Improving lung function in children with cystic fibrosis
Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
This study is testing a new plan to help improve lung function in children with cystic fibrosis by seeing if personalized treatment can increase their breathing ability over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Abbasia) |
| Trial ID | NCT06915961 on ClinicalTrials.gov |
What this trial studies
This observational study aims to implement a quality improvement plan to achieve a 5% increase in the Forced Expiratory Volume in 1st second (FEV1) in pediatric patients with cystic fibrosis over a 12-month period. The study will involve 35 children aged 6 to 18 years who have impaired pulmonary function. Participants will be monitored at a specialized clinic where a multidisciplinary team will develop and adjust individualized treatment plans based on standardized care algorithms. Serum levels of human epididymis protein 4 (HE4) will also be measured before and after the intervention to assess its impact on pulmonary function.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients aged 6 to 18 years diagnosed with cystic fibrosis and exhibiting impaired pulmonary function.
Not a fit: Patients who are unable to perform spirometry will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved lung function and overall health in children with cystic fibrosis.
How similar studies have performed: While similar quality improvement initiatives have shown promise in enhancing care for cystic fibrosis, this specific approach is novel in its implementation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric CF patients diagnosed based on the Consensus Guidelines from the Cystic Fibrosis Foundation, with a positive sweat chloride test (≥60 milliequivalent/L) and/or the presence of two CF disease-causing gene mutations. * Age ≥6 years. * Forced expiratory volume in 1 second (FEV₁) ≤80%. Exclusion Criteria: ●Patients are unable to perform spirometry.
Where this trial is running
Cairo, Abbasia
- Ain Shams university — Cairo, Abbasia, Egypt (Recruiting)
Study contacts
- Principal investigator: Eman Fawzy — Ain Shams University
- Study coordinator: Eman Fawzy, MD
- Email: eman199358@gmail.com
- Phone: Egypt: 201011778583
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.