{
  "abstract": "Introduction Preterm infants, particularly those born before 29 weeks of gestation, are at increased risk of developing bronchopulmonary dysplasia (BPD) and other complications of prematurity. Substantial evidence suggests that respiratory tract colonisation with Ureaplasma species significantly contributes to pulmonary inflammation, impaired lung function and subsequent lung disease especially in very immature infants. Moreover, Ureaplasma exposure has been implicated in the pathogenesis of other inflammation-related sequelae of prematurity. Although representing a potentially actionable risk factor for adverse short-term and long-term neonatal outcome, controversies on Ureaplasma-associated morbidity remain and recommendations for screening practices in preterm infants are missing. The NEO-CONSCIOUS (Neonatal Colonisation and Infection with Ureaplasma in very immature preterm infants born <29 weeks of gestation) study aims to assess the incidence of Ureaplasma colonisation and infection in very preterm infants at high risk of adverse outcome, the extent of potentially accompanying inflammation and the impact on short-term and long-term morbidity.Methods and analysis This is a prospective observational multicentre study being conducted in level III neonatal intensive care units in Germany and Austria. In total, 400 infants born before 29 weeks of gestation are screened for Ureaplasma colonisation immediately after birth. In addition, biomarkers of systemic inflammation are determined on day 1 and day 28. The study infants are followed up until discharge and at 2 years corrected age. The primary outcome BPD and/or death is assessed at 36 weeks postmenstrual age. Secondary outcomes include systemic inflammation, secondary infections, intraventricular haemorrhage, periventricular leukomalacia, necrotising enterocolitis, retinopathy of prematurity and neurodevelopmental outcome at 24 months corrected age.Ethics and dissemination The study has been approved by the ethics committees in Würzburg and Leipzig and the local ethics committees of all participating centres. Results will be disseminated through peer-reviewed international publications and conferences. The study is registered with the German Clinical Trials Register, ID DRKS00033001.Trial registration number German Clinical Trials Register (DRKS00033001).",
  "authors": [
    {
      "affiliations": [
        "Division of Neonatology, Department of Women’s and Children’s Health, University of Leipzig Medical Center, Leipzig, Germany"
      ],
      "name": "Kirsten Glaser"
    },
    {
      "affiliations": [
        "Division of Neonatology, Pediatric Intensive Care and Neuropediatrics, Department of Pediatrics and Adolescent Medicine, Comprehensive Centre for Pediatrics, Medical University of Vienna, Vienna, Austria",
        "Department of Neonatology, Women's and Children's Clinic, Kepler University Hospital, Linz, Austria"
      ],
      "name": "Judith Rittenschober-Böhm"
    },
    {
      "affiliations": [
        "Department of Pediatrics, University Hospital Münster, Münster, Germany"
      ],
      "name": "Alexander Humberg"
    },
    {
      "affiliations": [
        "Department of Pediatrics, University Hospital of Lübeck, Lübeck, Germany"
      ],
      "name": "Guido Stichtenoth"
    },
    {
      "affiliations": [
        "University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Pediatrics, Division of Pediatric Infectious Diseases, Köln, Germany"
      ],
      "name": "Sarina Butzer"
    },
    {
      "affiliations": [
        "University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Pediatrics, Division of Pediatric Infectious Diseases, Köln, Germany",
        "University of Cologne, Faculty of Medicine and University Hospital Cologne, Department of Pediatrics, Division of Neonatology, Köln, Germany"
      ],
      "name": "Katrin Mehler"
    },
    {
      "affiliations": [
        "Department of Neonatology and Pediatric Intensive Care Medicine, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany"
      ],
      "name": "Florian Kipfmüller"
    },
    {
      "affiliations": [
        "Department of Neonatology, Tübingen University Children’s Hospital, Tübingen, Germany",
        "Department of Neonatology, Heidelberg University, Medical Faculty, Heidelberg, Germany"
      ],
      "name": "Natascha Köstlin-Gille"
    },
    {
      "affiliations": [
        "Department of Neonatology, Heidelberg University, Medical Faculty, Heidelberg, Germany"
      ],
      "name": "Christian Gille"
    },
    {
      "affiliations": [
        "Klinik Hallerwiese-Cnopf’sche Kinderklinik, Clinic for Neonatology and Paediatric Intensive Care, Nürnberg, Germany"
      ],
      "name": "Andrea Kick"
    },
    {
      "affiliations": [
        "Division of Neonatology, Department of Women’s and Children’s Health, University of Leipzig Medical Center, Leipzig, Germany"
      ],
      "name": "Diana Dornis"
    },
    {
      "affiliations": [
        "Institute of Medical Microbiology and Hospital Hygiene, University Clinic of Heinrich-Heine University Düsseldorf, Düsseldorf, Germany"
      ],
      "name": "Birgit Henrich"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-Maternal Medicine, Medical University of Vienna, and Comprehensive Center for Pediatrics (CCP), Medical University of Vienna, Vienna, Austria"
      ],
      "name": "Alex Farr"
    },
    {
      "affiliations": [
        "University Hospital Würzburg, University of Würzburg, Department of Pediatrics, Würzburg, Germany"
      ],
      "name": "Christoph Härtel"
    },
    {
      "affiliations": [
        "University Hospital Würzburg, University of Würzburg, Department of Pediatrics, Würzburg, Germany"
      ],
      "name": "Christine Silwedel"
    }
  ],
  "title": "Study protocol: neonatal colonisation and infection with Ureaplasma in very immature preterm infants born <29 weeks of gestation (NEO-CONSCIOUS) – a prospective multicentre study assessing early life colonisation rates and potentially associated adverse outcomes",
  "uid": "8adcee73-4193-55a8-aed1-d8ddcb3ef8db"
}