NCT02347241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
435

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 3, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

January 12, 2015

Last Update Submit

September 30, 2016

Conditions

Hypoxia, in Liveborn InfantNeonatal AsphyxiaNeonatal Bradycardia

Outcome Measures

Primary Outcomes (1)

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

    Validated performance score assessed by video analysis

    12 months

Secondary Outcomes (5)

  • 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

  • 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

Study Arms (2)

Control period

NO INTERVENTION

Assessment of resuscitation quality and clinical outcomes prior to educational intervention

Educational intervention

EXPERIMENTAL

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

Other: Educational intervention

Interventions

Educational interventionOTHER

Educational Debriefings and High frequency training and team reflection

Educational intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Parent or health care provider reserved against study participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, Oslo County, 0405, Norway

Location

Related Publications (3)

  • 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.

    PMID: 34223356DERIVED

  • 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.

    PMID: 30009926DERIVED

  • 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.

    PMID: 27496260DERIVED

MeSH Terms

Conditions

Asphyxia Neonatorum

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Theresa M Olasveengen, MD PhD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 27, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

May 1, 2016

Last Updated

October 3, 2016

Record last verified: 2016-09

Locations

NO(1)