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Infant Special Program for In Hospital Resuscitation Education in the Delivery Room (INSPIRE-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02347241
Recruitment Status : Completed
First Posted : January 27, 2015
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
Theresa Mariero Olasveengen, Oslo University Hospital

Brief Summary:
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.

Condition or disease Intervention/treatment Phase
Hypoxia, in Liveborn Infant Neonatal Asphyxia Neonatal Bradycardia Other: Educational intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 435 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Infant Special Program for In Hospital Resuscitation Education in the Delivery Room - INSPIRE-D
Study Start Date : January 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control period
Assessment of resuscitation quality and clinical outcomes prior to educational intervention
Experimental: Educational intervention
Assessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.
Other: Educational intervention
Educational Debriefings and High frequency training and team reflection




Primary Outcome Measures :
  1. Quality of neonatal resuscitation (Validated performance score assessed by video analysis) [ Time Frame: 12 months ]
    Validated performance score assessed by video analysis


Secondary Outcome Measures :
  1. Clinical outcome - Time to effective respiration [ Time Frame: 12 months ]
  2. Clinical outcome - Time to heart rate > 100 [ Time Frame: 12 months ]
  3. Clinical outcome - Admission to intensive care [ Time Frame: 12 months ]
  4. Health care providers adherence to guidelines and behaviour markers - Self-reported score [ Time Frame: 12 months ]
  5. Health care providers adherence to guidelines and behaviour markers - Simulation score [ Time Frame: 12 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Neonates that require stabilisation and/or resuscitation such as ventilatory support, medications and/or chest compressions.

Exclusion Criteria:

  • Parent or health care provider reserved against study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347241


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0405
Sponsors and Collaborators
Oslo University Hospital
Investigators
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Principal Investigator: Theresa M Olasveengen, MD PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Theresa Mariero Olasveengen, Researcher, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02347241    
Other Study ID Numbers: 2013/12769
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
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Bradycardia
Asphyxia Neonatorum
Hypoxia
Asphyxia
Signs and Symptoms, Respiratory
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death
Wounds and Injuries
Infant, Newborn, Diseases