Health Condition 1: P019- Newborn affected by maternal complication of pregnancy, unspecified
Conditions
Interventions
Intervention1: Inj caffeine citrate: After initial resuscitation and delivery room stabilization, neonate will receive a single intravenous injection of caffeine citrate at a dose of 20 mg per kg at a
Sponsors
All India Institute of Medical Sciences, Rishikesh
Sriparna Basu
Eligibility
Inclusion criteria
Inclusion criteria: Neonates with gestational age more than equal to 35 weeks with perinatal asphyxia. Perinatal asphyxia will be defined as per the National Institutes of Child Health and Human Development criteria.
Exclusion criteria
Exclusion criteria: 1. Major congenital malformation including antenatal detected congenital anomalies of the kidneys and urinary tracts 2. Born to mothers with renal failure and beyond as per RIFLE criteria of acute kidney injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of neonates developing acute kidney injury. Acute kidney injury will be defined as per Kidney Disease Improving Global Outcomes criteria.Timepoint: Within first 7 days of life. | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of acute kidney injury, if developed 2. Levels of serum cystatin C at 24, plus minus 6 hours of life 3. Incidence and severity of hypoxic-ischemic encephalopathy 4. Incidence of seizures 5. Serial monitoring of A. aEEG background pattern B. Cranial USG and anterior cerebral artery blood flow C. Cerebral and renal regional tissue oxygenation using near-infrared spectroscopy 6. Need and duration of respiratory support 7. Adverse effects of caffeine administration 8. Morbidities during the hospital stay 9. Mortality 10. Change in weight Z score from birth to discharge 11. Hammersmith Neonatal Neurological Examination at discharge 12.Developmental screening at follow up Timepoint: During hospital stay and during follow up | — |
Countries
India
Contacts
Public ContactSriparna Basu
All India Institute of Medical Sciences, Rishikesh
Outcome results
None listed