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Trial record 5 of 53 for:    "Asphyxia neonatorum"

Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01866358
First Posted: May 31, 2013
Last Update Posted: November 17, 2014
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.
Information provided by (Responsible Party):
Lixue, Third Military Medical University
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Lixue, Third Military Medical University:

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

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

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

Enrollment: 60
Study Start Date: May 2013
Study Completion Date: May 2014
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

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:

  Contacts and Locations
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
China, Chongqing
Pediatrics of Daping Hospital
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Chair: Shi Yuan, PhD Professor, Chief of Pediatric Department
  More Information

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
First Submitted: May 21, 2013
First Posted: May 31, 2013
Last Update Posted: November 17, 2014
Last Verified: November 2014

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