Outcomes of Neonatal Acute Kidney Injury In Premature Infants

NCT02375854 | Completed

• 1 other identifier: 2013-2900
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Kidney Injury; Chronic Kidney Disease

Keywords

preterm; acute kidney injury; biomarkers; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• Chronic kidney disease (incidence of chronic renal insufficiency in childhood)

  Determine the incidence of chronic renal insufficiency in childhood

  5 years

Secondary Outcomes (3)

• Acute kidney injury (incidence of acute kidney injury in preterm infants)

  0-5 months

• Assessment of serum biomarkers - cystatin C

  0 months - 5 years

• Assessment of urinary biomarkers - urinary neutrophil gelatinase-associated lipocalin, interlukin 18 and kidney-injury molecule-1

  0 months - 5 years

Study Arms (1)

Preterm infants

Less than 32 weeks' gestation

Other: Observation

Interventions

Observation OTHER

Preterm infants

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Preterm infants less than 32 weeks' gestational age

You may qualify if:

• Preterm infants less than 32 weeks/ gestational age admitted to the Neonatal Intensive Care Unit at Weiler Hospital (The Children's Hospital at Montefiore).

You may not qualify if:

• Known major congenital anomalies of the kidney and urinary tract (CAKUT) including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal hypoplasia, obstructive uropathy
• Other genetic syndromes or medical conditions that preclude enrollment per judgment of the attending neonatologist

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Acute Kidney Injury; Renal Insufficiency, Chronic; Premature Birth

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Mamta Fuloria, MD

  The Children's Hospital at Montefiore, Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: March 3, 2015
• Study Start: November 1, 2014
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)