Cystic Fibrosis, Parenthood Status
Conditions
Keywords
cystic fibrosis, parenthood, highly-effective modulator therapy
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.
Interventions
OTHERParental Status
The aim of the study is to assess the impact parenthood has on health outcomes.
Sponsors
Cystic Fibrosis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
University of Pittsburgh
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 | 2012-2022 | Rate of decline of ppFEV1 as reported in the CFFPR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of hospitalizations | 2012-2022 | Rate of hospitalizations as reported in the CFFPR |
| Clinic visit attendance | 2012-2022 | Clinic visit attendance as reported in the CFFPR |
| BMI | 2012-2022 | BMI as reported in the CFFPR |
| Rate of pulmonary exacerbations | 2012-2022 | Rate of pulmonary exacerbations as reported in the CFFPR |
| CFRD Control | 2012-2022 | HbgA1c as reported in the CFFPR |
| Microbiologic profile | 2012-2022 | Presence of specific types of bacteria, mycobacteria, fungus in cultures as reported in the CFFPR |
| Medication Use | 2012-2022 | Medication use as reported in the CFFPR |
Countries
United States
Outcome results
None listed