Trials / Completed
CompletedNCT02375854
Outcomes of Neonatal Acute Kidney Injury In Premature Infants
Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Montefiore Medical Center · Academic / Other
- Sex
- All
- Age
- 1 Day – 5 Years
- Healthy volunteers
- Accepted
Summary
The objective of this protocol is to investigate the impact of prematurity, with or without associated acute kidney injury (AKI), on the future risk of chronic kidney disease (CKD) by establishing a patient registry and biorepository. Serum and urine samples will be collected serially from premature infants admitted to the neonatal intensive care unit (NICU) at Albert Einstein College of Medicine/Weiler Hospital and subsequently followed in the NICU follow-up and pediatric nephrology ambulatory subspecialty clinics. The biorepository will be linked to a comprehensive clinical database.
Detailed description
This is an observational pilot study to enhance understanding of the pathophysiology and epidemiology associated with effects of AKI in premature infants and the role that neonatal AKI plays in future development of CKD. In eligible preterm infants, blood and urine samples will be collected at pre-specified time points during hospitalization and at outpatient follow-up appointments at 6 months, 1 year, 2 years, and 5 years of age and stored in the biorepository. Blood pressure will be measured and recorded at NICU discharge and at all follow-up visits. A renal ultrasound will be performed to monitor renal growth at 2 and 5 years of age. All data will be entered into a comprehensive clinical database, including laboratory results.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observation |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2024-08-30
- Completion
- 2024-08-30
- First posted
- 2015-03-03
- Last updated
- 2024-09-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02375854. Inclusion in this directory is not an endorsement.