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 Parthey
Ernst-Grube-Straße 40
06120 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 Parthey
Ernst-Grube-Str. 40
06120 Halle
Germany
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 Parthey
Ernst-Grube-Str. 40
06120 Halle
Germany
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 Parthey
Ernst-Grube-Str. 40
06120 Halle
Germany
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 Halle
Ernst-Grube-Strasse 40
06120 Halle
Germany
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-Wittenberg
Magdeburger Str. 12
06112 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
UTN (Universal Trial Number):
No Entry
EUDAMED 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