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Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01866358
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Lixue, Third Military Medical University

Brief Summary:
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation

Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Procedure: Intraosseous infusion Procedure: Umbilical vein infusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
Study Start Date : May 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Umbilical vein infusion
using umbilical vein infusion for resucitation
Procedure: Umbilical vein infusion
Using umbilical vein infusion for resustation in this group

Experimental: Intraosseous infusion
using intraosseous infusion for resucitation
Procedure: Intraosseous infusion
Using intraosseous infusion for resustation in this group




Primary Outcome Measures :
  1. success rate of resuscitation [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Injury of brain and heart [ Time Frame: 1 month ]

Other Outcome Measures:
  1. Success rate of puncture [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newborns who need resucitation

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866358


Locations
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China, Chongqing
Pediatrics of Daping Hospital
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University
Investigators
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Study Chair: Shi Yuan, PhD Professor, Chief of Pediatric Department
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Responsible Party: Lixue, director,head nurse of pediatric department ,principal investigator ,clinical professor, Third Military Medical University
ClinicalTrials.gov Identifier: NCT01866358    
Other Study ID Numbers: Wanglan
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases