Neonatal Acute Kidney InjuryNCT06731205
Long-term Renal Prognosis of Neonatal Acute Kidney Injury
An observational study of Neonatal Acute Kidney Injury, run by Guangzhou Women and Children's Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Acute Kidney Injury
- How many people
- 1,852 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Neonatal Acute Kidney Injury
- Keywords
- Neonatal Acute Kidney Injury, Long-Term Prognosis, Prognosis and Predictive Factors, Biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1-3 years
Secondary outcomes (5)
Mortality
Measured: 1-3 years
Incidence of renal replacement therapy
Measured: 1-3 years
Incidence of proteinuria
Measured: 1-3 years
Incidence of height retardation
Measured: 1-3 years
Incidence of hypertension
Measured: 1-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,852 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731205
- Sponsor's protocol ID
- [2024]442A01
- Status last verified
- Dec 2024
- First submitted
- 9 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Renal Prognosis of Neonatal Acute Kidney Injury: A Multicenter, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06731205
- Acronym / sponsor ID
- [2024]442A01
- Conditions
- Neonatal Acute Kidney Injury
- Keywords
- Neonatal Acute Kidney Injury, Long-Term Prognosis, Prognosis and Predictive Factors, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,852 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Acute Kidney Injury, run by Guangzhou Women and Children's Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Gao (86-020-38370569, gaoxiagz@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of chronic kidney disease (CKD) (time frame: 1-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.