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

NCT ID: NCT07305935

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Preterm Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Caffeine

Intervention Type 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 Group

Neonates will be given supportive care without caffeine

Group Type EXPERIMENTAL

Supportive care

Intervention Type DRUG

Neonates will be given supportive care without caffeine.

Interventions

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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.

Intervention Type DRUG

Supportive care

Neonates will be given supportive care without caffeine.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Hour

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhammad Aamir Latif

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Aamir Latif

Research Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nazia Fatima, FCPS

Role: PRINCIPAL_INVESTIGATOR

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

Rabia Saleem, FCPS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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The Children's Hospital & The Institute of Child Health

Multan, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Nazia Fatima, FCPS

Role: CONTACT

Phone: +923334179233

Email: [email protected]

Rabia Saleem, FCPS

Role: CONTACT

Phone: +923337610846

Email: [email protected]

Facility Contacts

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Nazia Fatima, FCPS

Role: primary

Rabia Saleem, PCPS

Role: backup

Other Identifiers

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DR-NAZIA-MULTAN

Identifier Type: -

Identifier Source: org_study_id