at Orange, California
study started
completion around
Principal Investigator
by Cherry Uy, MD



This study aims to assess whether extending the duration of caffeine therapy will help preterm infants achieve full oral feeding faster.


This study is a randomized, double-blinded, placebo-controlled trial. Infants will be randomized to receive either caffeine or placebo for up to maximum of four additional weeks after meeting clinical criteria to discontinue caffeine. Initiation of oral feeding will be based on standard of care as determined by a neonatal occupational therapist and clinical cues. Oral feedings will be advanced by a standardized 5 step oral feeding protocol. The time it takes to achieve full oral feeds between the treatment and control groups will be compared.


Apnea of Prematurity, Feeding, Caffeine, Premature Birth


You can join if…

• Infants born at equal to or less than 32 weeks and 0 days gestational age AND

  • Equal to or greater than 34 weeks and 0 days corrected gestation at time of enrollment.
  • Off respiratory support for at least 1 week (nasal canula oxygen, high flow nasal canula, continuous positive airway pressure (CPAP), mechanical ventilation).
  • On caffeine and meet criteria to discontinue caffeine.
  • No significant cardiopulmonary events for at least 5 days (apnea > 20 seconds, apnea with heart rate (HR) < 80 beats per minute (bpm), HR < 80 bpm with desaturation < 85% or color change).

You CAN'T join if...

  • Infants with critical congenital heart disease.
  • Infants with neuromuscular conditions affecting respiration.
  • Infants with overt brain injury (i.e. severe Grade 3-4 intraventricular hemorrhage, cystic periventricular leukomalacia) that may affect oral feeding.
  • Infants with major genetic disorders.
  • Infants with anatomic anomalies that will hinder oral feeding.
  • Infants who have already progressed to Step 3 (of 5) of our institution's oral feeding protocol (oral feeds 4 times per day).
  • Infants who develop necrotizing enterocolitis after enrollment.
  • Failure to obtain consent or declined by parents.


  • UC Irvine Medical Center accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Cherry Uy, MD
    Health Sciences Professor, Pediatrics, School of Medicine. Authored (or co-authored) 14 research publications


accepting new patients
Start Date
Completion Date
University of California, Irvine
Phase 2 research study
Study Type
Expecting 40 study participants
Last Updated