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OpenTrials
Completed

NCT Number: NCT02375854

Outcomes of Neonatal Acute Kidney Injury In Premature Infants

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

observation

Other

Primary outcomes

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

    Time frame: 5 years

    Determine the incidence of chronic renal insufficiency in childhood

Secondary outcomes

  1. Acute kidney injury (incidence of acute kidney injury in preterm infants)

    Time frame: 0-5 months

    Determine the incidence of acute kidney injury in preterm infants

  2. Assessment of serum biomarkers - cystatin C

    Time frame: 0 months - 5 years

    Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency

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

    Time frame: 0 months - 5 years

    Determination of serum and urinary biomarkers to predict the development of acute kidney injury and chronic renal insufficiency

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

Outcomes of Neonatal Acute Kidney Injury and Prematurity: An Observational Study and Einstein-Montefiore Neonatal Acute Kidney Injury Clinical Registry and Biorepository

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2015
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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