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Reducing Visitors- and Personnel-associated Infection Risk on Perinatal Care Station

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ClinicalTrials.gov Identifier: NCT03032887
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg

Brief Summary:

The rate of infectious diseases (amnioninfection syndrome (AIS), fetal inflammatory response syndrome (FIRS), early-onset neonatal sepsis (EONS)) in perinatal care / neonatology is steadily rising in Germany. The hands of the staff and visitors are the most important transmission vehicle of pathogens. Hence hand hygiene is one of the most important measures for the prevention of hospital infections. The different measures of hand hygiene serve to protect against the spread of contamination of the skin with obligate or potentially pathogenic pathogens. Since the use of antibiotics is generally only possible to a limited extent (especially in pregnant women and neonates in perinatal care centers) the primary prophylactic measures are of great importance.

While the importance of hand disinfection in the staff has been undisputed, there is no data on the rate of hand disinfection for visitors of perinatal care centers. Visitor at these stations are common non-compliant persons (especially children!). On the other hand, pregnant women and young mothers and newborn babies are "exposed" to a large number of visitors compared to other stations.

The investigators examine whether special measures (such as voice prompts) have a positive effect on the rate of performed hand disinfections or consecutively on the infection rate.


Condition or disease Intervention/treatment Phase
Hygiene Behavioral: voice prompts Behavioral: agitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Reducing Visitors- and Personnel-associated Infection Risk by Special Agitation Incl. Voice Prompts for Hand Disinfection on Perinatal Care Stations
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: voice prompts
Agitation (education, reminders and optimising materials) plus voice prompts
Behavioral: voice prompts
voice prompts on disinfectant dispenser

Behavioral: agitation
Education, reminders and optimising materials

no voice prompts
only Agitation (education, reminders and optimising materials); no voice prompts
Behavioral: agitation
Education, reminders and optimising materials




Primary Outcome Measures :
  1. Total consumption of disinfectants per visitor [ Time Frame: 9 months ]
    Total consumption of disinfectants per visitor (electronically counted)


Secondary Outcome Measures :
  1. Prevalence of highly positive Impact tests (swab tests) [ Time Frame: 9 months ]
    Prevalence of highly positive Impact tests (swab tests)

  2. Total consumption of disinfectants (only children) per visitor [ Time Frame: 9 months ]
    Total consumption of disinfectants (only children) per visitor

  3. Infection rate of typical maternal, fetal and newborn infections [ Time Frame: 9 months ]
    Infection rate of typical maternal, fetal and newborn infections



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Minimum age: 7 years
  • informed consent
  • Member of target group: Visitor or staff

Exclusion Criteria:

  • Insufficient language skills

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032887


Locations
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Germany
Maternity Clinic/Perinatal Treatment Center, university hospital, Martin-Luther-Universität Halle-Wittenberg
Halle (Saale), Sachsen-Anhalt, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
Publications:
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Responsible Party: Gregor Seliger, Chief resident, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT03032887    
Other Study ID Numbers: Hygienic voice
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Gregor Seliger, Martin-Luther-Universität Halle-Wittenberg:
hygiene
prenatal care
postnatal care
Additional relevant MeSH terms:
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Infection