Clinical Study of Caffeine for Apnea of Prematurity

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Apnea of Prematurity	Drug: NPC-11 for intravenous or oral administration.	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	August 2011
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Arm

Intervention/treatment

Experimental: NPC-11; Loading Dose (Day 1): Caffeine citrate 20 mg/kg body weight will be administered intravenously using a syringe infusion pump over 30 minutes.; Maintenance Dose (Day 2～Day 10): After an interval 24 hours, caffeine citrate 5 mg/kg body weight will be administered intravenously (over 10 minutes) or orally if the patients will be able to receive oral administration once a day. The maintenance dose can be increased to a maximum 10 mg/kg caffeine citrate once a day if apnea persists.

Drug: NPC-11 for intravenous or oral administration.; NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).; Other Name: caffeine citrate

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. Time to event：Days until next events occurred [ Time Frame: 1 to 10 day ]

   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.

3. 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 ]
4. 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 ]
5. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	28 Weeks to 33 Weeks (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Japan
Fujita Health University Hospital
Kutsukake, Aichi, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health
Izumi, Osaka, Japan
Tokyo Metropolitan Children's Medical Center
Fuchu, Tokyo, Japan

Sponsors and Collaborators

Nobelpharma

Investigators

Principal Investigator:	Susumu Itoh, MD, PhD	Kagawa University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nobelpharma
ClinicalTrials.gov Identifier:	NCT01408173 History of Changes
Other Study ID Numbers:	NPC-11-1
First Posted:	August 3, 2011
Last Update Posted:	October 30, 2013
Last Verified:	October 2013

Keywords provided by Nobelpharma:

caffeine; apnea; prematurity

Additional relevant MeSH terms:

Apnea; Premature Birth; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Citric Acid; Caffeine; Caffeine citrate; Anticoagulants	Calcium Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Stimulants; Physiological Effects of Drugs; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Purinergic P1 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Neurotransmitter Agents