Barrier protection to lower transmission and infection rates with Gram-negative bacteria in preterm children
Organizational Data
- DRKS-ID:
- DRKS00019103
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-01-16
- Last update in DRKS:
- 2024-01-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Background: Preterm infants requiring intensive care are at high risk to be colonized with pathogens that have a significant potential for invasive infection and nosocomial spread, e.g. multidrug-resistant organisms (MDRO). Along the actual Guidelines of the Commission for Hospital Hygiene and Infection Prevention (KRINKO), barrier protection (Hand Hygiene+gown/gloves) care policy should be used in term and preterm Infants colonized with multidrugresistant gram neg. organisms (MRGN), resistent against 2 classes of antibiotics (2MRGN_NeoPäd). However, there is no empiric evidence if these measures are effective. Aim: To determine the role of barrier precautions for early microbiome imprinting. Hypothesis: We propose that hand hygiene + gown/gloves care policy in 2MRGN_NeoPäd colonized infants in neonatal units as compared to hand hygiene alone has no effect on the rate of garm neg. infections ot on Transmission rate of 2_MRGN pos. pathogens. Design: We will make use of a cluster-randomized controlled trial with cross-over design (2MRGN_Protect) to investigate the hypotheses of non-inferiorty. We will include 12 neonatal Units (mainly in nothern Germany)caring for extrem preterm infants and randomize 6 of the starting with hand hygiene allone, 6 with hand hygiene+ gown/gloves policy. Change of care policy (cross-over) will take place after 12 months. Primary Endpoint is the rate of blood kulture pos. infections with gram neg. bacteria in all term- and preterm infants. Secondary endpoints are i.a. the transmission rate of identic 2_MRGN bacteria. Expected benefit: This study collects prospective data of colonisation with MDRO gram neg. bacteria in preterm infants. It aims to create evidence about the efficiency of the mircrobiotic screening and following additional hygienic measures. In case of non- inferiority, the importance of other point of treatments could be influenced e.g. the improvement of scin-to scin contact of parents and infant. In the long run, the advancement of the Network of nothern german neoantal Units may help to implement overall standart therapeutic principles in antiinfectios therapies.
Brief summary in scientific language
Background: Preterm infants requiring intensive care are at high risk to be colonized with pathogens that have a significant potential for invasive infection and nosocomial spread, e.g. multidrug-resistant organisms (MDRO). This high risk is due to endogen (such as th immaturity of the immune system) and exogen factors (such as Transmission of pathogens on intiensive care Units). Along the actual Guidelines of the Commission for Hospital Hygiene and Infection Prevention (KRINKO), barrier protection (Hand Hygiene+gown/gloves) care policy should be used in term and preterm Infants colonized with multidrugresistant gram neg. organisms (MRGN), resistent against Piperacillin and 3rd Generation Cephaolsprorine (2MRGN_NeoPäd). However, there is no empiric evidence if these measures are effective. Aim: To determine the role of barrier precautions for early microbiome imprinting. Hypothesis: We propose that hand hygiene + gown/gloves care policy in 2MRGN_NeoPäd colonized infants in neonatal units as compared to hand hygiene alone has no effect on the rate of garm neg. infections ot on Transmission rate of 2_MRGN pos. pathogens. Design: We will make use of a cluster-randomized controlled trial with cross-over design (2MRGN_Protect) to investigate the hypotheses of non-inferiorty. We will include 12 neonatal Units (mainly in nothern Germany)caring for extrem preterm infants and randomize 6 of the starting with hand hygiene allone, 6 with hand hygiene+ gown/gloves policy. Change of care policy (cross-over) will take place after 12 months. Primary Endpoint is the rate of blood kulture pos. infections with gram neg. bacteria in all term- and preterm infants. Secondary endpoints are i.a. the transmission rate of identic 2_MRGN bacteria. Expected benefit: This study collects prospective data of colonisation with MDRO gram neg. bacteria in preterm infants. It aims to create evidence about the efficiency of the mircrobiotic screening and following additional hygienic measures. In case of non- inferiority, the importance of other point of treatments could be influenced e.g. the improvement of scin-to scin contact of parents and infant. In the long run, the advancement of the Network of nothern german neoantal Units may help to implement overall standart therapeutic principles in antiinfectios therapies.
Health condition or problem studied
- ICD10:
- P36 - Bacterial sepsis of newborn
- Free text:
- Colonization / Transmission of MDRO (Multi drug resistant organisms)
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Hand Hygiene care policy in 2_MRGN colonized Infants (Term and Preterm) (Intervention): During 12 months, Infants colonized with 2_MRGN pos bacteria are nursed with normal Hand Hygiene care policy without additional barrier protection. All other infants recieve care along lokal hygienic standarts. Hygienic staff training every 6 months and regular Monitoring to ensure good hygienic practise.
- Arm 2:
- Barrier protection (Hand Hygiene+gown/gloves) care policy in 2_MRGN colonized Infants (Term and Preterm, Control): Infants colonized with 2_MRGN pos. bacteria are nursed with barrier protection (gown+gloves) additional to normal Hand Hygiene care policy. All other infants recieve care along lokal hygienic standarts. Hygienic staff training every 6 months and regular Monitoring to ensure good hygienic practise.
Endpoints
- Primary outcome:
- Primary Endpoint is the rate of blood kulture pos. infections with gram neg. bacteria in all term- and preterm infants, in wich a Screening was performed (non- inferiority). This endpoint is defined clinically along NEO-KISS-criteria (two signs of Sepsis + one laboratory sign of Inflammation (e.g. CrP >10mg/dl) and proof of a gram neg. pathogen in bood culture)
- Secondary outcome:
- Secondary endpoints are i.a. the transmission rate of 2_MRGN bacteria. Transmission is postulated if two children are colonized are infected with the same bacteria (with same resistance spectrum) in spaciotemporal connection. Other secondary endpoints are the transmissionrate of other bacteria included in the KRINKO-Screening, rate of all blood-stream infections and clinical infections, number of antibiotic cycles, use of antibiotics of the last resort (e.g. carbapenemes) and consumption rate of antibiotics and desinfectants.
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Crossover
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- Medical center Klinik für Kinder und Jugendmedizin, UKSH, Campus Lübeck Lübeck
- University medical center Klinik für allgemeine Pädiatrie, UKSH, Campus Kiel Kiel
- Medical center Klinikum Itzehoe, Klinik für Kinder- und Jugendmedizin Itzehoe
- Medical center Klinik für Kinder und Jugendmedizin, UKSH, Campus Lübeck Lübeck
- University medical center Klinik für allgemeine Pädiatrie, UKSH, Campus Kiel Kiel
- Medical center Klinikum Itzehoe, Klinik für Kinder- und Jugendmedizin Itzehoe
- Medical center Helios Kliniken Schwerin, Kinder- und Jugedmedizin, Neonatologie Schwerin
- Medical center Asklepios Kliniken Barmbek und Heidberg, Neonatologie Hamburg
- University medical center Universitätsklinikum Tübingen, Klinik für Kinder und Jugendmedizin, Neonatologie Tübingen
- University medical center Universitätsklinikum Essen, Klinik für Kinderheilkunde I, Neonatologie Essen
- University medical center Universitätsklinikum des Saarlandes, Klinik für Allgemeine Pädiatrie und Neonatologie Homburg
- Medical center Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin, Neonatologie Aschaffenburg
- University medical center Universitätsklinikum Tübingen, Klinik für Kinder und Jugendmedizin, Neonatologie Tübingen
- University medical center Universitätsklinikum Essen, Klinik für Kinderheilkunde I, Neonatologie Essen
- Medical center Westküstenklinikum Heide, Klinik für Kinder- und Jugendmedizin Heide
- Medical center Klinikum Aschaffenburg, Klinik für Kinder- und Jugendmedizin, Neonatologie Aschaffenburg
- Medical center Klinikum Memmingen Anstalt des öffentlichen Rechts der Stadt Memmingen Lehrkrankenhaus der Ludwig-Maximilians-Universität München Memmingen
- Medical center Katholisches Kinderkrankenhaus Wilhelmstift Hamburg
Recruitment period and number of participants
- Planned study start date:
- 2020-03-01
- Actual study start date:
- 2020-10-01
- Planned study completion date:
- 2023-12-31
- Actual Study Completion Date:
- 2023-12-31
- Target Sample Size:
- 12
- Final Sample Size:
- 12
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Inclusion of an entire neonatal unit. Analyses of microbiotic Screening-data, not Patient specific data
Exclusion Criteria
Exclusion of a Center in case of missing microbiotic surveillance (KRINKÒ)
Addresses
Primary Sponsor
- Address:
- UNIVERSITÄTSKLINIKUM WÜRZBURG, Kinderklinik und PoliklinikProf. Dr. med. Christoph HärtelJosef-Schneider-Straße 297080 WürzburgGermany
- Telephone:
- +49-931-20127830
- Fax:
- +49-931-20127798
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- UNIVERSITÄTSKLINIKUM WÜRZBURG, Kinderklinik und PoliklinikProf. Dr. med. Christoph HärtelJosef-Schneider-Straße 297080 WürzburgGermany
- Telephone:
- +49-931-201-27830
- Fax:
- +49-931-201-27798
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Universität zu LübeckUniversitätsklinikum Schleswig Holstein, Campus LübeckKlinik für Kinder- und JugendmedizinDr. med. Kirstin FaustRatzeburger Allee 160,23538 LübeckGermany
- Telephone:
- 0451 500-42900
- Fax:
- 0451 500-42904
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- UNIVERSITÄTSKLINIKUM WÜRZBURG, Kinderklinik und PoliklinikProf. Dr. med. Christoph HärtelJosef-Schneider-Straße 297080 WürzburgGermany
- Telephone:
- +49-931-201-27830
- Fax:
- +49-931-201-27798
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Damp Stiftungc/o NGEGSell SpeicherWall 5524103 KielGermany
- Telephone:
- 0431 2203960-00
- Fax:
- 0431 2203960-10
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Med. Fakultät der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-5004639
- Fax:
- +49-451-5003026
- 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:
- 2019-07-18
- Ethics committee number:
- Aktenzeichen 19-275
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-07-22
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:
- Studienprotokoll BALTIC-Studie Stand Dez 2019
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- 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