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

NCT07305935 | Completed

• 1 other identifier: DR-NAZIA-MULTAN
• Study Type: interventional
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  Incidence of AKI within the first 14 days of life.

  14 days

Secondary Outcomes (3)

• Duration of Acute Kidney Injury

  Up to 30 days

• Length of Hospital Stay

  Up to 30 days

• Mortality

  Up to 30 days

Study Arms (2)

Early Caffeine Group

EXPERIMENTAL

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

Supportive Care Group

EXPERIMENTAL

Neonates will be given supportive care without caffeine

Drug: Supportive care

Interventions

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.

Early Caffeine Group

Supportive care DRUG

Neonates will be given supportive care without caffeine.

Supportive Care Group

Eligibility Criteria

• Age: 1 Hour - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates of any gender
• Neonates with gestational age \<32 weeks
• Admitted within 6 hours of birth

You may not qualify if:

• Major congenital anomalies
• Severe birth asphyxia (Apgar \<3 at 10 min)
• Pre-existing renal anomalies

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

The Children's Hospital & The Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Caffeine; Palliative Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 26, 2025
• Study Start: October 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)