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A retrospective, multicentric, multinational study to expand the understanding of acute kidney injury in children 28 days old

AWAKEN 2.0 Towards expanding our understanding of neonatal acute kidney injury (a retrospective, multicentric, multinational cohort study) - AWAKEN 2.0

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/085299
Enrollment
4000
Registered
2025-04-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N17- Acute kidney failure

Interventions

Intervention1: NIL: NIL Intervention2: Nil: Nil Intervention3: Nil: Nil Control Intervention1: NIL: NIL

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Admitted to participating NICUs between 1/1/19- 3/31/19 2. More than 48 hours of IV fluids

Exclusion criteria

Exclusion criteria: Age more than 14 days at admission Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days Lethal chromosomal anomalies Neonatal mortality within 48 hours

Design outcomes

Primary

MeasureTime frame
Incidence of AKI in neonates (KDIGO criteria), admitted in participating NICUsTimepoint: Prior to discharge from NICU or 28 days, whichever is earlier—

Secondary

MeasureTime frame
To assess the association between mortality, length of hospital stay and risk of chronic kidney disease in newborn babies with AKI.Timepoint: Discharge and 1 year followup—

Countries

Australia, Brazil, Canada, Chile, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Lithuania, Mexico, Netherlands, Nigeria, Poland, Portugal, Slovenia, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States of America

Contacts

Public ContactDr Georgie Mathew

Christian Medical College, Vellore

callmegeorgie@gmail.com9442179258

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026