Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Muhammad Aamir Latif
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Acute Kidney Injury
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Hour to 6 Hours (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Supportive Care Group
Neonates will be given supportive care without caffeine
Intervention: Supportive care (Drug)
Early Caffeine Group
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.
Intervention: Caffeine (Drug)
Outcomes
Primary Outcomes
Acute Kidney Injury
Time Frame: 14 days
Incidence of AKI within the first 14 days of life.
Secondary Outcomes
- Duration of Acute Kidney Injury(Up to 30 days)
- Length of Hospital Stay(Up to 30 days)
- Mortality(Up to 30 days)
Investigators
Muhammad Aamir Latif
Research Consultant
RESnTEC, Institute of Research