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Studies kidney injury in newborns admitted to intensive care worldwide

Looks back at kidney injury in newborns cared for in intensive care units.

Key facts

Who runs it
Indiana University
Where
Szeged, HungarySee the siteAlso in 32 other countries, 124 sites
Trial code
Registry title
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Status
Enrolling by invitation
People taking part
8,000 people, planned
Started
1 Mar 2025
Expected to end
Jun 2027
Type of study
Observational
Record updated
28 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial looks back at records of newborn babies treated in a level 3 or 4 neonatal intensive care unit. It is looking for babies who received fluids through a vein for more than 48 hours.

Age
Babies up to 2 weeks old.
Sex
All sexes can join.
Earlier treatment
The baby must have received intravenous fluids for more than 48 hours.

Main reasons for not taking part

  • Age over 14 days at admission
  • Congenital heart disease needing transfer for heart care or surgery within the first 7 days
  • Lethal chromosomal anomalies
  • Death of the newborn within 48 hours

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • All infants born or admitted to a participating level 3 or 4 NICU between 1/1/19- 3/31/19 will be screened
  • Infants who received intravenous fluids for > 48 hours will be eligible

Who cannot take part

  • Congenital heart disease requiring transfer for escalation of CHD care and/or surgery within the first 7 days
  • Age > 14 days at admission
  • Lethal chromosomal anomalies
  • Neonatal mortality <48 hours

Where in Hungary

Also in 32 other countries, 124 sites

  • University of Szeged Children's HospitalSzeged, HungaryNo longer taking part

About the trial

What the trial wants to find out

There is a growing focus on short- and long-term kidney health in neonates, including those with acute kidney injury (AKI). AKI occurs commonly in the Neonatal Intensive Care Unit (NICU) and is associated with adverse outcomes. In addition to poor outcomes during the hospitalization, infants discharged from the NICU may have an increased burden of kidney disease during childhood. Studies of long-term kidney function in children born prematurely show a fourfold increase in chronic kidney disease (CKD) by adolescence and into adulthood.

Read full original descriptionShow less

Despite the landmark findings of the Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) study, the limitations of this study are notable. First, the AWAKEN study enrolled infants admitted in 2014, making the data now over 10 years old. Much has changed in neonatal practice (e.g. increased AKI awareness, treatment strategies). Secondly, the findings of the AWAKEN study were geographically limited. While the AWAKEN study was multi-national and multi-center, it represented only 24 centers (22 from North America, 1 from India and 1 from Australia). Finally, information collected from AWAKEN ended at hospital discharge.

The investigators seek to leverage the strength of the Neonatal Kidney Collaborative along with other organizations and collaboratives interested in neonatal kidney health to address these gaps. Therefore, the investigators are conducting a second, modified iteration of this study entitled "AWAKEN 2.0". AWAKEN 2.0 will be a multi-center multi-national retrospective analysis utilizing similar methodology to the AWAKEN study.

The group in the trial

  • Neonates at Risk of Kidney Disease

    Inclusion Criteria 1. Admitted to participating NICUs between 1/1/19- 3/31/19 2. \> 48 hours of IV fluids 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0: Towards Expanding Our Understanding of Neonatal Acute Kidney Injury
Plain-language title
Studies kidney injury in newborns admitted to intensive care worldwideGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
28 October 2026