Status:

NOT_YET_RECRUITING

Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

Lead Sponsor:

University of Rochester

Conditions:

Neonatal Apnea

Infants

Eligibility:

All Genders

Up to 27 years

Phase:

PHASE2

Brief Summary

The goal of this clinical trial is to determine whether a higher dose of caffeine citrate can improve breathing and reduce health complications in extremely premature infants, specifically those born ...

Eligibility Criteria

Inclusion

  • URMC Inborn Newborn infants born with gestational age of 22 weeks 0 days - 27 weeks 6 days or infants OR ≥ 28 weeks with a birthweight \< 1000 grams

Exclusion

  • Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congenital or genetic anomalies, infants not anticipated to survive beyond 72 hours, infants with mothers that are non-English speaking or \<18 years old at time of enrollment.

Key Trial Info

Start Date :

November 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT07216365

Start Date

November 1 2025

End Date

September 1 2027

Last Update

October 14 2025

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