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Hypoxia, in Liveborn InfantINSPIRE-DNCT02347241

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

A study testing Educational intervention in people with Hypoxia, in Liveborn Infant and Neonatal Asphyxia, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
435 participants
Where
1 siteNorway
Study dates
Jan 2014to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Parent or health care provider reserved against study participation.

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Oslo University Hospital

    Oslo, Oslo, 0405

Other trials in Norway

About this study

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

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.

Read the 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.

Phase 3 - Intensive run-in of high frequency training and team reflection: "The rolling refresher phase"

  1. 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.
  2. "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.
  3. Continued simulation training will be based on problem areas identified from baseline. Performance during simulation training will be evaluated and registered.
  4. Educational debriefings will continue, as in Phase 2
  5. 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.

Being tested
Educational intervention
Medical subject headings
Asphyxia Neonatorum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational interventionOther

    Educational Debriefings and High frequency training and team reflection

Study groups in NCT02347241
Study groupRoleWhat they receive
Control periodNo interventionAssessment of resuscitation quality and clinical outcomes prior to educational intervention
Educational interventionExperimentalAssessment of resuscitation quality and clinical outcomes after educational intervention consisting of debriefing and rolling refreshers.
Receives: Other: Educational intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Validated performance score assessed by video analysis

    Measured: 12 months

Secondary outcomes (5)
  1. Clinical outcome - Time to effective respiration

    Measured: 12 months

  2. Clinical outcome - Time to heart rate > 100

    Measured: 12 months

  3. Clinical outcome - Admission to intensive care

    Measured: 12 months

  4. Health care providers adherence to guidelines and behaviour markers - Self-reported score

    Measured: 12 months

  5. Health care providers adherence to guidelines and behaviour markers - Simulation score

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionJan 2015
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02347241
Sponsor's protocol ID
2013/12769
Acronym
INSPIRE-D
Status last verified
Sep 2016
First submitted
12 Jan 2015
Last updated
3 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34223356
  • 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.

    PubMed 30009926
  • 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.

    PubMed 27496260

Questions about this trial

What is this clinical trial studying?

A study testing Educational intervention in people with Hypoxia, in Liveborn Infant and Neonatal Asphyxia, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of neonatal resuscitation (Validated performance score assessed by video analysis) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02347241, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2016.

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