Research on the Treatment of Severe Community-acquired Pneumonia in Children

  • STATUS
    Recruiting
  • End date
    Dec 1, 2025
  • participants needed
    160
  • sponsor
    Baoping XU
Updated on 6 April 2023

Summary

The need for glucocorticoid therapy in children with severe community-acquired pneumonia in the acute phase of the disease remains unclear. The implementation of this study could provide strong evidence on the need for adjuvant glucose therapy in children with severe community-acquired pneumonia.

Description

The use of glucocorticoid for severe community-acquired pneumonia in children is still controversial in clinic. There is still a lack of high quality clinical research results in this field. That's the purpose of this study. The study used oral glucocorticoids and placebos. It was a multicenter clinical study involving 160 people. The enrolled subjects were treated for 5 days after basic assessment, and the use of experimental drugs and changes in clinical manifestations and laboratory examination were strictly recorded. The possible adverse hormonal reactions such as hyperglycemia, hypertension and gastrointestinal ulcer bleeding should be closely monitored and appropriate treatment measures should be taken in time. Subject will be allowed to terminate the test if necessary. Record and discuss similar events. The double blind principle is strictly observed during the experiment to ensure the authenticity and reliability of the experimental data.

Details
Condition Severe Pneumonia
Treatment Placebo, Prednisolone acetate
Clinical Study IdentifierNCT05768204
SponsorBaoping XU
Last Modified on6 April 2023

Eligibility

Yes No Not Sure

Inclusion Criteria

1 month-< 18 years old
Clinical diagnosis of community-acquired pneumonia (fever, cough, sputum, chest pain, dyspnea, abnormal breath sounds in the lungs, imaging pneumonia changes)
Meet any of the following
(1) the general condition is very poor
(2) refusal to eat or dehydration
(3) Significantly increased respiratory rate (70 times/min > infants, 50 times/min for older children>)
(4) dyspnea (three concave sign, moaning, nasal flapping)
(5) hypoxemia (cyanosis, transcutaneous oxygen saturation< 92% (not oxygenated))
(6) Pulmonary infiltration≥ 2/3 lung or multilobar infiltration
(7) There is a pleural effusion
(8) Extrapulmonary complications

Exclusion Criteria

Systemic corticosteroids have been used to treat pneumonia before admission
Use systemic glucocorticoids within 3 months before admission
Hospital-acquired pneumonia
Children with history of tuberculosis, branch expansion, tumors, immune deficiency, congenital heart, chronic pulmonary heart disease, kidney disease, severe malnutrition, recurrent respiratory infections, congenital bronchopulmonary dysplasia (BPD) and other underlying diseases
Unconscious, need endotracheal intubation, children admitted to ICU
Those who are allergic to the drugs or their preparation components involved in the study
Those with hormonal contraindications: hypertension, diabetes, active peptic ulcer, adrenal hyperfunction, corneal ulcer, increased intraocular pressure, severe psychosis
There is a current infection that is difficult to control with antibacterial drugs
Children who are participating in other clinical trials
The investigator believes that it is not suitable to participate in the study
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