Health Outcomes of Parents With Cystic Fibrosis

Last updated: September 4, 2024
Sponsor: University of Pittsburgh
Overall Status: Completed

Phase

N/A

Condition

Cystic Fibrosis

Lung Disease

Scar Tissue

Treatment

Parental Status

Clinical Study ID

NCT05829694
STUDY22010135
KAZMER22A0
1R01HL161164-01A1
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Lung transplant prior to becoming a first-time parent (exposure arm) or prior tostudy period (control)

  • Does not speak/read English or Spanish

Study Design

Total Participants: 956
Treatment Group(s): 1
Primary Treatment: Parental Status
Phase:
Study Start date:
July 12, 2023
Estimated Completion Date:
August 12, 2024

Study 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.

Connect with a study center

  • National Jewish Health

    Denver, Colorado 80206
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21218
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • University of North Carolina

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • UPMC

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Texas-Southwestern

    Dallas, Texas 75390
    United States

    Site Not Available

  • University of Washington

    Seattle, Washington 98195
    United States

    Site Not Available

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