Caffeine Optimization for Oxygen Saturation Index in ELBW Infants

Recruiting Phase 2 Interventional Study
Neonatal Apnea Infants
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
0 Days – 27 Weeks
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Rochester · Other
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About This Trial
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 before 28 weeks of pregnancy, known as ELGAN infants. These babies often struggle with breathing due to underdeveloped lungs, and caffeine is commonly used to help support their respiratory function. …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Hepatic failure, spontaneous intestinal perforation, necrotizing enterocolitis, Anticipated major congen…
Contacts

Stephanie C Vachon, DO

(585) 275-4174

stephanie_vachon@urmc.rochester.edu

CONTACT