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Not yet recruiting NCT06731205

Long-term Renal Prognosis of Neonatal Acute Kidney Injury

Observational Neonatal Acute Kidney Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neonatal Acute Kidney Injury. Basic parameters: up to 28 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Incidence of chronic kidney disease (CKD) [Time frame: 1-3 years]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06731205 · [2024]442A01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗