Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

This study is currently recruiting participants.
Verified May 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Lixue, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01866358
First received: May 21, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation


Condition Intervention
Asphyxia Neonatorum
Procedure: Intraosseous infusion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • success rate of resuscitation [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Injury of brain and heart [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Success rate of puncture [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Umbilical vein infusion
Experimental: Intraosseous infusion
using intraosseous infusion for resucitation
Procedure: Intraosseous infusion
Using intraosseous infusion for resustation in this group

  Eligibility

Ages Eligible for Study:   28 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newborns who need resucitation

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866358

Contacts
Contact: Wang Lan, graduate 13650562100 pearl1127@foxmail.com

Locations
China, Chongqing
Pediatrics of Daping Hospital Recruiting
Chongqing, Chongqing, China, 400042
Contact: Wang Lan, graduate    13650562100      
Principal Investigator: Wang Lan, graduate         
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Chair: Shi Yuan, PhD Professor, Chief of Pediatric Department
  More Information

No publications provided

Responsible Party: Lixue, director,head nurse of pediatric department ,principal investigator ,clinical professor, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01866358     History of Changes
Other Study ID Numbers: Wanglan
Study First Received: May 21, 2013
Last Updated: May 28, 2013
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Asphyxia
Asphyxia Neonatorum
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on April 17, 2014