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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
236
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.
The Children's Hospital & The Institute of Child Health
Multan, Punjab Province, Pakistan
RECRUITINGAcute Kidney Injury
Incidence of AKI within the first 14 days of life.
Time frame: 14 days
Duration of Acute Kidney Injury
Time duration between onset of AKI and resolution.
Time frame: Up to 30 days
Length of Hospital Stay
Time duration from admission to discharge.
Time frame: Up to 30 days
Mortality
Mortality will be labelled when a patient expires during a hospital stay.
Time frame: Up to 30 days
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