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Urinary biomarker for predicting renal injury in high risk term newborns

Multicentric trial on role of urinary biomarkers in predicting renal injury in high risk term neonates - one year follow up

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/04/024847
Enrollment
110
Registered
2020-04-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

None listed

Sponsors

International society of Nephrology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All high risk neonates >36 weeks of gestation age are included. High risk neonates include: 1. Those with severe sepsis (any 2 organ dysfunction) or septic shock requiring mechanical ventilation or inotropic support or coagulopathy with bleeding manifestations. 2. Those with Hypoxic Ischemic Encephalopathy stage 2 or 3 (Sarnath classification). 3. Any neonate requiring major surgical intervention 4. Hemodynamically significant congenital heart disease requiring mechanical ventilation or ionotropic support. 5. Neonates requiring nephrotoxic medications â?? aminoglycosides, NSAIDS for >7 days. 6. Neonates with severe IUGR (birth weight 7. Neonates with hyperbilirubinemia requiring exchange transfusion 8. Neonates with severe dehydration ( >10% weight loss) with hypernatremia ( >145) with clinical features of dehydration with decreased urine output. 9. Neonates with PPHN/MAS on mechanical ventilation

Exclusion criteria

Exclusion criteria: Neonates with major renal anomalies like Posterior Urethral Valve and any anomalies affecting both kidneys. Parents who refuse to consent.

Design outcomes

Primary

MeasureTime frame
To find the diagnostic and prognostic efficiency of urinary biomarkers(NGAL, KIM1) in predicting AKI in high risk neonate of more than 36 week gestation age and to find incidence of AKI in high risk neonate of more than 36 week gestation ageTimepoint: First week of life or within 1 week of admission of neonate

Secondary

MeasureTime frame
To follow the renal status at 1 year in those with neonatal AKI and to find the status of urinary biomarkers at 1 year follow up in neonates with positive urinary biomarkers( based on cut off arrived)and its relation to renal statusTimepoint: 1 year follow up

Countries

India

Contacts

Public ContactThineshvaar

Mehta Multispeciality Hospitals Pvt Limited

docsudha80@yahoo.co.in9444137062

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026