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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preterm infants | Less than 32 weeks' gestation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chronic kidney disease (incidence of chronic renal insufficiency in childhood) | Determine the incidence of chronic renal insufficiency in childhood | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury (incidence of acute kidney injury in preterm infants) | Determine the incidence of acute kidney injury in preterm infants | 0-5 months |
| Assessment of serum biomarkers - cystatin C |
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Inclusion Criteria:
Exclusion Criteria:
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Preterm infants less than 32 weeks' gestational age
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| Name | Affiliation | Role |
|---|---|---|
| Mamta Fuloria, MD | The Children's Hospital at Montefiore, Albert Einstein College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jack D. Weiler Hospital | The Bronx | New York | 10461 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D051436 | Renal Insufficiency, Chronic |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood and urine samples
Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency
| 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 | 0 months - 5 years |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |