Evidence map›Paper›PMID 42138920›Full record

Trial reportJAMA network open2026

Extended Barrier Precautions vs Hand Hygiene Alone and Neonatal Sepsis in Intensive Care Patients: The BALTIC Cluster-Randomized Clinical Trial.

Kirstin Faust, Franziska Strecker, Clara Haug, Ursula Felderhoff-Müser, Anja Stein, Reinhard Jensen, Mats Ingmar Fortmann, Janina Marißen, Christine Silwedel, Kirsten Brebach and 22 more

Erratum issuedAbstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in JAMA network open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Error in Visual Abstract.JAMA network open · 2026
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors.

Kirstin FaustDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Franziska StreckerDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Clara HaugDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Ursula Felderhoff-MüserDepartment of Pediatrics I, University of Duisburg-Essen, Essen, Germany.
Anja SteinDepartment of Pediatrics I, University of Duisburg-Essen, Essen, Germany.
Reinhard JensenChildren's Hospital Westküstenklinikum, Heide, Germany.
Mats Ingmar FortmannDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Janina MarißenGerman Center for Infection Research, Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.
Christine SilwedelDepartment of Pediatrics, University Hospital Würzburg, Würzburg, Germany.
Kirsten BrebachChildren's Hospital Memmingen, Memmingen, Germany.
David FrommholdChildren's Hospital Memmingen, Memmingen, Germany.
Christian WiegChildren's Hospital Aschaffenburg-Alzenau, Aschaffenburg, Germany.
Georg HillebrandChildren's Hospital Itzehoe, Itzehoe, Germany.
Barbara NaustChildren's Hospital Itzehoe, Itzehoe, Germany.
Esther SchmidtHelios Children's Hospital Schwerin, Schwerin, Germany.
Lutz KochChildren's Hospital Wilhelmstift Hamburg, Marienhospital Hamburg, Hamburg, Germany.
Susanne SchmidtkeNeonatology, Asklepios Hospital Hamburg-Barmbek, Hamburg, Germany.
Arne SimonDepartment of Pediatric Hematology and Immunology, Saarland University Medical Center, Homburg, Germany.
Michael ZemlinDepartment for General Pediatrics and Neonatology, Saarland University Medical Center, Homburg, Germany.
Sascha MeyerDepartment for General Pediatrics and Neonatology, Saarland University Medical Center, Homburg, Germany.
Christopher ScholzenDepartment for General Pediatrics and Neonatology, Saarland University Medical Center, Homburg, Germany.
Natascha Köstlin-GilleDepartment of Neonatology, University Hospital Tübingen, Tübingen, Germany.
Christian GilleDepartment of Neonatology, University Hospital Heidelberg, Heidelberg, Germany.
Ann-Carolin LongardtDepartment of Pediatrics, University Hospital Schleswig-Holstein, Kiel, Germany.
Wolfgang GöpelDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Manuel KroneInfection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Würzburg, Germany.
Stefanie KampmeierInfection Control and Antimicrobial Stewardship Unit, University Hospital Würzburg, Würzburg, Germany.
Dennis NurjadiGerman Center for Infection Research, Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.
Egbert HertingDepartment of Pediatrics, University Hospital Schleswig-Holstein, Lübeck, Germany.
Jan RuppGerman Center for Infection Research, Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.
Inke R KönigInstitute of Medical Biometry and Statistics, University of Lübeck, Lübeck, Germany.
Christoph HärtelGerman Center for Infection Research, Site Hamburg-Lübeck-Borstel-Riems, Lübeck, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: The effects of contact precautions (ie, gowns and gloves) for individual patients colonized with gram-negative (GN) drug-resistant bacteria on sepsis risk in neonates requiring intensive care remain to be clarified. Objective: To evaluate the noninferiority of standard hand hygiene disinfection vs standard hygiene disinfection plus extended barrier precautions for infants colonized with third-generation cephalosporins-resistant GN bacteria (3GCR-GNB). Design, Setting, and Participants: This cluster-randomized clinical trial was conducted from 2020 to 2023 in 12 German tertiary care neonatal intensive units caring for neonates with high risk for infections with GNB for 24 months, with crossover after 12 months. Follow-up and data curation were completed December 31, 2024, and statistical analysis was finalized on July 31, 2025. Intervention: The intervention was standard hand hygiene disinfection compared with current recommendations, ie, hygiene disinfection plus extended barrier precautions with gowns and gloves for routine care of infants colonized with 3GCR-GNB. Main Outcomes and Measures: The primary outcome was the rate of health care-associated GNB bloodstream infections (BSI) at infant level in all neonates requiring intensive care in the cluster, assuming 5% as noninferiority margin delta; secondary outcomes included transmission rates of 3GCR-GNB and rates of any infection. Results: The primary analysis was based on an overall sample size of 12 sites with crossover at 12 months, making 24 clusters with 9731 neonates. During the standard hand hygiene disinfection periods, 22 of 4699 infants (0.5%) developed GNB BSIs at infant level, compared with 25 of 5032 infants (0.5%) cared for during the extended barrier precaution periods (risk difference [RD], -0.03%; 95% CI, -0.43% to 0.38%; noninferiority P < .001). At least 1 nosocomial transmission with 3GCR-GNB was noted during 41 of 144 months in the intervention period and 54 of 144 months in the control period (RD, -9.03%; 95% CI, -27.79% to 9.74%), with involvement of 116 patients (2.5%) vs 149 patients (3.0%) (RD, -0.44%, 95% CI, -2.47% to 1.58%). The total rate of BSI was 2.1% in neonates during the intervention period vs 2.0% during the control period (RD, 0.12%; 95% CI, -1.39% to 1.64%). Conclusions and Relevance: In this cluster-randomized clinical trial, standard hand hygiene disinfection for the care of infants colonized with 3GC-GNB was noninferior to standard hygiene disinfection plus extended barrier precautions. Trial Registration: German Clinical Trials Register identifier: DRKS00019103.

Indexed as

Cross InfectionHand HygieneInfection ControlNeonatal SepsisFemaleGermanyHumansInfant, NewbornIntensive Care Units, NeonatalMaleProtective ClothingSepsis

Identifiers

PMID42138920
PMCPMC13179548

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.