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Intraosseous Infusion for Neonatal Asphyxiated Resuscitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lixue, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01866358
First received: May 21, 2013
Last updated: November 13, 2014
Last verified: November 2014
  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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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: November 13, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Asphyxia Neonatorum
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on November 25, 2014