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

NCT07305935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Muhammad Aamir Latif

    lead OTHER

Principal Investigators

  • Nazia Fatima, FCPS · The Children's Hospital & The Institute of Child Health, Multan

  • Rabia Saleem, FCPS · The Children's Hospital & The Institute of Child Health, Multan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305935 on ClinicalTrials.gov