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Clinical Trials/NCT02347241
NCT02347241CompletedNot Applicable

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

Oslo University Hospital2 sites in 1 country435 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
435
Locations
2
Primary Endpoint
Quality of neonatal resuscitation (Validated performance score assessed by video analysis)

Study Overview

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.

Detailed Description

This prospective interventional trial will be conducted in the delivery unit at OUS. The planned studies consist of five distinct phases with step-wise interventions; 1) baseline data collection, 2) introducing educational debriefing, 3) intensive run-in/rolling-refresher phase, 4) INSPIRE-D phase and lastly 5) evaluation phase.

Phase 1: The baseline data collection phase

  1. Needs assessment/questionnaires from participating healthcare providers will be collected which include demographic data such as sex, age, education, and work experience, as well as exposure to resuscitation training, simulation, self-perceived confidence and suggestions for further training/educational topics.
  2. Observations of the newborn in the resuscitation bays will be done by video recordings and supplemented by resuscitation records, hospital quality improvement data and medical records. Data points to be collected of the newborn are demographics, gestational age, physiological parameters such as heart rate and respirations/oxygenation, Apgar score, interventions performed, and outcomes during and at discharge from hospital.
  3. The healthcare providers adherence to guidelines in neonatal resuscitation (both technical and non-technical skills like team collaboration) will be evaluated by examining the video recordings and scored by validated scoring systems formerly tested with good intra- and inter-rater reliability. The scoring systems is adapted to guidelines from the Norwegian Council of Resuscitation and retested for intra- and inter-rater reliability.

Phase 2: Intervention Phase with Educational Debriefings

  1. Educational debriefings of healthcare providers involved in clinical situations with newborn resuscitation: Selected resuscitation events will be debriefed facilitated by a study team member with special competence in facilitation and an instructor in neonatal resuscitation. The debriefing will be held depending on clinical schedule and availability, to discuss process of care, performance, and provide education to multidisciplinary staff with advocacy/inquiry debriefing techniques.
  2. For healthcare providers; cont¬inued needs assessment and prospective observations by video-recordings in resuscitation bays to document quality of care.
  3. Baseline skills assessment will be collected using a novel manikin, the Newborn Lung Simulator. Healthcare providers will be presented for a mini-simulation with a compromised newborn and asked to perform high quality resuscitation. The performance and adherence to guidelines will be evaluated and retested after the intervention.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Quality of neonatal resuscitation (Validated performance score assessed by video analysis)

Time Frame: 12 months

Validated performance score assessed by video analysis

Secondary Outcomes

  • Health care providers adherence to guidelines and behaviour markers - Self-reported score(12 months)
  • Health care providers adherence to guidelines and behaviour markers - Simulation score(12 months)
  • Clinical outcome - Time to effective respiration(12 months)
  • Clinical outcome - Time to heart rate > 100(12 months)
  • Clinical outcome - Admission to intensive care(12 months)

Investigators

Sponsor
Oslo University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Theresa Mariero Olasveengen

Researcher

Oslo University Hospital

Study Sites (2)

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