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NCT Number: NCT06915961

Epididymis Protein 4 and Pulmonary Function With Quality Improvement Protocol Among Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis (CF) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams university

Cairo, Abbasia, 00202, Egypt

Location status: Recruiting

Location contact

Ain Shams university Ain Shams university, MD

CONTACT

[email protected]

01011778583

Eman Fawzy, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Quality Improvement Protocol for Achieving a 5% Increase in FEV₁% Predicted Value in CF Patients"

    Time frame: 12 months

    Implementation of a quality improvement protocol to achieve a 5% increase in the FEV₁% predicted value in cystic fibrosis patients with impaired pulmonary function. Pulmonary function will be assessed using spirometry at baseline, six months, and 12 months.

Secondary outcomes

  1. Serum HE4 Levels Before and After Pulmonary Function Improvement

    Time frame: 12 months

    Measurement of HE4 levels in the serum of studied subjects before and after pulmonary function improvement. HE4 levels will be assessed using a standardized laboratory assay at baseline and after 12 months.

Study contacts

Contact information is provided by the study sponsor or research team.

Eman Fawzy, MD

CONTACT

[email protected]

Egypt: 201011778583

Terez Boshra

CONTACT

[email protected]

+201224035744

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Serum Human Epididymis Protein 4 and Pulmonary Function Before and After Structural Quality Improvement Protocol Among Cystic Fibrosis Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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