NCT05768204

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Baoping XU · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Severe Pneumonia

Interventions

Type	Name	Description
DRUG	Prednisolone Acetate	The experimental group took prednisolone acetate which is a kind of oral glucocorticoid.
OTHER	placebo	A placebo consistent in appearance with the prednisolone acetate.

Timeline

• Start date: 2023-03-10
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-03-14
• Last updated: 2023-03-14

Locations

3 sites across 1 country: China