NCT07305935

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Muhammad Aamir Latif · Academic / Other
• Sex: All
• Age: 1 Hour – 6 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.

Conditions

• Preterm Birth

Interventions

Type	Name	Description
DRUG	Caffeine	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.
DRUG	Supportive care	Neonates will be given supportive care without caffeine.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2025-12-26
• Last updated: 2025-12-26

Locations

1 site across 1 country: Pakistan