Caffeine for Preterm Infants With Apnea of Prematurity(AOP)
Primary Purpose
Caffeine, Apnea of Prematurity
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
80mg/kg of caffeine
20mg/kg of caffeine
Sponsored by
About this trial
This is an interventional treatment trial for Caffeine
Eligibility Criteria
Inclusion Criteria:
- gestational age less than 32 weeks;
- appear AOP;
- parents'consents are obtained.
Exclusion Criteria:
- major congenital abnormalities;
- Parents' rejection
Sites / Locations
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
80mg/kg of caffeine
20mg/kg of caffeine
Arm Description
80mg/kg of caffeine is given to treat AOP.
20mg/kg of caffeine is given to treat AOP.
Outcomes
Primary Outcome Measures
the rate of AOP
AOP appears again in preterm infants
Secondary Outcome Measures
Full Information
NCT ID
NCT03298347
First Posted
September 27, 2017
Last Updated
September 27, 2017
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03298347
Brief Title
Caffeine for Preterm Infants With Apnea of Prematurity(AOP)
Official Title
Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.
Detailed Description
Less evidences about more dose of caffein used in preterm infants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caffeine, Apnea of Prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
80mg/kg of caffeine
Arm Type
Experimental
Arm Description
80mg/kg of caffeine is given to treat AOP.
Arm Title
20mg/kg of caffeine
Arm Type
Active Comparator
Arm Description
20mg/kg of caffeine is given to treat AOP.
Intervention Type
Drug
Intervention Name(s)
80mg/kg of caffeine
Intervention Description
80mg/kg of caffeine is given to treat AOP
Intervention Type
Drug
Intervention Name(s)
20mg/kg of caffeine
Intervention Description
20mg/kg of caffeine is given to treat AOP
Primary Outcome Measure Information:
Title
the rate of AOP
Description
AOP appears again in preterm infants
Time Frame
within 100 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
gestational age less than 32 weeks;
appear AOP;
parents'consents are obtained.
Exclusion Criteria:
major congenital abnormalities;
Parents' rejection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ma Juan, MD
Phone
18680887330
Email
416767068@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shi Yuan, MD;PhD
Phone
13508300283
Email
petshi530@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, MD;PhD
Organizational Affiliation
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD,MD
Phone
13508300283
Email
petshi530@vip.163.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Caffeine for Preterm Infants With Apnea of Prematurity(AOP)
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