NCT01530360

Brief Summary

Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

3 months

First QC Date

February 7, 2012

Last Update Submit

December 7, 2012

Conditions

Premature InfantsNear-infrared SpectroscopyOximetry

Outcome Measures

Primary Outcomes (1)

  • change of medical management elicited by cerebral oxygenation out of range

    Recording of the type of change of management as defined by the treatment guideline

    0-72 hours of life

Secondary Outcomes (2)

  • Adverse device effects

    0-72 hours

  • burden of hypo-and hyperoxia

    0-72 hours

Study Arms (1)

cerebral oximetry + treatment guideline

EXPERIMENTAL

Cerebral oximetry applied as soon as possible after birth and continued until 72 hours of life Clinical staff administer the routine medical management according to local practice as well as respond to out-of-range values with the help of the treatment guideline

Device: cerebral oximeter

Interventions

cerebral oximeterDEVICE

INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA

cerebral oximetry + treatment guideline

Eligibility Criteria

AgeUp to 3 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • gestational age at birth less than 28 completed weeks
  • cerebral oximeter in place at 3 hours after birth

You may not qualify if:

  • decision not to provide full life support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Greisen G, Leung T, Wolf M. Has the time come to use near-infrared spectroscopy as a routine clinical tool in preterm infants undergoing intensive care? Philos Trans A Math Phys Eng Sci. 2011 Nov 28;369(1955):4440-51. doi: 10.1098/rsta.2011.0261.

    PMID: 22006900BACKGROUND

  • Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM, Fumagalli M, Gluud C, Hagmann C, Hellstrom-Westas L, Lemmers P, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Stoy LS, Wolf M, Greisen G. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Dan Med J. 2013 Jan;60(1):A4533.

    PMID: 23340184DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Gorm Greisen, MD,DMSci

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor,head of department

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

DK(1)