Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

Pneumonia Clinical Trial

Official title:

Development and Validation of a Risk Score for Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05744609
• Other study ID #: 20230203
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, investigators aimed to develop and validate a risk score to predict severe outcomes (e.g., mortality and ICU admission) in children who were admitted to the Children's Hospital of Fudan University between 2017 and 2022 due to community-acquired pneumonia (CAP). The objectives were as follows. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6000
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 29 Days to 18 Years

Eligibility

Inclusion Criteria:

1. Aged between 29 days and 18 years old;

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:

1. Pneumonia developed 48 hours after admission or intubation;

2. Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.

Related Conditions & MeSH terms

• Child
• Pneumonia
• Prognosis

Intervention

Other:
• 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)

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. Erratum In: Pediatrics. 2020 Sep;146(3): — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality	in-hospital mortality among children hospitalized with CAP	from admission to discharge, an average of 7 days
Secondary	admission to ICU	admission to a intensive care unit for over 24 hours	from admission to discharge, an average of 7 days
Secondary	septic shock	occurrence of septic shock during admission	from admission to discharge, an average of 7 days
Secondary	treatment for severe pneumonia	vasoactive agents, positive-pressure ventilation or chest drainage, or extracorporeal membrane oxygenation	from admission to discharge, an average of 7 days