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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NICU patients born less than 30 weeks gestational age | Experimental | All patients included in the study will be assigned to receive NIRS monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Average NIRS Value (SrSO2) | NIRS values measured as renal tissue oxygen saturation (SrSO2); measured continuously over first 7 days of life. | Up to Day-of-life 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Creatinine Values | Day-of-life 1, Day-of-life 3, Day-of-life 7, Day-of-life 14 | |
| Average Urine Output | Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Nelson, MD | Contact | 3478223664 | Jordan.nelson@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Sourabh Verma, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Jordan.nelson@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Jordan.nelson@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Length-of-Stay in NICU | Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations) |
| Duration of Non-Invasive Ventilation | Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations) |
| Duration of Mechanical Ventilation | Up to Day of NICU Discharge (Approximately Day-of-life 7; subject to large individual variations) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |