Health Outcomes of Parents With Cystic Fibrosis

Recruiting

• Conditions: Cystic Fibrosis; Parenthood Status
• Interventions: Other: Parental Status

• Registration Number: NCT05829694
• Lead Sponsor: University of Pittsburgh

Brief Summary

This project will determine the health impact of parenthood on people with cystic fibrosis (CF). The study team will use retrospective data to provide relatively immediate evidence on parenthood's effect on pulmonary health.

Detailed Description

This co-funded study sponsored by the National Institutes of Health and the CF Foundation (CFF) will seek to determine the health impact of parenthood on people with CF in the era of CF transmembrane conductance regulator (CFTR) modulators. To provide relatively immediate evidence on parenthood's effect on pulmonary health and the influence of the introduction and use of all available CFTR modulators, in Aim 1 the study team will assess changes in pre- vs. intra-parenthood percent predicted forced expiratory volume in 1 second (ppFEV1) in a retrospective longitudinal cohort study linking CFF patient registry (CFFPR) data with cross-sectional surveys collected from 249 new parents attending participating United States CF centers between 2012-2022. The study team will identify predictors and timing of lung function loss using 747 non-parents from participating centers as a comparison group and examine the impact of CFTR modulators on parental health.

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-26
• Study Start: 2023-07-12
• Status Verified: 2024-08
• Primary Completion: 2024-08
• Study Completion: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 996

Inclusion Criteria

• Confirmed CF diagnosis with sweat or genotype analysis
• Participant in the CFFPR
• Became a first-time parent between the years 2012-2022 (exposure arm only)

Exclusion Criteria

• Lung transplant prior to becoming a first-time parent (exposure arm) or prior to study period (control)
• Does not speak/read English or Spanish

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parents	Parental Status	Individuals diagnosed with cystic fibrosis who became a first-time parent between January 1, 2012 and December 31, 2022.

Primary Outcome Measures

Name	Time	Method
FEV1	2012-2022	Rate of decline of ppFEV1 as reported in the CFFPR

Secondary Outcome Measures

Name	Time	Method
BMI	2012-2022	BMI as reported in the CFFPR
Rate of pulmonary exacerbations	2012-2022	Rate of pulmonary exacerbations as reported in the CFFPR
Clinic visit attendance	2012-2022	Clinic visit attendance as reported in the CFFPR
Medication Use	2012-2022	Medication use as reported in the CFFPR
CFRD Control	2012-2022	HbgA1c as reported in the CFFPR
Rate of hospitalizations	2012-2022	Rate of hospitalizations as reported in the CFFPR
Microbiologic profile	2012-2022	Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR

Trial Locations

Locations (8)

National Jewish Health; 🇺🇸 Denver, Colorado, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas-Southwestern; 🇺🇸 Dallas, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States