Health TrialsbyHealthPanel

NIRS Monitoring in the NICU and AKI

ConditionsAcute Kidney Injury (AKI)Postnatal AKI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-30
SponsorNYU Langone Health

About this trial

The primary objective of this study is to describe the pattern of renal tissue oxygen saturation (SrSO2) using near-infrared spectroscopy (NIRS) in premature infants \<30 weeks gestational age. The secondary objective of this study is to evaluate prenatal and postnatal risk factors for acute kidney injury (AKI) in premature infants \<30 weeks gestational age. The investigators will also compare various rates of complications including death, length-of-stay, and prolonged duration of mechanical ventilation, among others.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Any neonate less than 30 weeks in gestational age

Willingness and capacity of both adult parents/guardians to sign consent

Disqualifiers

An infant with known congenital anomalies of the kidney (i.e., grade 4 or 5 vesicoureteral reflux (VUR), posterior urethral valves, moderate or severe hydronephrosis, autosomal recessive polycystic kidney disease (ARPKD), bilateral renal agenesis or dysplasia)

Age >30 weeks gestational age

Age <24 weeks and <500 grams (will be excluded due to sensitivity of skin in this vulnerable population).

Clinician's decision that NIRS is not suitable due to the patient's clinical condition

Trial design

Design model

Single group

Treatments tested in this trial

  • NIRS Monitoring

    Device

    The renal NIRS device is a non-invasive tool that uses near-infrared light to measure oxygen saturation various tissues. Renal NIRS sensors will be placed by 24 hours of the participants' admission.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: NICU patients born less than 30 weeks gestational ageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Average NIRS Value (SrSO2)

NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life.

Time frame
Up to Day-of-life 7

Secondary outcomes

1

Serum Creatinine Values

Time frame
Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14
2

Average Urine Output

Time frame
Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
3

Length-of-Stay in NICU

Time frame
Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)
4

Duration of Non-Invasive Ventilation

Time frame
Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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