Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates

NCT02443389 | Completed

• 1 other identifier: X140917002
• Study Type: observational
• Target: 2,186
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Based on single-center data, approximately 1 of every 3 newborns admitted to tertiary level neonatal intensive care units (NICU) develops acute kidney injury (AKI), and those with AKI have significantly worse outcomes. To stimulate discussion among researchers, the NIH NIDDK sponsored a workshop on neonatal AKI in April 2013. At that workshop, the group recognized the need to improve collaborations between neonatologists and nephrologists within and across centers. The investigators have created a multi-institutional, multi-disciplinary group, Neonatal Kidney Collaborative (NKC), in order to address the following critical needs identified at the workshop: AWAKEN is the inaugural study of this new collaboration.

1. 1.Development of a standardized evidence-based definition of neonatal AKI
2. 2.Evaluation of risk factors that predispose neonatal to AKI
3. 3.Investigation into how fluid provision/ balance impacts biochemical and clinical outcomes

Conditions

Acute Kidney Injury

Keywords

nephrotoxic; Fluid overload; Acute renal failure; Prematurity; Risk factors; Epidemiology

Outcome Measures

Primary Outcomes (3)

• Determine if the KDIGO AKI definition adapted to neonates can predict mortality, length of stay, and discharge serum creatinine (SCr).

  NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.

• Define the major risk factors associated with neonatal AKI. We will randomly split the cohort into two groups. We will develop a risk factor prediction model with the first group, and test the ability of the model to predict AKI with the second group.

  NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.

• Determine how fluid balance during the first few weeks of life relates to biochemical data and clinical outcomes.

  NICU admit though 18 weeks hospitalization or hospital discharge whichever comes first.

Study Arms (1)

Neonates admitted to NICU

Retrospective cohort of neonates admitted to NICU with stated inclusion and exclusion criteria

Eligibility Criteria

• Age: 1 Minute - 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will conduct a multi-center retrospective cohort study. The investigators will enroll eligible infants who meet inclusion and exclusion criteria at each center for 3 consecutive months. Based on average admissions for 2013 at our centers who meet inclusion and exclusion criteria, it is estimated that it can enroll approximately 3000 infants during this time. All infants admitted to the NICU between January 1, 2014 and march 31, 2014 will be screened for the study.

You may qualify if:

• All infants born or admitted to a level 2 or 3 NICU will be screened.
• Infants who received intravenous fluids for \> 48 hours will be eligible.

You may not qualify if:

• Infants admitted to the NICU at 2 weeks of age or older
• Infants who undergo cardiovascular surgery repair of a congenital heart lesion within 1 week of life
• Infants diagnosed with a lethal anomaly upon admission
• Infants who die within 48 hours after birth

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Children's Hospital Medical Center, Cincinnati: collaborator
• George Washington University: collaborator
• McGill University: collaborator
• Albert Einstein College of Medicine: collaborator
• University of Rochester: collaborator
• University of British Columbia: collaborator
• University of Iowa: collaborator
• University of Michigan: collaborator
• University of New Mexico: collaborator
• University of Virginia: collaborator
• University of Washington: collaborator
• University of Miami: collaborator
• Case Western Reserve University: collaborator
• University of Kentucky: collaborator
• Maimonides Medical Center: collaborator
• Stony Brook University: collaborator
• The Canberra Hospital: collaborator
• Children's Hospital Colorado: collaborator
• St. Louis Children's Hospital: collaborator
• Baylor College of Medicine: collaborator
• Medanta, The Medicity, India: collaborator
• Ohio State University: collaborator

Study Sites (1)

University of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (13)

• Selewski DT, Gist KM, Nathan AT, Goldstein SL, Boohaker LJ, Akcan-Arikan A, Bonachea EM, Hanna M, Joseph C, Mahan JD, Mammen C, Nada A, Reidy K, Staples A, Wintermark P, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in premature neonates: a report from the AWAKEN study group. Pediatr Res. 2020 Feb;87(3):550-557. doi: 10.1038/s41390-019-0579-1. Epub 2019 Sep 19.

  PMID: 31537009 BACKGROUND

• Starr MC, Boohaker L, Eldredge LC, Menon S, Griffin R, Mayock D, Askenazi D, Hingorani S; Neonatal Kidney Collaborative. Acute Kidney Injury is Associated with Poor Lung Outcomes in Infants Born >/=32 Weeks of Gestational Age. Am J Perinatol. 2020 Jan;37(2):231-240. doi: 10.1055/s-0039-1698836. Epub 2019 Nov 18.

  PMID: 31739364 BACKGROUND

• Askenazi D, Abitbol C, Boohaker L, Griffin R, Raina R, Dower J, Davis TK, Ray PE, Perazzo S, DeFreitas M, Milner L, Ambalavanan N, Cole FS, Rademacher E, Zappitelli M, Mhanna M; Neonatal Kidney Collaborative. Optimizing the AKI definition during first postnatal week using Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) cohort. Pediatr Res. 2019 Feb;85(3):329-338. doi: 10.1038/s41390-018-0249-8. Epub 2018 Dec 13.

  PMID: 30643188 BACKGROUND

• Charlton JR, Boohaker L, Askenazi D, Brophy PD, D'Angio C, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Smith A, Starr M, Kent AL; Neonatal Kidney Collaborative. Incidence and Risk Factors of Early Onset Neonatal AKI. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):184-195. doi: 10.2215/CJN.03670318. Epub 2019 Jan 31.

  PMID: 31738181 BACKGROUND

• Harer MW, Askenazi DJ, Boohaker LJ, Carmody JB, Griffin RL, Guillet R, Selewski DT, Swanson JR, Charlton JR; Neonatal Kidney Collaborative (NKC). Association Between Early Caffeine Citrate Administration and Risk of Acute Kidney Injury in Preterm Neonates: Results From the AWAKEN Study. JAMA Pediatr. 2018 Jun 4;172(6):e180322. doi: 10.1001/jamapediatrics.2018.0322. Epub 2018 Jun 4.

  PMID: 29610830 BACKGROUND

• Kraut EJ, Boohaker LJ, Askenazi DJ, Fletcher J, Kent AL; Neonatal Kidney Collaborative (NKC). Incidence of neonatal hypertension from a large multicenter study [Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates-AWAKEN]. Pediatr Res. 2018 Aug;84(2):279-289. doi: 10.1038/s41390-018-0018-8. Epub 2018 May 23.

  PMID: 29795211 BACKGROUND

• Jetton JG, Boohaker LJ, Sethi SK, Wazir S, Rohatgi S, Soranno DE, Chishti AS, Woroniecki R, Mammen C, Swanson JR, Sridhar S, Wong CS, Kupferman JC, Griffin RL, Askenazi DJ; Neonatal Kidney Collaborative (NKC). Incidence and outcomes of neonatal acute kidney injury (AWAKEN): a multicentre, multinational, observational cohort study. Lancet Child Adolesc Health. 2017 Nov;1(3):184-194. doi: 10.1016/S2352-4642(17)30069-X.

  PMID: 29732396 BACKGROUND

• Selewski DT, Akcan-Arikan A, Bonachea EM, Gist KM, Goldstein SL, Hanna M, Joseph C, Mahan JD, Nada A, Nathan AT, Reidy K, Staples A, Wintermark P, Boohaker LJ, Griffin R, Askenazi DJ, Guillet R; Neonatal Kidney Collaborative. The impact of fluid balance on outcomes in critically ill near-term/term neonates: a report from the AWAKEN study group. Pediatr Res. 2019 Jan;85(1):79-85. doi: 10.1038/s41390-018-0183-9. Epub 2018 Sep 20.

  PMID: 30237572 BACKGROUND

• Kirkley MJ, Boohaker L, Griffin R, Soranno DE, Gien J, Askenazi D, Gist KM; Neonatal Kidney Collaborative (NKC). Acute kidney injury in neonatal encephalopathy: an evaluation of the AWAKEN database. Pediatr Nephrol. 2019 Jan;34(1):169-176. doi: 10.1007/s00467-018-4068-2. Epub 2018 Aug 28.

  PMID: 30155763 BACKGROUND

• Charlton JR, Boohaker L, Askenazi D, Brophy PD, Fuloria M, Gien J, Griffin R, Hingorani S, Ingraham S, Mian A, Ohls RK, Rastogi S, Rhee CJ, Revenis M, Sarkar S, Starr M, Kent AL; Neonatal Kidney Collaborative (NKC). Late onset neonatal acute kidney injury: results from the AWAKEN Study. Pediatr Res. 2019 Feb;85(3):339-348. doi: 10.1038/s41390-018-0255-x. Epub 2018 Dec 13.

  PMID: 30546043 BACKGROUND

• Jetton JG, Guillet R, Askenazi DJ, Dill L, Jacobs J, Kent AL, Selewski DT, Abitbol CL, Kaskel FJ, Mhanna MJ, Ambalavanan N, Charlton JR; Neonatal Kidney Collaborative. Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates: Design of a Retrospective Cohort Study. Front Pediatr. 2016 Jul 19;4:68. doi: 10.3389/fped.2016.00068. eCollection 2016.

  PMID: 27486571 BACKGROUND

• Kent AL, Charlton JR, Guillet R, Gist KM, Hanna M, El Samra A, Fletcher J, Selewski DT, Mammen C. Neonatal Acute Kidney Injury: A Survey of Neonatologists' and Nephrologists' Perceptions and Practice Management. Am J Perinatol. 2018 Jan;35(1):1-9. doi: 10.1055/s-0037-1604260. Epub 2017 Jul 14.

  PMID: 28709164 BACKGROUND

• Stoops C, Boohaker L, Sims B, Griffin R, Selewski DT, Askenazi D; on behalf of the National Kidney Collaborative (NKC). The Association of Intraventricular Hemorrhage and Acute Kidney Injury in Premature Infants from the Assessment of the Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) Study. Neonatology. 2019;116(4):321-330. doi: 10.1159/000501708. Epub 2019 Aug 28.

  PMID: 31461717 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Edema; Premature Birth

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Study Officials

• David Askenazi, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 120 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MsPH, Associate Professor

Study Record Dates

• First Submitted: May 11, 2015
• First Posted: May 13, 2015
• Study Start: March 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)