Caffeine for Preterm Infants With Apnea of Prematurity(AOP) | NCT03298347

Studies
Caffeine for Preterm Infants With Apnea of Prematurity(AOP)

NCT03298347

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Unknown status

Last Update Posted

Oct 2, 2017Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Caffeine
Apnea of Prematurity

Interventions

80mg/kg of caffeine
20mg/kg of caffeine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2017Estimated

Primary Completion Date

Oct 1, 2018Estimated

Completion Date

Oct 1, 2018Estimated

First Submitted Date

Sep 27, 2017

First Submission Date that Met QC Criteria

Sep 27, 2017

First Posted Date

Oct 2, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 27, 2017

Last Update Posted Date

Oct 2, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma Juan, Director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
80mg/kg of caffeine	Experimental	80mg/kg of caffeine is given to treat AOP.	Drug: 80mg/kg of caffeine
20mg/kg of caffeine	Active Comparator	20mg/kg of caffeine is given to treat AOP.	Drug: 20mg/kg of caffeine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
80mg/kg of caffeine	Drug	80mg/kg of caffeine is given to treat AOP	80mg/kg of caffeine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the rate of AOP	AOP appears again in preterm infants	within 100 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

gestational age less than 32 weeks;
appear AOP;
parents'consents are obtained.

Exclusion Criteria:

major congenital abnormalities;
Parents' rejection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Month

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Juan, MD	Contact	18680887330		416767068@qq.com
Shi Yuan, MD;PhD	Contact	13508300283		petshi530@vip.163.com

Overall Officials

Name	Affiliation	Role
Shi Yuan, MD;PhD	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University	Recruiting	Chongqing	Chongqing Municipality	400042	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001049	Apnea

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002110	Caffeine

Ancestor Terms

ID	Term
D014970	Xanthines
D000470	Alkaloids
D006571	Heterocyclic Compounds
D011688	Purinones

Browse Leaves

Not provided

Browse Branches

Not provided