Recruiting

Observational StudyHealth Outcomes of Parents With Cystic Fibrosis-Aim 2

Sponsor:

University of Pittsburgh

Code:

NCT06296394

Conditions

Cystic Fibrosis

Parenthood Status

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parenthood

Study Details

Brief summary:

The goal of this observational prospective study is to determine the health impact of parenthood on United States (US) people with CF in the era of CF transmembrane regulator protein (CFTR) modulators. The investigators will collect physical and mental health data to comprehensively evaluate the impact of parenthood in CF with widespread highly effective CFTR modulator use. The main hypotheses this study aims to examine are:

H1: Parents with CF and moderate-to-severe depression have more rapid change in ppFEV1 (percent predicted forced expiratory volume in one second) versus those with mild or no depression.

H2: Parents with CF who have more parental responsibility and/or stress have more rapid ppFEV1 (percent predicted forced expiratory volume in one second) change than those with less responsibility/stress

H3: Parents using CFTR modulators have decreased ppFEV1 (percent predicted forced expiratory volume in one second) change versus those not using CFTR modulators

Participants will complete quarterly surveys during the first year of parenthood and biannual surveys, thereafter, using the computer-based survey system on an iPad protected for infection control or via personal device or computer via emailed survey link.

Conditions

Cystic Fibrosis

Parenthood Status

Study ID

NCT06296394

Start date

May 29, 2024

Status verified date

Nov, 2025

Completion date

Feb 1, 2031

Anticipated

Primary completion date

Feb 1, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Diagnosed with cystic fibrosis via sweat test or genotype analysis
Became a first-time parent (including foster parent, step parent, adoptive parent, or legal guardian) to a child under 5 years of age within the last 180 days

Exclusion Criteria:

Undergone a lung transplant
Does not speak/read English or Spanish

Study Design

Enrollment

146 participants

Anticipated

Interventions and Outcome Measures

Interventions

Parenthood

The intervention group will consist of participants who became first time parents to children under 5 years of age.

Primary outcome measure

Forced Expiratory Volume (FEV1) [ Time Frame: Annually from 2 Years prior to enrollment and annually for Year 1 through Year 5 ]

Central Contacts and Locations

Central contacts

Olivia M Stransky, MPH

412-648-4701 stranskyom@upmc.edu

Locations

University of Alabama-Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

George M Solomon, MD

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Alexandra Wilson

wilsona@njhealth.org

Principal Investigator:

Jennifer Taylor-Cousar, MD, MSCS

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Principal Investigator:

Cynthia Brown, MD

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Megan Behrman

mbehrman@kumc.edu

Principal Investigator:

Amanda Bruce, PhD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Shivani Patel

spate156@jhmi.edu

Principal Investigator:

Natalie West, MD, MPH

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Nivedita Chaudhary

nchaudhary3@mgh.harvard.edu

Principal Investigator:

Anna Georgiopoulos, MD

Boston Children's Hospital/Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jonathan Greenberg

jonathan.greenberg@childrens.harvard.edu

Principal Investigator:

Manuela Cernadas, MD

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Principal Investigator:

Shijing Jia, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Dena Johnson

joh20459@umn.edu

Principal Investigator:

Joanne Billings, MD, MPH

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Principal Investigator:

Daniel Rosenbluth, MD

University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Elisabeth Dellon

elisabeth_dellon@med.unc.edu

Principal Investigator:

Elisabeth Dellon, MD, MPH

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Principal Investigator:

Aaron Trimble, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Denis Hadjiliadis, MD, PhD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Patrick Flume, MD

University of Texas-Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Ashley Keller

ashley.keller@utsouthwestern.edu

Principal Investigator:

Raksha Jain, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Roshni Prabhu

prabhu@medicine.washington.edu

Principal Investigator:

Kathleen Ramos, MD, MS

More Information

Sponsor

University of Pittsburgh

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

cystic fibrosis
parenthood
highly effective modulator therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-11-10.