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NCT06296394 · ClinicalTrials.gov registry record

Health Outcomes of Parents With Cystic Fibrosis-Aim 2

A clinical trial of Cystic Fibrosis and Parenthood Status, sponsored by University of Pittsburgh.

Recruiting
Registry status
146
Enrollment target
18
Study locations

NCT06296394 is a study of Cystic Fibrosis and Parenthood Status that is actively recruiting participants, run by University of Pittsburgh. The registered enrollment target is 146 participants, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% lower). The trial reports 18 study locations across 16 states.

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The verdict

NCT06296394, a study of Cystic Fibrosis and Parenthood Status, is actively recruiting participants, sponsored by University of Pittsburgh.

RECRUITING
Registry status
146 participants
Enrollment target
18
Study locations

Study 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 Studied

Cystic Fibrosis Parenthood Status

Interventions

  • OTHER Parenthood

Study Locations (18)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Boston Children's Hospital/Brigham and Women's Hospital - Boston

Pennsylvania

  • University of Pennsylvania - Philadelphia
  • University of Pittsburgh - Pittsburgh

Alabama

  • University of Alabama-Birmingham - Birmingham

Colorado

  • National Jewish Health - Denver

Illinois

  • Northwestern University - Evanston

Indiana

  • Indiana University - Indianapolis

Kansas

  • University of Kansas Medical Center - Kansas City

Maryland

  • Johns Hopkins University - Baltimore

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2024-05-29
Est. Completion 2031-02-01

Sponsor

University of Pittsburgh

1,238 total trials

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What the Registry Record Tells You About NCT06296394

The ClinicalTrials.gov registry entry for NCT06296394 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 146 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 178-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (18% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which Parenthood is the first listed.

NCT06296394 reports 18 study locations spanning 16 distinct geographic areas - top geographies include Massachusetts, Pennsylvania, Alabama.

Frequently Asked Questions

What is clinical trial NCT06296394 about?

NCT06296394 is a clinical study titled "Health Outcomes of Parents With Cystic Fibrosis-Aim 2". 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 imp...

What is the current status of trial NCT06296394?

This trial is currently recruiting. The enrollment target is 146 participants. The study started on 2024-05-29. Estimated completion is 2031-02-01.

What conditions does trial NCT06296394 study?

This clinical trial studies the following conditions: Cystic Fibrosis, Parenthood Status.

What interventions are being tested in trial NCT06296394?

The interventions under investigation include: Parenthood (OTHER).

Who is sponsoring clinical trial NCT06296394?

This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06296394 being conducted?

This trial has 18 study locations across Alabama, Colorado, Illinois, Indiana, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.