The aim of the present Phase III study is to evaluate the safety, efficacy and pharmacokinetics of Caffeine Citrate for treatment of apnea of prematurity in Japan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
Fujita Health University Hospital
Kutsukake, Aichi-ken, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan
Tokyo Metropolitan Children's Medical Center
Fuchū, Tokyo, Japan
Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
Time frame: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
The change of frequency of apnea episode from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
Time to event:Days until next events occurred
Time to event:Days until next events occurred. The definition of events are, Not at least 50% reduction of apnea episode Not improving the frequency of episode from baseline Needs mechanical/bag valve mask ventilation.
Time frame: 1 to 10 day
The change of average duration time of apnea episode from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The change of lowest oxygen saturation during apnea episodes from baseline in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
The proportion of less than 85% oxygen saturation during apnea episodes in each observation day
Time frame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
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