Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
NCT ID: NCT05744609
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6000 participants
OBSERVATIONAL
2017-01-01
2022-12-31
Brief Summary
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1. Develop a risk prediction model based on demographic, comorbidity, clinical characteristics, laboratory data, and chest radiographic reports to predict severe outcomes among children hospitalized with CAP;
2. Develop a risk scoring system and determine the cut-off point;
3. Externally validate the easy-to-use risk score.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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children hospitalized with community-acquired pneumonia
exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
epidemiological data (e.g., age, sex, and residential area), clinical characteristics (e.g., fever, cough, and wheeze), laboratory data (e.g., white blood cell, c-reaction protein, and procalcitonin), and chest radiographic reports (e.g., X-ray, CT, and ultrasound)
Interventions
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exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
epidemiological data (e.g., age, sex, and residential area), clinical characteristics (e.g., fever, cough, and wheeze), laboratory data (e.g., white blood cell, c-reaction protein, and procalcitonin), and chest radiographic reports (e.g., X-ray, CT, and ultrasound)
Eligibility Criteria
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Inclusion Criteria
2. Admitted to hospital with signs or symptoms of acute infection (eg, fever) and acute respiratory illness (eg, cough), and radiographic evidence of pneumonia.
Exclusion Criteria
2. Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.
29 Days
18 Years
ALL
No
Sponsors
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Children's Hospital of Fudan University
OTHER
Responsible Party
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Locations
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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References
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Riley RD, Ensor J, Snell KIE, Harrell FE Jr, Martin GP, Reitsma JB, Moons KGM, Collins G, van Smeden M. Calculating the sample size required for developing a clinical prediction model. BMJ. 2020 Mar 18;368:m441. doi: 10.1136/bmj.m441. No abstract available.
Tseng CC, Tu CY, Chen CH, Wang YT, Chen WC, Fu PK, Chen CM, Lai CC, Kuo LK, Ku SC, Fang WF. Significance of the Modified NUTRIC Score for Predicting Clinical Outcomes in Patients with Severe Community-Acquired Pneumonia. Nutrients. 2021 Dec 31;14(1):198. doi: 10.3390/nu14010198.
Florin TA, Ambroggio L, Brokamp C, Zhang Y, Rattan M, Crotty E, Belsky MA, Krueger S, Epperson TN 4th, Kachelmeyer A, Ruddy R, Shah SS. Biomarkers and Disease Severity in Children With Community-Acquired Pneumonia. Pediatrics. 2020 Jun;145(6):e20193728. doi: 10.1542/peds.2019-3728. Epub 2020 May 13.
Jain S, Williams DJ, Arnold SR, Ampofo K, Bramley AM, Reed C, Stockmann C, Anderson EJ, Grijalva CG, Self WH, Zhu Y, Patel A, Hymas W, Chappell JD, Kaufman RA, Kan JH, Dansie D, Lenny N, Hillyard DR, Haynes LM, Levine M, Lindstrom S, Winchell JM, Katz JM, Erdman D, Schneider E, Hicks LA, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Finelli L; CDC EPIC Study Team. Community-acquired pneumonia requiring hospitalization among U.S. children. N Engl J Med. 2015 Feb 26;372(9):835-45. doi: 10.1056/NEJMoa1405870.
Florin TA, Ambroggio L, Lorenz D, Kachelmeyer A, Ruddy RM, Kuppermann N, Shah SS. Development and Internal Validation of a Prediction Model to Risk Stratify Children With Suspected Community-Acquired Pneumonia. Clin Infect Dis. 2021 Nov 2;73(9):e2713-e2721. doi: 10.1093/cid/ciaa1690.
Other Identifiers
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20230203
Identifier Type: -
Identifier Source: org_study_id
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