Long-term Renal Prognosis of Neonatal Acute Kidney Injury

Long-term Renal Prognosis of Neonatal Acute Kidney Injury: A Multicenter, Prospective Cohort Study

The goal of this observational study is to conduct a multicenter, prospective neonatal acute kidney injury (AKI) follow-up cohort to describe the clinical characteristics of chronic kidney disease (CKD) in AKI cases within 1 year of follow-up and screen for effective biomarkers that can early warn of CKD progression. Ultimately, a neonatal AKI adverse prognosis warning model based on multidimensional data will be established to provide new data and new models for CKD management.

Study Overview

• Status: Not yet recruiting
• Conditions: Neonatal Acute Kidney Injury

• Study Type: Observational
• Enrollment (Estimated): 1852

Contacts and Locations

• Study Contact: Name: Xia Gao; Phone Number: 86-020-38370569; Email: gaoxiagz@vip.163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who gave birth, were admitted to NICU and were diagnosed with neonatal AKI from Jan 2025 to Dec 2025 at the Women and Children's Medical Center of Guangzhou Medical University and other hospitals participating in this project.

Description

Inclusion Criteria:

• Delivered in this hospital and subsequently admitted to the NICU during the study period;
• Diagnosed with neonatal AKI according to the 2015 KDIGO neonatal AKI criteria;
• Age <28 days.

Exclusion Criteria:

• Severe hydronephrosis diagnosed by prenatal renal ultrasound;
• Patients with congenital urinary malformations, including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal dysplasia, and obstructive uropathy;
• Newborns who required congenital heart surgery within the first 7 days after birth;
• Newborns whose mothers had a history of renal failure;
• Death within 48 hours after birth;
• Other genetic syndromes or medical conditions were not eligible for inclusion according to the attending neonatologist's judgment.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of chronic kidney disease (CKD)	The incidence of CKD stage 3-5 (eGFR < 60 ml/min) within 1, 2, and 3 years of follow-up	1-3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	1-3 years
Incidence of renal replacement therapy	1-3 years
Incidence of proteinuria	1-3 years
Incidence of height retardation	1-3 years
Incidence of hypertension	1-3 years

Collaborators and Investigators

• Sponsor: Guangzhou Women and Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 9, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; Long-Term Prognosis; Neonatal Acute Kidney Injury; Prognosis and Predictive Factors
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury; Wounds and Injuries
• Other Study ID Numbers: [2024]442A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No