Does intravenous aminophylline prevent acute kidney injury in sick babies? - A clinical trial
Phase 3
- Conditions
- Health Condition 1: P84- Other problems with newborn
- Registration Number
- CTRI/2021/11/037870
- Lead Sponsor
- Mehta Multispeciality Hospitals India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Sick term neonates defined as
1)Neonates born at =36 completed weeks of gestation (0-30 days of life) admitted to the NICU
2) Have a SNAPPE II score of more than = 40 at 12 hours of admission to NICU
Exclusion Criteria
1)Severe congenital renal anomalies at birth
2)Multiple complex congenital anomalies
3)Received theophylline or aminophylline within 7 days prior to NICU admission
4)Documented seizures prior to or after admission to NICU
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Acute Kidney Injury stage (1-3) within 72 hours of intervention as defined by modified neonatal KDIGO criteria <br/ ><br>2)Delta Urinary NGAL at 24 hours post interventionTimepoint: 24 hours and 72 hours
- Secondary Outcome Measures
Name Time Method 1)Acute Kidney Injury stage (1-3) within 7 days of intervention as defined by modified neonatal KDIGO criteria <br/ ><br>2) Delta Urine ß2 microglobulin at 24 hours post intervention <br/ ><br>3)24 hour urine output expressed as ml/kg/hour for 72 hours post intervention <br/ ><br>4)Fractional excretion of sodium calculated at 24, 48 and 72 hours after intervention <br/ ><br>5) Adverse effects attributable to IV theophyllineTimepoint: 24 hours and 7 days