Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Launched by INDIANA UNIVERSITY · Feb 7, 2025
Trial Information
Current as of April 27, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
AWAKEN 2.0 is a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study. The investigators will capture information on all infants admitted to participating level 3 and 4 NICUs between January 1-March 31, 2019, to answer specific hypothesis regarding the following three inter-connected but independent specific aims:
Specific Aim 1. Describe prevalence of AKI in a multi-national multi-center retrospective cohort, 5 years after the original AWAKEN study.
1. Primary hypothesis: The investigators hypothesize that rates of neonatal AKI are higher th...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened.
- • 2. Infants who received intravenous fluids for \> 48 hours will be eligible.
- Exclusion Criteria:
- • 1. Age \> 14 days at admission
- • 2. Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days
- • 3. Lethal chromosomal anomalies
- • 4. Neonatal mortality \<48 hours
About Indiana University
Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Indianapolis, Indiana, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported