Health Condition 1: P84- Other problems with newborn
Conditions
Interventions
Intervention1: Intravenous aminophylline: Single dose of intravenous aminophylline at 8mg/kg/dose
Control Intervention1: Placebo: Normal saline as placebo
Sponsors
Mehta Multispeciality Hospitals India Pvt Ltd
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Acute Kidney Injury stage (1-3) within 72 hours of intervention as defined by modified neonatal KDIGO criteria 2)Delta Urinary NGAL at 24 hours post interventionTimepoint: 24 hours and 72 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Acute Kidney Injury stage (1-3) within 7 days of intervention as defined by modified neonatal KDIGO criteria 2) Delta Urine ß2 microglobulin at 24 hours post intervention 3)24 hour urine output expressed as ml/kg/hour for 72 hours post intervention 4)Fractional excretion of sodium calculated at 24, 48 and 72 hours after intervention 5) Adverse effects attributable to IV theophyllineTimepoint: 24 hours and 7 days | — |
Countries
India
Contacts
Public ContactSUKANYA GOVINDAN
Mehta Multispeciality Hospitals India Private Limited
Outcome results
None listed