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Decision Making Guide for Parents of Critically Ill Babies

N/A
Waitlist Available
Led By Monica Lemmon, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
age < 1 year
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, approximately 18 months
Awards & highlights

Study Summary

This trial aims to help parents of critically ill babies make informed decisions using a new tool.

Who is the study for?
This trial is for English-speaking parents of critically ill infants under one year old, admitted to Duke University Hospital. The infant must be facing a serious healthcare decision. All parents meeting these conditions are considered eligible.Check my eligibility
What is being tested?
The study is testing the effectiveness of a decision-making guide designed to help parents navigate and make informed choices regarding the care of their critically ill infants.See study design
What are the potential side effects?
Since this trial involves a decision-making support tool rather than medication, there are no direct medical side effects. However, emotional or psychological impacts may arise from participating in the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, approximately 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study, approximately 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intervention feasibility, as measured by complete data collection rate greater than or equal to 80%
Intervention feasibility, as measured by enrollment rate greater than or equal to 50%
Secondary outcome measures
Parent and clinician acceptability of the intervention as measured by an acceptability questionnaire
Parent preparation for decision making, as measured by the PrepDM
Parent psychological distress, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Use of Decision Making ToolExperimental Treatment1 Intervention
Single Arm design, study team will deliver the tool to be used by the parent(s) to help guide them in discussion with their infant's clinicians.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,484 Total Patients Enrolled
1 Trials studying Critical Illness
300 Patients Enrolled for Critical Illness
Duke UniversityLead Sponsor
2,364 Previous Clinical Trials
3,420,537 Total Patients Enrolled
18 Trials studying Critical Illness
10,699 Patients Enrolled for Critical Illness
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,745 Total Patients Enrolled
9 Trials studying Critical Illness
1,789 Patients Enrolled for Critical Illness

Media Library

Use of Decision Making Tool Clinical Trial Eligibility Overview. Trial Name: NCT05733975 — N/A
Critical Illness Research Study Groups: Use of Decision Making Tool
Critical Illness Clinical Trial 2023: Use of Decision Making Tool Highlights & Side Effects. Trial Name: NCT05733975 — N/A
Use of Decision Making Tool 2023 Treatment Timeline for Medical Study. Trial Name: NCT05733975 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any slots still available for this study at the present time?

"An affirmative, the data available on clinicaltrials.gov affirms that this medical trial is actively recruiting participants. It was first posted on April 26th 2023 and has since been updated as of that same date; there are 75 positions to fill in a single location."

Answered by AI

Are senior citizens eligible to contribute to this clinical research?

"To be considered eligible for this medical trial, applicants must fall within the age bracket of one day up to 1 year old. This particular study is amongst 20 clinical trials targeting patients younger than 18 and 146 studies focused on individuals 65 years or older."

Answered by AI

Is my eligibility sufficient to be included in this research?

"This medical trial seeks 75 patients who suffer from a critical illness and are aged between 1 day to 12 months old. Eligibility for the study depends on whether the participant is an English-speaking parent of an infant admitted in Duke University Hospital, if their child's age is below one year, and if they are expecting any major health care decisions. All applicable parents will be considered as potential candidates."

Answered by AI

What is the enrolment size of this clinical investigation?

"Indeed, clinicaltrials.gov affirms that this medical trial is currently recruiting patients. It was initially posted on April 26th 2023 and the details were last updated around the same time. The research requires 75 volunteers from a single site to participate in the study."

Answered by AI
~55 spots leftby Apr 2025