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. 2024 Jul 24;2024(7):CD015802. doi: 10.1002/14651858.CD015802.pub2

NCT04868565.

Study name Target weaning oxygen to determine caffeine duration for AOP (DCAP)
Methods Multicenter, prospective, randomized controlled trial
Participants Inclusion criteria:
  • Premature infants with gestational age < 30 weeks;

  • Postmenstrual age ≥ 32weeks

  • A history of caffeine therapy

  • No current positive pressure respiratory support, and free of apnea for at least five consecutive days, but still oxygen dependent

  • Parents or legal guardians sign informed consent to attend this study


Exclusion criteria:
  • Congenital cardiorespiratory malformation, or chromosomal abnormalities

  • Grade III/IV intraventricular hemorrhage, or probable brain injury attributable to confirmed central nervous system infection, severe periventricular leukomalacia or other entities

  • Underwent tracheostomy

  • Currently on sedatives, opioids, or other medication related to depressed breath

Interventions Samples assigned to the "ongoing caffeine with oxygen supplement (group 1)" will continue caffeine administration combined with oxygen supplement until the patients are weaned from oxygen.
Samples assigned to the "discontinuing caffeine with oxygen supplement (group 2)" will discontinue caffeine immediately after randomization, while oxygen supplement is going on
Outcomes Primary outcomes:
  • RAP

  • Duration of oxygen supplement after randomization

  • Duration of hospital stay after randomization


Secondary outcomes:
  • Postmenstrual age of discharging home

  • Onset of bronchopulmonary dysplasia

  • Severity of bronchopulmonary dysplasia

  • Restart caffeine therapy

  • Restart noninvasive ventilation

  • Reintubation of patients

  • Hospitalization cost after randomization

Starting date 5 January 2021
Contact information Name: Jianhui Wang
Phone Number: +86‐13678428167
Email: wangjh@cqmu.edu.cn
Comparison  
Notes Estimated primary completion date 31 October 2023

AOP: apnea of prematurity; BPD: Bronchopulmonary dysplasia; BID: twice a day; CPAP: continuous positive airway pressure; IH: intermittent hypoxemia; MRI: Magnetic Resonance Imaging; NICHD: National Institute of Child Health and Human Development; NICU: Neonatal intensive care unit; NPO: nothing per mouth; NRN: Neonatal Research Network; PMA: postmenstrual age; RAP: recurrence of apnea of prematurity.