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

Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07305935

Enrollment

236

Registered

2025-12-26

Start date

2025-10-01

Completion date

2026-03-31

Last updated

2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm Birth

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.

Interventions

DRUGCaffeine

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.

DRUGSupportive care

Neonates will be given supportive care without caffeine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 6 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Acute Kidney Injury	14 days	Incidence of AKI within the first 14 days of life.

Secondary

Measure	Time frame	Description
Duration of Acute Kidney Injury	Up to 30 days	Time duration between onset of AKI and resolution.
Length of Hospital Stay	Up to 30 days	Time duration from admission to discharge.
Mortality	Up to 30 days	Mortality will be labelled when a patient expires during a hospital stay.

Countries

Pakistan

Contacts

PRINCIPAL_INVESTIGATORNazia Fatima, FCPS

The Children's Hospital & The Institute of Child Health, Multan

PRINCIPAL_INVESTIGATORRabia Saleem, FCPS