← Back to Search

H-HOPE Intervention for Premature Infants

N/A
Recruiting
Led By Rosemary White-Traut, PhD,RN,FAAN
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
male or female
could be receiving oxygen or intravenous therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the completion of the first site's sustaining phase through final analysis of all site data, estimated to be 39 months.
Awards & highlights

Study Summary

This trial is testing whether a standardized early intervention protocol called H-HOPE can be successfully implemented in 5 diverse neonatal intensive care units, and whether it leads to better outcomes for infants and parents, and reduced hospital costs.

Who is the study for?
This trial is for preterm infants born between 23-35 weeks gestational age, now at 31-32 weeks post menstrual age, and their parents. Infants may be on oxygen or IV therapy and previously intubated but must be ready for social interaction. Parents of any background can join; only one infant per multiple births will be analyzed.Check my eligibility
What is being tested?
The H-HOPE Intervention is being tested to see if it can support early brain development in premature infants by providing stimulation (auditory, tactile, visual, vestibular) and helping parents engage with their babies in NICUs and at home.See study design
What are the potential side effects?
Since H-HOPE involves non-invasive stimulation and parental guidance without medical or pharmaceutical intervention, significant side effects are not anticipated. However, the study will monitor all interactions for any unexpected negative responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am either male or female.
Select...
I may be on oxygen or receiving treatment through an IV.
Select...
My health condition is currently stable.
Select...
I am a parent or guardian, regardless of my relationship to the child.
Select...
I was born prematurely, between 23-35 weeks of pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the completion of the first site's sustaining phase through final analysis of all site data, estimated to be 39 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the completion of the first site's sustaining phase through final analysis of all site data, estimated to be 39 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
Aim 1 Outcome Measure: Implementation Success (Change in Reach throughout implementation)
Aim 1 Outcome Measure: Implementation Success (Degree of Implementation)
Aim 1 Outcome Measure: Implementation Success (Percent Change in Sustainability throughout implementation)
+4 more
Secondary outcome measures
Aim 2 Outcome Measure: Cost
Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation)
Other outcome measures
Aim 2 Exploratory Outcome Measure: # Parent NICU visits/days of hospitalization
Aim 2 Exploratory Outcome Measure: Confidence in Care
Anxiety
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: H-HOPE CohortExperimental Treatment1 Intervention
The H-HOPE Cohort will receive the H-HOPE intervention.
Group II: Pre H-HOPE CohortActive Control1 Intervention
The Pre-H-HOPE Comparison Cohort will not receive the H-HOPE intervention, and represents the prior standard (non-HOPE).

Find a Location

Who is running the clinical trial?

Children's Hospital and Health System Foundation, WisconsinOTHER
55 Previous Clinical Trials
92,049 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,655,880 Total Patients Enrolled
Duke UniversityOTHER
2,356 Previous Clinical Trials
3,404,501 Total Patients Enrolled

Media Library

H-HOPE Intervention Clinical Trial Eligibility Overview. Trial Name: NCT04555590 — N/A
Premature Infants Research Study Groups: Pre H-HOPE Cohort, H-HOPE Cohort
Premature Infants Clinical Trial 2023: H-HOPE Intervention Highlights & Side Effects. Trial Name: NCT04555590 — N/A
H-HOPE Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT04555590 — N/A

Frequently Asked Questions

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

Are there numerous medical institutions that have implemented this research effort in Canada?

"There are four primary medical sites that are hosting this trial, such as Advocate Aurora Health in Park Ridge and the University of Chicago. Additionally, there is Children's Hospital of Wisconsin located in Milwaukee and other locations across the country."

Answered by AI

How many participants are being admitted to this trial?

"This research requires 4600 individuals that match the stated selection criteria to partake in this study. Patients can take part at Advocate Aurora Health Park Ridge, Illinois and Children's Hospital of Wisconsin Milwaukee, Wisconsin among other sites."

Answered by AI

Does this research have any vacancies for participants?

"Yes, the details on clinicaltrials.gov indicate that this research endeavor is actively recruiting patients. The initial posting was made November 16th 2020 and an update to the trial occurred March 1st 2022. Currently, there are plans to admit 4,600 participants across four distinct sites."

Answered by AI
~767 spots leftby Dec 2024