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

Muhammad Aamir Latif

Status: Enrolling

Conditions: Preterm Birth

Treatments: Drug: Supportive care; Drug: Caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT07305935

DR-NAZIA-MULTAN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 1 to 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 2 patient groups

Early Caffeine Group

Experimental group

Description:

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.

Treatment:

Drug: Caffeine

Supportive Care Group

Experimental group

Description:

Neonates will be given supportive care without caffeine

Treatment:

Drug: Supportive care