK/PD data, and near infrared spectroscopy (NIRS) oxygenation data. The final clinical dataset will include demographic data and study-related tests obtained from the electronic medical record. The urine proteomic data will contain output from the biological urine samples from each research subject. The PK/PD data will contain caffeine serum concentration and renal oxygenation data at various timepoints, dose levels, and selected demographic and clinical data. The NIRS oxygenation dataset will include every 1 second kidney and cerebral oxygenation percentage generated/obtained from INVOS Medtronic NIRS 7100 devices.
Study:
NCT07262060
Study Brief:
Improving Preterm Kidney Outcomes With Caffeine