Clinical trial NCT06915961: Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients
Official title: Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis (CF)
Keywords: Quality Improvement (QI)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-04-08
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will be conducted on 35 children diagnosed with cystic fibrosis, patients will be between the age of 6 years and 18 years old, and they will be selected during their follow-up visits to Pediatric Chest Clinic, Ain Shams University Hospital.

Brief summary: To implement a quality improvement plan aimed at achieving a 5% increase in the Forced expiratory volume in 1st second (FEV1) (% predicted value) in cystic fibrosis (CF) patients with impaired pulmonary function parameters over 12 months. Additionally, the plan aims to measure serum human epididymis protein 4 (HE4) levels in the studied subjects before and after pulmonary function improvement.

Detailed description: This study will be conducted on 35 children diagnosed with cystic fibrosis, aged between 6 and 18 years. Patients will be selected during their follow-up visits to the Pediatric Chest Clinic at Ain Shams University Hospital.

Inclusion Criteria:

A. Pediatric cystic fibrosis 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 cystic fibrosis disease-causing gene mutations.

B. Age ≥6 years. C. Forced expiratory volume in 1st second (FEV₁) ≤80%.

Exclusion Criteria:

A. Patients unable to perform spirometry.

All subjects in the study will undergo an interventional quality improvement plan.

A specialized clinic for CF patients will be established based on the quality improvement (QI) plan, where patients will be followed up every three months by a specialized multidisciplinary team, including a pediatric pulmonologist, pediatric nutrition consultant, pediatric gastroenterologist, chest physiotherapist, and pediatric endocrinologist.

Each specialized clinic will develop and implement standardized cystic fibrosis care algorithms and individualized treatment plans for each patient. These algorithms and plans will be continuously adjusted based on challenges encountered during follow-up to address barriers and deficiencies that may contribute to poor outcomes.

Areas needing improvement will be identified, and appropriate resources and strategies will be proposed. This will include the development of fishbone diagrams, flowcharts, Plan-Do-Study-Act (PDSA) cycles, PDSA ramps, and other quality improvement tools to address specific deficiencies. Additionally, training and engaging the team in quality improvement methodologies will be conducted.

Patients will undergo pulmonary function tests at baseline, followed by assessments at six months and one year during the study.

Eligibility 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.

Primary outcomes:
measure: Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"
timeFrame: 12 months
Secondary outcomes:
measure: Serum HE4 Levels Before and After Pulmonary Function Improvement
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
state: Abbasia
Study officials:
affiliation: Ain Shams University
name: Eman Fawzy
role: PRINCIPAL_INVESTIGATOR
References: