PneumoniaNCT05744609
Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
An observational study of Pneumonia and Child, run by Children's Hospital of Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- What is being tested?
- exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
- How many people
- 6,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Aged between 29 days and 18 years old;
- Admitted to hospital with signs or symptoms of acute infection (eg, fever) and acute respiratory illness (eg, cough), and radiographic evidence of pneumonia.
Who cannot join
- Pneumonia developed 48 hours after admission or intubation;
- Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Development and Validation of a Risk Score for Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
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.
- 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;
- Develop a risk scoring system and determine the cut-off point;
- Externally validate the easy-to-use risk score.
- Being tested
- exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reportsOther
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)
| Study group | Role | What they receive |
|---|---|---|
| children hospitalized with community-acquired pneumonia | Not described Receives: Other: exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
in-hospital mortality among children hospitalized with CAP
Measured: from admission to discharge, an average of 7 days
Secondary outcomes (3)
admission to ICU
admission to a intensive care unit for over 24 hours
Measured: from admission to discharge, an average of 7 days
septic shock
occurrence of septic shock during admission
Measured: from admission to discharge, an average of 7 days
treatment for severe pneumonia
vasoactive agents, positive-pressure ventilation or chest drainage, or extracorporeal membrane oxygenation
Measured: from admission to discharge, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744609
- Sponsor's protocol ID
- 20230203
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 32188600Tseng 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 35011073Florin 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.
PubMed 32404432Jain 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 25714161Florin 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Risk Score for Predicting Severe Outcomes Among Children Hospitalized With Community-acquired Pneumonia
- ClinicalTrials.gov ID
- NCT05744609
- Acronym / sponsor ID
- 20230203
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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;
- Develop a risk scoring system and determine the cut-off point;
- Externally validate the easy-to-use risk score.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children hospitalized with community-acquired pneumonia | – | Other: exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reports |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Aged between 29 days and 18 years old;
- Admitted to hospital with signs or symptoms of acute infection (eg, fever) and acute respiratory illness (eg, cough), and radiographic evidence of pneumonia.
Key exclusion criteria (2 listed)
- Pneumonia developed 48 hours after admission or intubation;
- Chronic pneumonia, tuberculosis, tracheobronchial foreign bodies, aspiration pneumonia, parasitic lung disease, and diffuse pulmonary interstitial/parenchyma disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exposures of interest: epidemiological data, clinical characteristics, laboratory data, and chest radiographic reportsepidemiological 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) | Other | children hospitalized with community-acquired pneumonia |
Primary outcome
in-hospital mortality
Time frame: from admission to discharge, an average of 7 days
in-hospital mortality among children hospitalized with CAP
3 secondary outcomes
admission to ICU
Time frame: from admission to discharge, an average of 7 days
septic shock
Time frame: from admission to discharge, an average of 7 days
treatment for severe pneumonia
Time frame: from admission to discharge, an average of 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Background: PubMed 32188600Riley 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.
- Background: PubMed 35011073Tseng 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.
- Background: PubMed 32404432Florin 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.
- Background: PubMed 25714161Jain 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.
- Background: PubMed 33159514Florin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Child, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: from admission to discharge, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05744609, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.