Clinical Study of Caffeine for Apnea of Prematurity

NCT ID: NCT01408173

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-10-31

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.

Conditions

Apnea of Prematurity

Keywords

caffeine; apnea; prematurity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NPC-11 for intravenous or oral administration.

Intervention Type: DRUG

NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).

Interventions

NPC-11 for intravenous or oral administration.

NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).

Intervention Type: DRUG

Other Intervention Names

caffeine citrate

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.

• Minimum Eligible Age: 28 Weeks
• Maximum Eligible Age: 33 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susumu Itoh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kagawa University

Locations

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

Countries

Japan

Other Identifiers

NPC-11-1

Identifier Type: -

Identifier Source: org_study_id