Monitoring kidney oxygen with NIRS in babies born before 30 weeks
Near Infrared Spectroscopy (NIRS) Monitoring as an Early Predictor of Acute Kidney Injury (AKI) in a Vulnerable Neonatal Intensive Care Unit (NICU) Population
This will test whether near-infrared spectroscopy (NIRS) can track kidney oxygen levels in babies born before 30 weeks to spot patterns linked to acute kidney injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 24 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07222722 on ClinicalTrials.gov |
What this trial studies
The study will use near-infrared spectroscopy (NIRS) to measure renal tissue oxygen saturation (SrSO2) in premature infants born before 30 weeks gestation. Continuous or repeated NIRS readings will be recorded in the NICU to characterize oxygenation patterns over time. Investigators will analyze prenatal and postnatal risk factors for acute kidney injury and compare outcomes such as death, length of stay, and prolonged mechanical ventilation. Infants with major congenital kidney anomalies or those too small/immature for safe monitoring are excluded.
Who should consider this trial
Good fit: Premature infants born before 30 weeks gestation at the participating NICU whose parents can provide consent and who do not have major congenital kidney anomalies are ideal candidates.
Not a fit: Infants with major congenital kidney malformations, those under 24 weeks gestation or under 500 grams, or those for whom clinicians judge NIRS unsuitable likely will not benefit.
Why it matters
Potential benefit: If successful, earlier detection of low kidney oxygen could prompt earlier interventions and reduce rates of acute kidney injury and related complications.
How similar studies have performed: Prior research has used NIRS to monitor neonatal renal oxygenation and found associations with kidney injury risk, but the approach has not yet been proven to prevent AKI or change long-term outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sourabh Verma, MD — NYU Langone Health
- Study coordinator: Jordan Nelson, MD
- Email: Jordan.nelson@nyulangone.org
- Phone: 3478223664
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.