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

  • China
    • 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
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

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.

Sponsor

Third Military Medical University

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.

Clinical Trials on Asphyxia Neonatorum

Clinical Trials on Umbilical vein infusion

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe