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Completed

NCT Number: NCT07305935

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

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.

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Key information

Conditions

Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 hour–6 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital & The Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine

Drug

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.

Supportive care

Drug

Neonates will be given supportive care without caffeine.

Primary outcomes

  1. Acute Kidney Injury

    Time frame: 14 days

    Incidence of AKI within the first 14 days of life.

Secondary outcomes

  1. Duration of Acute Kidney Injury

    Time frame: Up to 30 days

    Time duration between onset of AKI and resolution.

  2. Length of Hospital Stay

    Time frame: Up to 30 days

    Time duration from admission to discharge.

  3. Mortality

    Time frame: Up to 30 days

    Mortality will be labelled when a patient expires during a hospital stay.

Sponsors and collaborators

Lead sponsor

Muhammad Aamir Latif

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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