Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury
Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates
Muhammad Aamir Latif
236 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
Summary
Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.
Eligibility
Inclusion Criteria3
- Neonates of any gender
- Neonates with gestational age <32 weeks
- Admitted within 6 hours of birth
Exclusion Criteria3
- Major congenital anomalies
- Severe birth asphyxia (Apgar <3 at 10 min)
- Pre-existing renal anomalies
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Interventions
Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.
Neonates will be given supportive care without caffeine.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07305935