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CompletedNCT05744609Updated Feb 27, 2023

Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia

An observational study in Pneumonia, Child and Prognosis, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 29 Days to 18 Years. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Children's Hospital of Fudan University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
6,000
Ages
29 Days to 18 Years
Sex
All
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Study 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.
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Conditions studied

  • Pneumonia
  • Child
  • Prognosis

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03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 6,000 is above the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Children's Hospital of Fudan University is the lead sponsor of 262 studies on the registry; 92 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
29 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This was a retrospective cohort study of children aged between > 29 days and 18 years old who were admitted to the Children's Hospital of Fudan University in Shanghai, China from January 1, 2017 to December 31, 2022. Children were enrolled if they were hospitalized with signs and symptoms of lower respiratory tract infection and radiographic evidence of pneumonia.

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

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.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
6,000 participants (actual)
Patient registry
No

Groups and cohorts

  • children hospitalized with community-acquired pneumonia

    Other: exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports

Interventions

  • Otherexposures 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)

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What researchers measure

Primary outcomes

  1. in-hospital mortality

    in-hospital mortality among children hospitalized with CAP

    Time frame: from admission to discharge, an average of 7 days

Secondary outcomes

  1. admission to ICU

    admission to a intensive care unit for over 24 hours

    Time frame: from admission to discharge, an average of 7 days

  2. septic shock

    occurrence of septic shock during admission

    Time frame: from admission to discharge, an average of 7 days

  3. treatment for severe pneumonia

    vasoactive agents, positive-pressure ventilation or chest drainage, or extracorporeal membrane oxygenation

    Time frame: from admission to discharge, an average of 7 days

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Study locations

1 site
  • Children's Hospital of Fudan University
    Shanghai, Shanghai 201102, China
08

References and documents

Publications

  • 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. PubMed 32188600 ↗
  • 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. PubMed 35011073 ↗
  • 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):e2020011452. doi: 10.1542/peds.2020-011452. PubMed 32404432 ↗
  • 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. PubMed 25714161 ↗
  • 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. PubMed 33159514 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05744609
Lead sponsor
Children's Hospital of Fudan University
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Jan 1, 2017
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022
Last update
Feb 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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