NCT04555915

Brief Summary

In course of the SafeBoosC III trial, we would like to analyse routinely performed GMA as secondary outcome parameter in an ancillary observational study. First aim is to analyse in surviving neonates included into the SafeboosC III trial any differences between the experimental group group and control group in Global-GMA at term age. Second aim is to investigate GMOS at term age and if available GMA at 9-16 weeks corrected age.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

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

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

1.9 years

First QC Date

September 1, 2020

Last Update Submit

July 12, 2022

Conditions

General Movement Assessment

Outcome Measures

Primary Outcomes (1)

  • GMA term age

    General movement assessment

    at term age (gestational age between 37+0 to 42+0 weeks)

Secondary Outcomes (1)

  • GMA 6-9 weeks

    if available optionally at a corrected age between 9 to 16 weeks

Study Arms (2)

Intervention group

Intervention Group of the SafeboosC Phase III Trial

Other: Monitoring of cerebral oxygenation

Control group

Control Group of the SafeboosC Phase III Trial

Interventions

Monitoring of cerebral oxygenationOTHER

Modify cardio-respiratory support to avoid cerebral hypoxia

Intervention group

Eligibility Criteria

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

Neonates will be included, in whom GM assessment is performed routinely at corrected term age or before discharge and optionally at a corrected age between 9 to 16 weeks.

You may qualify if:

  • Signed informed consent

You may not qualify if:

  • Missing written parental informed consent
  • Decision not to conduct full life support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Pediatrics, Medical University of Graz

Graz, Styria, 8036, Austria

Location

Study Officials

  • Gerhard Pichler, MD

    Medical University of Graz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Univ. Prof

Study Record Dates

First Submitted

September 1, 2020

First Posted

September 21, 2020

Study Start

July 1, 2020

Primary Completion

May 31, 2022

Study Completion

May 31, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07

Locations

AU(1)