Caffeine Use in the Management of Preterm Infants

a study on Apnea of Prematurity Premature Birth

Summary

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

Description

Summary

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

Details

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.

Keywords

Apnea of Prematurity, Feeding, Caffeine, Premature Birth

Eligibility

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 2 days (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.

Location

  • 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) 15 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Irvine
ID
NCT06327152
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 40 study participants
Last Updated
Contact us about this trial