NIRS Monitoring to Detect AKI in Preterm Infants (nNIRS-AKI)

University of Wisconsin (UW)

Status: Completed

Conditions: Acute Kidney Injury; Premature Infant

Treatments: Device: Near Infrared Spectroscopy

Study type: Observational

Funder types: Other

Identifiers

NCT03384173

SMPH/PEDIATRICS/PEDIATRICS (Other Identifier)

A536757 (Other Identifier)

2017-013 (Other Identifier)

2017-0589

Details and patient eligibility

About

This study will examine the relationship of oxygen levels, using Near-infrared spectroscopy (NIRS) monitoring, and kidney injury in infants born prematurely. NIRS is a skin sensor which detects the amount of oxygen going to different organs, most often used to monitor the brain and kidney.

Full description

This prospective, single-center study was conducted at UnityPoint Health-Meriter Hospital (Madison, WI, USA) in preterm neonates admitted to a level III NICU from April 2018 to August 2019. The primary study aim was to assess changes in RrSO2 with continuous renal NIRS monitoring to detect AKI during the first 7 days of age.

The INVOS 5100 C (Somanetics, Troy, MI, USA) four channel NIRS monitors were used to measure RrSO2 (measured at the right or left flank) and Cerebral regional Somatic tissue Oxygenation (CrSO2; measured at the forehead) for all neonates. At each measurement site, for skin protection, subjects had a transparent Mepitel (with Safetac Technology, Norcross, GA) adhesive dressing placed with the adhesive neonatal NIRS sensor (INVOS OxyAlert NIRSensor, Covidien) adhered over the Mepitel dressing. Neither cerebral or kidney sensors were placed with ultrasound guidance. Tissue oxygenation was recorded every 3 seconds until 7 days of age, and the sensor was changed one time when the patient reached three to four days of age per the company's recommendation. There were no restrictions on positioning or handling of neonates; nurses re-positioned neonates every 3-6 hours per unit protocol to prevent skin pressure injuries. Researchers, staff, and parents were blinded to RrSO2 values.

Enrollment: 35 patients

Sex: All

Ages: 1 minute to 7 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Preterm infants < 32 weeks
• Admitted to Unity Point Health(UPH) Meriter Newborn Intensive Care Unit (NICU)
• Application of NIRS by 48 hours of age

Exclusion criteria

• Congenital anomaly of the kidney or urinary tract (CAKUT)

Trial design

35 participants in 1 patient group

NIRS monitoring

Description:

These infants will be monitored with NIRS

Treatment:

Device: Near Infrared Spectroscopy