Actively Recruiting
Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Quality Improvement Protocol in Children with Cystic Fibrosis
Led by Ain Shams University · Updated on 2025-04-08
35
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a quality improvement plan to increase lung function, measured by forced expiratory volume in 1 second (FEV1), in children with cystic fibrosis who have impaired lung function. The study also aims to measure levels of serum human epididymis protein 4 (HE4) before and after improvements in lung function. This observational study involves 35 children aged 6 to 18 years who have been diagnosed with cystic fibrosis with specific lung function criteria. All participants will be followed in a specialized cystic fibrosis clinic established under the quality improvement plan. This clinic is managed by a multidisciplinary team including pediatric lung, nutrition, gastroenterology, chest physiotherapy, and endocrinology specialists. The team will create and adjust individualized treatment plans and care algorithms every three months, using quality improvement tools such as fishbone diagrams and Plan-Do-Study-Act cycles to address areas needing improvement. Participants will have pulmonary function tests at the beginning of the study, then at six months, and finally at one year. The study will monitor changes in lung function and serum HE4 levels over 12 months. The specialized team will track progress and make ongoing adjustments to care to better support each child’s health. The total participation time is one year with regular follow-up visits.
CONDITIONS
Brief Title
Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric cystic fibrosis patients diagnosed based on Consensus Guidelines with a positive sweat chloride test (≥60 milliequivalent/L) and/or two disease-causing gene mutations
- Age 6 years or older
- Forced expiratory volume in 1 second (FEV1) of 80% predicted value or less
You will not qualify if you...
- Patients unable to perform spirometry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants who undergo routine care are observed while a quality improvement protocol is implemented to enhance cystic fibrosis care and pulmonary function.
Follow-up visits every 3 months at a specialized cystic fibrosis clinic
Trial Site Locations
Total: 1 location
1
Ain Shams university
Cairo, Abbasia, Egypt, 00202
Actively Recruiting
Research Team
E
Eman Fawzy, MD
T
Terez Boshra
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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