NCT Number: NCT06731205
Long-term Renal Prognosis of Neonatal Acute Kidney Injury
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.
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
Up to 28 day
Sex eligibility
All sexes
Study type
Observational
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
Incidence of chronic kidney disease (CKD)
Time frame: 1-3 years
The incidence of CKD stage 3-5 (eGFR < 60 ml/min) within 1, 2, and 3 years of follow-up
Secondary outcomes
-
Mortality
Time frame: 1-3 years
-
Incidence of renal replacement therapy
Time frame: 1-3 years
-
Incidence of proteinuria
Time frame: 1-3 years
-
Incidence of height retardation
Time frame: 1-3 years
-
Incidence of hypertension
Time frame: 1-3 years
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Guangzhou Women and Children's Medical Center
Other
Registry information
Official study title
Long-term Renal Prognosis of Neonatal Acute Kidney Injury: A Multicenter, Prospective Cohort Study
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Dec 12, 2024
- Registry last updated
- Dec 31, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.