- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866358
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
June 13, 2018 updated by: Lixue, Third Military Medical University
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400042
- Pediatrics of Daping Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 9 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- newborns who need resucitation
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Umbilical vein infusion
using umbilical vein infusion for resucitation
|
Using umbilical vein infusion for resustation in this group
|
EXPERIMENTAL: Intraosseous infusion
using intraosseous infusion for resucitation
|
Using intraosseous infusion for resustation in this group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
success rate of resuscitation
Time Frame: 24 hours
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Injury of brain and heart
Time Frame: 1 month
|
1 month
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success rate of puncture
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Shi Yuan, PhD, Professor, Chief of Pediatric Department
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (ACTUAL)
October 1, 2013
Study Completion (ACTUAL)
May 1, 2014
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
May 28, 2013
First Posted (ESTIMATE)
May 31, 2013
Study Record Updates
Last Update Posted (ACTUAL)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 13, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Wanglan
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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