How to support the team, that supports the newborn? Comparison of two teaching methods in the Newborn Life Support and evaluation of critical learning content and the need for telemedical support.
Organizational Data
- DRKS-ID:
- DRKS00029152
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2023-04-25
- Last update in DRKS:
- 2024-01-31
- Registration type:
- Retrospective
Acronym/abbreviation of the study
NeoLITE
URL of the study
No Entry
Brief summary in lay language
Two teaching methods in newborn resuscitation (Newborn Life Support) are to be examined for non-inferiority. Simulation training has proven itself and should ideally be repeated more than once a year, since a loss of knowledge can be demonstrated after just 2 to 6 months. In everyday clinical practice, however, regular participation in training is difficult, and the conditions of the pandemic also make on-site training more difficult. The study aims to investigate whether a web-based refresher course is not significantly inferior to simulation training (H0: µweb-based > µHands on - δ). Study participants are employees of the clinics involved in the initial care of newborns. In addition, the acceptance of web-based offers and simulation training off-side should be compared. As part of the simulation and the theoretical knowledge test, critical points are evaluated, which are particularly important for further Newborn Life Support training courses. In addition, a needs analysis of telemedical support in the care of critically ill newborns is carried out.
Brief summary in scientific language
Two teaching methods in Newborn Life Support (NLS) are to be compared as part of the randomized, controlled, multicentric intervention study. NLS simulation training has proven itself and should ideally be repeated more than once a year, because a loss of knowledge can be detected after just 2 to 6 months. In everyday clinical practice, however, regular participation in training is difficult, and the conditions of the pandemic also make on-site training more difficult. The study aims to investigate whether a web-based refresher course is not significantly inferior to simulation training (H0: µweb-based > µHands on - δ). Study participants are employees of the clinics involved in the initial care of newborns. The initial knowledge transfer of the theory takes place by means of blended learning, which is followed by the NLS simulation training in small groups. 3 months after the initial simulation training, the control group receives the offer of renewed NLS training at the Dorothea-Erxleben-Learning Center Halle (DELH) and the intervention group receives web-based training. Both groups will be re-assessed after 6 months. The theoretical knowledge is determined using the total score from a questionnaire based on Mileder and Gressl and the recommendations of the European Resuscitation Council (ERC). The practical skills are determined within the framework of simulations using the "Performance Checklist to Assess Neonatal Resuscitation Megacode Skill". In addition, the acceptance of web-based offers and simulation training outside the home should be compared. As part of the simulation and the theoretical knowledge test, critical points are evaluated, which are particularly important for further NLS training courses. The Federal Joint Committee specifies the care of premature babies < 1250 g and < 29 weeks' gestation and critically ill newborns in a Level 1 perinatal center, which is intended to ensure improved care for these children. However, risk newborns and premature babies are also born in level 2 and 3 centers, e.g. due to unknown malformations. It can be assumed that there is less experience in the care of these newborns and premature babies. We are therefore planning a needs analysis for telemedical support in the care of critically ill newborns using questionnaires.
Health condition or problem studied
- Free text:
- Newborn Life Support
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- The booster training, after initial in-house training, takes place in the Control group as simulation training in the Dorothea Erxleben learning center in Halle. The theoretical knowledge is determined using the total score from a questionnaire based on Mileder and Gressl and the recommendations of the European Resuscitation Council (ERC). The practical skills are determined within the framework of simulations using the "Performance Checklist to Assess Neonatal Resuscitation Megacode Skill".
- Arm 2:
- The booster training takes place in the intervention group as web-based training. The theoretical knowledge is determined using the total score from a questionnaire based on Mileder and Gressl and the recommendations of the European Resuscitation Council (ERC). The practical skills are determined within the framework of simulations using the "Performance Checklist to Assess Neonatal Resuscitation Megacode Skill".
Endpoints
- Primary outcome:
- It is to be examined whether the knowledge acquired in the context of web-based training is not significantly smaller after an initial simulation training than through further training on the simulation model. The examination takes place three months after the intervention, in order to determine not only short-term effects. The theoretical knowledge is determined using the total score from a questionnaire based on Mileder and Gressl and the recommendations of the European Resuscitation Council (ERC). The practical skills are determined within the framework of simulations using the "Performance Checklist to Assess Neonatal Resuscitation Megacode Skill".
- Secondary outcome:
- Comparison of the acceptance of further training courses that have to be carried out as out-of-house training courses and for which a journey is necessary with web-based, low-threshold further training courses. Identification of critical training content that generates knowledge and is particularly important in the NLS. In addition, the need for telemedical support during initial care of the newborn is determined, as there are no standardized processes or guidelines in this regard.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Pädiatrie I, ANPI Halle Saale
- Medical center Paul-Gerhardt-Stift Wittenberg
- Medical center Carl-von-Basedow-Klinikum Saalekreis gGmbH Merseburg
- Medical center Helios Klinik Sangerhausen Sangerhausen
- Medical center Städtisches Klinikum Dessau Dessau
- Medical center Helios Klinik Köthen Köthen
Recruitment period and number of participants
- Planned study start date:
- 2023-03-06
- Actual study start date:
- 2023-01-10
- Planned study completion date:
- 2024-01-31
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 222
- Final Sample Size:
- 247
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 67 Years
- Additional Inclusion Criteria:
- Registered nurses, midwives, obstetricians, anesthesiologists, pediatricians
Exclusion Criteria
If the employee will leave the company before the last training session.
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum Halle (Saale), AöR Pädiatrie II Abteilung für Neonatologie und pädiatrische Intensivmedizin Ernst-Grube-Str. 40 06120 Halle (Saale)Kathleen PartheyErnst-Grube-Straße 4006120 Halle (Saale)Germany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medizin.uni-halle.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Abteilung für Neonatologie und Pädiatrische Intensivmedizin (ANPI)Department operative und konservative Kinder- und JugendmedizinUniversitätsklinikum Halle (Saale)Kathleen PartheyErnst-Grube-Str. 4006120 HalleGermany
- Telephone:
- 00483455573187
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Abteilung für Neonatologie und Pädiatrische Intensivmedizin (ANPI)Department operative und konservative Kinder- und JugendmedizinUniversitätsklinikum Halle (Saale)Kathleen PartheyErnst-Grube-Str. 4006120 HalleGermany
- Telephone:
- 00493455583187
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Abteilung für Neonatologie und Pädiatrische Intensivmedizin (ANPI)Department operative und konservative Kinder- und JugendmedizinUniversitätsklinikum Halle (Saale)Kathleen PartheyErnst-Grube-Str. 4006120 HalleGermany
- Telephone:
- 00483455573187
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Abteilung für Neonatologie und Pädiatrische Intensivmedizin, Universitätsklinikum HalleErnst-Grube-Strasse 4006120 HalleGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.medizin.uni-halle.de/einrichtungen/kliniken-und-departments/department-fuer-operative-und-konservative-kinder-und-jugendmedizin/abteilung-fuer-neonatologie-und-paediatrische-intensivmedizin
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Medizinischen Fakultät der Martin-Luther-Universität Halle-WittenbergMagdeburger Str. 1206112 Halle (Saale)Germany
- Telephone:
- +49-345-5574476
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2022-06-07
- Ethics committee number:
- 2022-075
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2022-08-22
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- 28.09.2024
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry