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

Primary Purpose

Hypoxia, in Liveborn Infant, Neonatal Asphyxia, Neonatal Bradycardia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Educational intervention
Sponsored by
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypoxia, in Liveborn Infant

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control period

Educational intervention

Arm Description

Assessment of resuscitation quality and clinical outcomes prior to educational intervention

Assessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 12, 2015
Last Updated
September 30, 2016
Sponsor
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02347241
Brief Title
Infant Special Program for In Hospital Resuscitation Education in the Delivery Room
Acronym
INSPIRE-D
Official Title
Infant Special Program for In Hospital Resuscitation Education in the Delivery Room - INSPIRE-D
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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. 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. 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 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. For healthcare providers; cont¬inued needs assessment and prospective observations by video-recordings in resuscitation bays to document quality of care. 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. Phase 3 - Intensive run-in of high frequency training and team reflection: "The rolling refresher phase" In this phase training triggers are identified at the start of each day shift. A careful consideration of perinatal factors of both mother and infant will identify "high risk" deliveries with babies who may need resuscitation. If no risk deliveries are identified, a random Healthcare Provider team among the present staff will be selected. "Just-in-time" and "just-in-place" training; the novel "Rolling refresher", will be introduced (target >80% of staff) at the beginning of day shifts. Health Care Providers caring for labouring mothers with training triggers will be identified and exposed to "low dose" simulation-based "just-in-time" and "just-in-place" skills training. The short training session (<10 minutes) will take place on-site in the resuscitation bay with relevant topics such as; timely assessment of need for intervention, effective assisted ventilations on a Newborn Lung Simulator. We will use observations from the video-films to target training with focus on rapid evaluation of respiratory distress, correct ventilation technique and use of pulse oximetry. Continued simulation training will be based on problem areas identified from baseline. Performance during simulation training will be evaluated and registered. Educational debriefings will continue, as in Phase 2 Continued needs assessment and prospective observations in resuscitation bays to document provider confidence, simulation performance and quality of care during implementation of the INSPIRE-D bundle described above. Phase 4: Continued INSPIRE-D bundle. After successful implementation defined as >80% of staff having been through at least one "just-in-time and just in place" training session, all interventions above (phase 2 and 3) will continue on routine basis. Continued needs assessment of confidence and performance are repeated as described above. Phase 5: Evaluation. Evaluation of the INSPIRE-D bundle to identify and define key factors and processes that we prove necessary to ensure timely and effective neonatal resuscitation associated with improved newly born survival and neurologic outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia, in Liveborn Infant, Neonatal Asphyxia, Neonatal Bradycardia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
435 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control period
Arm Type
No Intervention
Arm Description
Assessment of resuscitation quality and clinical outcomes prior to educational intervention
Arm Title
Educational intervention
Arm Type
Experimental
Arm Description
Assessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.
Intervention Type
Other
Intervention Name(s)
Educational intervention
Intervention Description
Educational Debriefings and High frequency training and team reflection
Primary Outcome Measure Information:
Title
Quality of neonatal resuscitation (Validated performance score assessed by video analysis)
Description
Validated performance score assessed by video analysis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Clinical outcome - Time to effective respiration
Time Frame
12 months
Title
Clinical outcome - Time to heart rate > 100
Time Frame
12 months
Title
Clinical outcome - Admission to intensive care
Time Frame
12 months
Title
Health care providers adherence to guidelines and behaviour markers - Self-reported score
Time Frame
12 months
Title
Health care providers adherence to guidelines and behaviour markers - Simulation score
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa M Olasveengen, MD PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0405
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
34223356
Citation
Niles DE, Skare C, Foglia EE, Insley E, Cines C, Olasveengen T, Ballester LS, Ades A, Posencheg M, Nadkarni VM, Kramer-Johansen J. Effect of a positive pressure ventilation-refresher program on ventilation skill performance during simulated newborn resuscitation. Resusc Plus. 2021 Feb 16;5:100091. doi: 10.1016/j.resplu.2021.100091. eCollection 2021 Mar.
Results Reference
derived
PubMed Identifier
30009926
Citation
Skare C, Boldingh AM, Kramer-Johansen J, Calisch TE, Nakstad B, Nadkarni V, Olasveengen TM, Niles DE. Video performance-debriefings and ventilation-refreshers improve quality of neonatal resuscitation. Resuscitation. 2018 Nov;132:140-146. doi: 10.1016/j.resuscitation.2018.07.013. Epub 2018 Jul 18.
Results Reference
derived
PubMed Identifier
27496260
Citation
Skare C, Boldingh AM, Nakstad B, Calisch TE, Niles DE, Nadkarni VM, Kramer-Johansen J, Olasveengen TM. Ventilation fraction during the first 30s of neonatal resuscitation. Resuscitation. 2016 Oct;107:25-30. doi: 10.1016/j.resuscitation.2016.07.231. Epub 2016 Aug 2.
Results Reference
derived

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

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