Back to resultsIntraosseous Infusion for Neonatal Asphyxiated Resuscitation
Primary Purpose
Asphyxia Neonatorum
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intraosseous infusion
Umbilical vein infusion
Sponsored by
About this trial
This is an interventional supportive care trial for Asphyxia Neonatorum
Eligibility Criteria
Inclusion Criteria:
- newborns who need resucitation
Exclusion Criteria:
-
Sites / Locations
- Pediatrics of Daping Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Umbilical vein infusion
Intraosseous infusion
Arm Description
using umbilical vein infusion for resucitation
using intraosseous infusion for resucitation
Outcomes
Primary Outcome Measures
success rate of resuscitation
Secondary Outcome Measures
Injury of brain and heart
Full Information
NCT ID
NCT01866358
First Posted
May 21, 2013
Last Updated
June 13, 2018
Sponsor
Third Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01866358
Brief Title
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Official Title
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Umbilical vein infusion
Arm Type
Placebo Comparator
Arm Description
using umbilical vein infusion for resucitation
Arm Title
Intraosseous infusion
Arm Type
Experimental
Arm Description
using intraosseous infusion for resucitation
Intervention Type
Procedure
Intervention Name(s)
Intraosseous infusion
Intervention Description
Using intraosseous infusion for resustation in this group
Intervention Type
Procedure
Intervention Name(s)
Umbilical vein infusion
Intervention Description
Using umbilical vein infusion for resustation in this group
Primary Outcome Measure Information:
Title
success rate of resuscitation
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Injury of brain and heart
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Success rate of puncture
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
newborns who need resucitation
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi Yuan, PhD
Organizational Affiliation
Professor, Chief of Pediatric Department
Official's Role
Study Chair
Facility Information:
Facility Name
Pediatrics of Daping Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
12. IPD Sharing Statement
Learn more about this trial
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
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