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Clinical Study of Caffeine for Apnea of Prematurity

Primary Purpose

Apnea of Prematurity

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
NPC-11 for intravenous or oral administration.
Sponsored by
Nobelpharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea of Prematurity focused on measuring caffeine, apnea, prematurity

Eligibility Criteria

28 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fujita Health University Hospital
  • Osaka Medical Center and Research Institute for Maternal and Child Health
  • Tokyo Metropolitan Children's Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NPC-11

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The change of frequency of apnea episode from baseline in each observation 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.
The change of average duration time of apnea episode from baseline in each observation day
The change of lowest oxygen saturation during apnea episodes from baseline in each observation day
The proportion of less than 85% oxygen saturation during apnea episodes in each observation day

Full Information

First Posted
July 29, 2011
Last Updated
October 29, 2013
Sponsor
Nobelpharma
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1. Study Identification

Unique Protocol Identification Number
NCT01408173
Brief Title
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

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nobelpharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea of Prematurity
Keywords
caffeine, apnea, prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NPC-11
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NPC-11 for intravenous or oral administration.
Other Intervention Name(s)
caffeine citrate
Intervention Description
NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
Time to event：Days until next events occurred
Description
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susumu Itoh, MD, PhD
Organizational Affiliation
Kagawa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujita Health University Hospital
City
Kutsukake
State/Province
Aichi
Country
Japan
Facility Name
Osaka Medical Center and Research Institute for Maternal and Child Health
City
Izumi
State/Province
Osaka
Country
Japan
Facility Name
Tokyo Metropolitan Children's Medical Center
City
Fuchu
State/Province
Tokyo
Country
Japan

12. IPD Sharing Statement

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Clinical Study of Caffeine for Apnea of Prematurity

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