Early caffeine versus supportive care to prevent acute kidney injury in preterm infants

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

This trial tests whether giving caffeine very early to babies born before 32 weeks lowers the risk of acute kidney injury compared with standard supportive care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 1 Hour to 6 Hours
• Sex: All
• Sponsor: RESnTEC, Institute of Research (Academic / other)
• Locations: 1 site (Multan, Punjab Province)
• Trial ID: NCT07305935 on ClinicalTrials.gov

What this trial studies

This interventional trial compares early caffeine administration to standard supportive therapy in preterm neonates born before 32 weeks and admitted within six hours of birth. Eligible infants are assigned to receive early caffeine or supportive care and are monitored for the development and severity of acute kidney injury as well as clinical outcomes such as duration of mechanical ventilation, length of hospital stay, and neonatal mortality. Key exclusions include major congenital anomalies, severe birth asphyxia (Apgar <3 at 10 minutes), and known renal anomalies. The trial seeks to generate higher-quality evidence than prior observational reports to guide clinicians on whether early caffeine provides kidney protection in this population.

Who should consider this trial

Good fit: Preterm infants with gestational age under 32 weeks who are admitted to the participating neonatal unit within six hours of birth and do not have major congenital anomalies, severe birth asphyxia, or pre-existing renal anomalies.

Not a fit: Infants with major congenital anomalies, severe birth asphyxia, or known renal malformations are excluded and would not be expected to benefit from this intervention.

Why it matters

Potential benefit: If effective, early caffeine could reduce acute kidney injury and downstream complications such as longer ventilation, prolonged hospitalization, and possibly neonatal mortality.

How similar studies have performed: Observational studies have reported lower AKI rates with early caffeine use, but high-quality randomized comparisons of early caffeine versus supportive care are limited.

Eligibility criteria

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

Where this trial is running

Multan, Punjab Province

• The Children's Hospital & The Institute of Child Health — Multan, Punjab Province, Pakistan (Recruiting)

Study contacts

• Principal investigator: Nazia Fatima, FCPS — The Children's Hospital & The Institute of Child Health, Multan
• Study coordinator: Nazia Fatima, FCPS

Conditions Preterm Birth