Actively Recruiting

Age: 6Years +
All Genders
ID06915961

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

Age: 6Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

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

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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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