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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Birth
• Intervention / Treatment: Drug: Caffeine; Drug: Supportive care

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 Type: Interventional
• Enrollment (Actual): 236
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Multan, Punjab Province, Pakistan, 66000
      • The Children's Hospital & The Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Experimental: Supportive Care Group; Neonates will be given supportive care without caffeine	Drug: Supportive care; Neonates will be given supportive care without caffeine.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Muhammad Aamir Latif
• Investigators: Principal Investigator: Nazia Fatima, FCPS, The Children's Hospital & The Institute of Child Health, Multan; Principal Investigator: Rabia Saleem, FCPS, The Children's Hospital & The Institute of Child Health, Multan

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Alkaloids; Purinones; Purines; Patient Care; Health Services; Health Care Facilities Workforce and Services; Xanthines; Caffeine; Palliative Care
• Other Study ID Numbers: DR-NAZIA-MULTAN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data can be shared on a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No