Clinical Study of Caffeine for Apnea of Prematurity

NCT01408173 | Completed Phase 3

• 1 other identifier: NPC-11-1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Success rates for controlling of apnea episode in each observation day (at least 50% reduction of apnea episodes from baseline)

  1, 2, 3, 4, 5, 6,7, 8, 9 and 10 day

Secondary Outcomes (5)

• The change of frequency of apnea episode from baseline in each observation day

  1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day

• Time to event：Days until next events occurred

  1 to 10 day

• The change of average duration time of apnea episode from baseline in each observation day

  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

  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

  1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 day

Study Arms (1)

NPC-11

EXPERIMENTAL

* 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.

Interventions

NPC-11 for intravenous or oral administration. DRUG

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

Also known as: caffeine citrate

NPC-11

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (3)

Fujita Health University Hospital

Kutsukake, Aichi-ken, Japan

Location

Osaka Medical Center and Research Institute for Maternal and Child Health

Izumi, Osaka, Japan

Location

Tokyo Metropolitan Children's Medical Center

Fuchū, Tokyo, Japan

Location

MeSH Terms

Conditions

Apnea; Premature Birth

Interventions

Administration, Oral; caffeine citrate

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Susumu Itoh, MD, PhD

  Kagawa University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 3, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

JP (3)