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NCT Number: NCT07222722

NIRS Monitoring in the NICU and AKI

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.

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Key information

Conditions

Acute Kidney Injury (AKI) Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Postnatal AKI Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

24 week–30 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Any neonate less than 30 weeks in gestational age
  • Willingness and capacity of both adult parents/guardians to sign consent

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Average NIRS Value (SrSO2)

    Time frame: Up to Day-of-life 7

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

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)

  5. Duration of Mechanical Ventilation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jordan Nelson, MD

CONTACT

[email protected]

3478223664

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

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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