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Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury

Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury

Recruiting
6 years and younger
All
Phase N/A

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Overview

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.

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.

Eligibility

Inclusion Criteria:

  • Neonates of any gender
  • Neonates with gestational age \<32 weeks
  • Admitted within 6 hours of birth

Exclusion Criteria:

  • Major congenital anomalies
  • Severe birth asphyxia (Apgar \<3 at 10 min)
  • Pre-existing renal anomalies

Study details
    Preterm Birth

NCT07305935

Muhammad Aamir Latif

31 January 2026

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