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| Name | Class |
|---|---|
| St George's, University of London | OTHER |
| PENTA Foundation | NETWORK |
| Universiteit Antwerpen | OTHER |
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Prospective, multinational, multicentre, observational cohort study of neonatal sepsis in partner institutions. The cohort study will be designed to evaluate health care utilization and current clinical practice and to assess risk factors for and outcomes of babies with neonatal sepsis (culture-negative and culture-positive).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Study Clinical Sepsis | Clinical and Antimicrobial Assessments |
| |
| Microbiology Sub study | Clinical and Antimicrobial Assessments |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Main study clinical sepsis | Other | No intervention-Observational study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate | To estimate mortality rates in hospitalised infants less than 60 days of age who are being treated for significant sepsis (where significant is defined as presenting with 2 or more of the signs /symptoms listed in the inclusion criteria). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the microbiological epidemiology, including antimicrobial susceptibility and resistance mechanisms, in infants with positive blood and/or cerebrospinal fluid culture | The incidence of culture positive and culture negative sepsis (both bloodstream and CSF isolates) | 28 days |
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Inclusion Criteria:
In-patient in the hospital (NNU (Neonatal unit) or paediatric ward) of one of the partner institutions
Exclusion Criteria:
• Previously enrolled in this study, unless readmitted and re-started on antibiotics before the 28 day follow-up limit is reached
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Hospitalized Babies with significant sepsis
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| Name | Affiliation | Role |
|---|---|---|
| Mike Sharland | St George's, University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Shishu Hospital | Dhaka | Bangladesh | ||||
| FCM da Santa Casa de São Paulo |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29025624 | Background | Folgori L, Ellis SJ, Bielicki JA, Heath PT, Sharland M, Balasegaram M. Tackling antimicrobial resistance in neonatal sepsis. Lancet Glob Health. 2017 Nov;5(11):e1066-e1068. doi: 10.1016/S2214-109X(17)30362-5. No abstract available. | |
| 37289666 | Derived | Russell NJ, Stohr W, Plakkal N, Cook A, Berkley JA, Adhisivam B, Agarwal R, Ahmed NU, Balasegaram M, Ballot D, Bekker A, Berezin EN, Bilardi D, Boonkasidecha S, Carvalheiro CG, Chami N, Chaurasia S, Chiurchiu S, Colas VRF, Cousens S, Cressey TR, de Assis ACD, Dien TM, Ding Y, Dung NT, Dong H, Dramowski A, Ds M, Dudeja A, Feng J, Glupczynski Y, Goel S, Goossens H, Hao DTH, Khan MI, Huertas TM, Islam MS, Jarovsky D, Khavessian N, Khorana M, Kontou A, Kostyanev T, Laoyookhon P, Lochindarat S, Larsson M, Luca M, Malhotra-Kumar S, Mondal N, Mundhra N, Musoke P, Mussi-Pinhata MM, Nanavati R, Nakwa F, Nangia S, Nankunda J, Nardone A, Nyaoke B, Obiero CW, Owor M, Ping W, Preedisripipat K, Qazi S, Qi L, Ramdin T, Riddell A, Romani L, Roysuwan P, Saggers R, Roilides E, Saha SK, Sarafidis K, Tusubira V, Thomas R, Velaphi S, Vilken T, Wang X, Wang Y, Yang Y, Zunjie L, Ellis S, Bielicki JA, Walker AS, Heath PT, Sharland M. Patterns of antibiotic use, pathogens, and prediction of mortality in hospitalized neonates and young infants with sepsis: A global neonatal sepsis observational cohort study (NeoOBS). PLoS Med. 2023 Jun 8;20(6):e1004179. doi: 10.1371/journal.pmed.1004179. eCollection 2023 Jun. |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Microbiological isolates
| Microbiology sub study | Other | Analysis of Bacterial isolates |
|
| São Paulo |
| Brazil |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto | São Paulo | Brazil |
| Beijing Children Hospital | Beijing | China |
| Beijing Obstetrics and Gynecology Hospital | Beijing | China |
| Shenzhen Children Hospital | Shenzhen | China |
| Hippokration Hospital | Thessaloniki | Greece |
| King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College | Mumbai | India |
| Lady Hardinge Medical College | New Delhi | India |
| Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) | Puducherry | India |
| Bambino Gesu Hospital | Rome | Italy |
| KEMRI/Wellcome Trust Research Programme | Kilifi | Kenya |
| Tygerberg Hospital | Cape Town | South Africa |
| Charlotte Maxeke | Johannesburg | South Africa |
| Chris Hani Baragwanath Academic Hospital | Johannesburg | South Africa |
| Queen Sirikit National Institute of Child Health | Bangkok | Thailand |
| Chiang Rai Prachanukroh Hospital | Chiang Rai | Thailand |
| Mulago Hospital | Kampala | Uganda |
| Vietnam National Hospital of Paediatrics | Hanoi | Vietnam |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |