An observational study in Acute Kidney Injury and Chronic Kidney Disease, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 1 Day to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Montefiore Medical Center · Observational
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.
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.
1,641 studies on the registry are indexed under Acute Kidney Injury; 380 are open to participants now.
This study's enrollment of 25 is below the median of 156 across 795 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.
Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Preterm infants less than 32 weeks' gestational age
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Exclusion Criteria:
Less than 32 weeks' gestation
Other: Observation
Chronic kidney disease (incidence of chronic renal insufficiency in childhood)
Determine the incidence of chronic renal insufficiency in childhood
Time frame: 5 years
Acute kidney injury (incidence of acute kidney injury in preterm infants)
Determine the incidence of acute kidney injury in preterm infants
Time frame: 0-5 months
Assessment of serum biomarkers - cystatin C
Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency
Time frame: 0 months - 5 years
Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1
Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency
Time frame: 0 months - 5 years
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2014 to primary completion in Aug 2024, 117 months.
Of 337 non-industry observational studies under Acute Kidney Injury, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 41. This study's 117 months is above that.
Counting every sponsor, half of 350 studies reached it within 24 months; a quarter within 13 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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