Clinical trial NCT01408173: Clinical Study of Caffeine for Apnea of Prematurity
Official title: A Phase III Clinical Study of NPC-11 in the Treatment of Apnea of Prematurity. - Investigation of Safety, Efficacy and Pharmacokinetics of Caffeine Citrate -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Apnea of Prematurity
Keywords: caffeine
apnea
prematurity
Lead sponsor: Nobelpharma
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 28
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Postconceptional age between 28 weeks and 33 weeks, and over 24 hours after birth.
* At least 6 episodes of apnea (\>20 seconds in duration) in 24 hours.
* Signed written informed consent from parent(s) or legal guardian(s).

Exclusion Criteria:

* Apnea due to: hypoxic-ischemic encephalopathy, meningitis, seizures, Grade III or IV intracranial hemorrhage, CNS depression from drugs administered to the mother during delivery, periventricular leukomalacia, pneumonia which does not improve even if it treats, hemoglobin\< 10 g/dL, sepsis, shock which does not improve even if it treats, blood pH\<7.2 on 2 consecutive determinations in spite of correction, serum calcium concentration \<7.0 mg/dL which does not improve even if it treats, serum glucose concentration \<4.0 mg/dL which does not improve even if it treats, congestive heart failure, symptomatic patent ductus arteriosus, rectal temperature\>38.5 °C on 2 consecutive readings, rectal temperature\< 35 °C on 2 consecutive readings, obstructive apnea.
* Blood urea nitrogen \>20 mg/dL, serum creatinine \>1.5 mg/dL.
* Serum AST or ALT \>3 times the upper limit of normal.
* Requirement of mechanically-assisted ventilation ( containing nasal CPAP, nasal DPAP).
* Previous treatment with methylxanthines within 7 days prior to study enrollment.
* Previous treatment with H2 antagonists (i.e., cimetidine or ranitidine) within 7 days prior to study enrollment.
* Receiving or experiencing the effects of CNS-active medication at the time of enrollment.
* Participant of other clinical trial within 6 months.
* Inappropriate to enter this clinical trial judged by the investigator in charge.

Primary outcomes:
measure: Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)
timeFrame: 1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day
Secondary outcomes:
measure: The change of frequency of apnea episode from baseline in each observation day
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
measure: Time to event：Days until next events occurred
timeFrame: 1 to 10 day
measure: The change of average duration time of apnea episode from baseline in each observation day
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
measure: The change of lowest oxygen saturation during apnea episodes from baseline in each observation day
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
measure: The proportion of less than 85% oxygen saturation during apnea episodes in each observation day
timeFrame: 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day
Other outcomes:
Locations:
city: Kutsukake
country: Japan
facility: Fujita Health University Hospital
state: Aichi
city: Izumi
country: Japan
facility: Osaka Medical Center and Research Institute for Maternal and Child Health
state: Osaka
city: Fuchu
country: Japan
facility: Tokyo Metropolitan Children's Medical Center
state: Tokyo
Study officials:
affiliation: Kagawa University
name: Susumu Itoh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: