NCT01193751

Brief Summary

The specified Apgar-Score in combination with the AAP-Score predicts the morbidity and mortality of asphyxiated newborns.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2010

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 18, 2011

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

September 1, 2010

Last Update Submit

February 17, 2011

Conditions

Keywords

Birth AsphyxiaNewborn's ResuscitationDeathNeurodevelopmental Impairment

Outcome Measures

Primary Outcomes (1)

  • Death or Neurologic impairment

    2 years

Study Arms (1)

asphyxiated newborns > 37 weeks of gestation

Eligibility Criteria

Age37 Weeks+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Asphyxiated newborns \>37 weeks of gestation receiving resuscitative interventions

You may qualify if:

  • Parental consent
  • Born within the study center (inborn)
  • gestational age \>37 completed weeks
  • Receiving one or more resuscitive intervention (CPAP, Oxygen supplementation, Intubation and ventilation, bag and mask ventilation, surfactant, catecholamines, chest compression) and/or Birth Asphyxia with a umbilical artery pH \<7,0 or BE \> -16 with subsequent admission to NICU.

You may not qualify if:

  • missing parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dresden University of Technology, Department of Neonatology

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

DeathAsphyxia Neonatorum

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2010

First Posted

September 2, 2010

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 18, 2011

Record last verified: 2010-09

Locations