Intraosseous Infusion for Neonatal Asphyxiated Resuscitation | NCT01866358

Studies
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

NCT01866358

Sponsor

Third Military Medical University

Status

Completed

Last Update Posted

Jun 15, 2018Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Asphyxia Neonatorum

Interventions

Intraosseous infusion
Umbilical vein infusion

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Oct 2013Actual

Completion Date

May 2014Actual

First Submitted Date

May 21, 2013

First Submission Date that Met QC Criteria

May 28, 2013

First Posted Date

May 31, 2013Estimated

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

Jun 13, 2018

Last Update Posted Date

Jun 15, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lixue, director，head nurse of pediatric department ，principal investigator ，clinical professor, Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Third Military Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Umbilical vein infusion	Placebo Comparator	using umbilical vein infusion for resucitation	Procedure: Umbilical vein infusion
Intraosseous infusion	Experimental	using intraosseous infusion for resucitation	Procedure: Intraosseous infusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intraosseous infusion	Procedure	Using intraosseous infusion for resustation in this group	Intraosseous infusion

Measure	Description	Time Frame
success rate of resuscitation		24 hours

Measure	Description	Time Frame
Injury of brain and heart		1 month

Measure	Description	Time Frame
Success rate of puncture		24 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborns who need resucitation

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Weeks

Maximum Age

42 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shi Yuan, PhD	Professor, Chief of Pediatric Department	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pediatrics of Daping Hospital		Chongqing	Chongqing Municipality	400042	China

Condition Browse Module

MeSH Terms

ID	Term
D001238	Asphyxia Neonatorum

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017148	Infusions, Intraosseous

Ancestor Terms

ID	Term
D007263	Infusions, Parenteral
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided