Target Weaning Oxygen to Determine Cafffeine Duration for AOP
Status:
Recruiting
Trial end date:
2022-04-30
Target enrollment:
Participant gender:
Summary
Caffeine, a typical representative of methylxanthine, is world-widely used to manage apnea of
prematurity (AOP) in neonatology. However, an appropriate medication regimen of caffeine has
not been well defined until now. For example, in terms of the duration of caffeine, AAP
guideline for AOP (2016) and British NICE guideline for neonatal respiratory care (2019) all
recommended discontinuing caffeine when the infants reached a postmenstrual age (PMA)
≥33weeks and had a stable respiratory status, commonly manifested by weaning from
non-invasive ventilation and free of apneic episodes for at least five consecutive days.
Interestingly, the actual clinical settings seem to be not strictly following this
recommendation. A survey of the neonatologist in North America revealed that a substantial
variability existed among sites in the timing of caffeine discontinuation before discharge
and the respiratory support at the time of caffeine discontinuation [1]. Another survey in
Saudi Arabia also had a similar finding [2]. The optimal timing of discontinuing caffeine is
still a conundrum in the field of neonatology.
Ideally, the optimal timing of discontinuing caffeine should be individual-specific.
Published work has indicated that AOP and intermittent hypoxemia (IH) were frequently
observed beyond 36 weeks' PMA in all gestational age groups, particularly in the 24- to
27-week infants [3, 4]. In the clinical settings, intermittent hypoxic and AOP episodes is a
predominant cause of oxygen supplement in premature infants and commonly prolong the hospital
stay. Optimizing arterial saturation by oxygen supplement is essential to achieve a stable
cardiorespiratory status because hypoxemia could induce hypoxic sensitivity of the carotid
bodies in neonates, resulting in more pronounced ventilatory depression and more frequent
apneic episodes. Some RCTs have shown that continuing caffeine administration beyond PMA 34
weeks could reduce the frequency of IH episodes in premature infants [4, 5]. Therefore,
theoretically, a prolonged caffeine administration over the usual duration could shorten the
duration of oxygen supplements in those infants at high risk of frequent late AOP or IH.
Target weaning oxygen could be an opportunistic indicator of discontinuing caffeine.
In light of the above considerations, a multicenter, retrospective, partially blinded,
controlled trials will be conducted to verify the hypothesis that a novel caffeine regimen
that weaning oxygen as the indicator of discontinuing caffeine could improve respiratory
outcomes of very premature infants.
Phase:
Phase 4
Details
Lead Sponsor:
Children's Hospital of Chongqing Medical University