NCT01866358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

May 21, 2013

Last Update Submit

June 13, 2018

Conditions

Asphyxia Neonatorum

Outcome Measures

Primary Outcomes (1)

  • success rate of resuscitation

    24 hours

Secondary Outcomes (1)

  • Injury of brain and heart

    1 month

Other Outcomes (1)

  • Success rate of puncture

    24 hours

Study Arms (2)

Umbilical vein infusion

PLACEBO COMPARATOR

using umbilical vein infusion for resucitation

Procedure: Umbilical vein infusion

Intraosseous infusion

EXPERIMENTAL

using intraosseous infusion for resucitation

Procedure: Intraosseous infusion

Interventions

Intraosseous infusionPROCEDURE

Using intraosseous infusion for resustation in this group

Intraosseous infusion
Umbilical vein infusionPROCEDURE

Using umbilical vein infusion for resustation in this group

Umbilical vein infusion

Eligibility Criteria

Age28 Weeks - 42 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • newborns who need resucitation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatrics of Daping Hospital

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Infusions, Intraosseous

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Infusions, ParenteralDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Shi Yuan, PhD

    Professor, Chief of Pediatric Department

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director，head nurse of pediatric department ，principal investigator ，clinical professor

Study Record Dates

First Submitted

May 21, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

CN(1)