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Completed

NCT Number: NCT01530360

Cerebral Oxygenation to Guide Medical Interventions in Extremely Preterm Infants

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.

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Key information

Conditions

Premature Infants Female Urogenital Diseases and Pregnancy Complications Near-Infrared Spectroscopy Obstetric Labor Complications Obstetric Labor, Premature Oximetry Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 3 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Neonatology, Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • decision not to provide full life support

Treatment and study plan

cerebral oximeter

Device

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

Primary outcomes

  1. change of medical management elicited by cerebral oxygenation out of range

    Time frame: 0-72 hours of life

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

Secondary outcomes

  1. Adverse device effects

    Time frame: 0-72 hours

    Expected and unexpected

  2. burden of hypo-and hyperoxia

    Time frame: 0-72 hours

    measured as %hours out of the target range (55-85%)

Sponsors and collaborators

Lead sponsor

Gorm Greisen

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • Elsass Foundation
  • Hospices Civils de Lyon
  • Hospital Universitario La Paz
  • KU Leuven
  • Medical University of Graz
  • Universitair Medisch Centrum Utrecht
  • University College Cork
  • University of Milan
  • University of Witten/Herdecke
  • University of Zurich
  • Uppsala University

Registry information

Official study title

Safeguarding the Brains of Our Smallest Children - a Pilot Study

Acronym: SafeBoosC-p

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Feb 9, 2012
Registry last updated
Dec 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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