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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
born between 23-35 weeks gestational age (GA)
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
No Placebo-Only Group

Summary

This trial tests the H-HOPE program, which helps preterm infants develop through sensory stimulation and supports parents in interacting with their babies. The study aims to see if H-HOPE can be successfully used in different NICUs and if it improves infant health and reduces costs. The results could lead to widespread use of H-HOPE in hospitals. H-HOPE is a standardized behavioral intervention with an infant-directed component designed to optimize developmental trajectories and increase parents' interactive engagement with their infants.

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Aim 2 Outcome Measure: Cost
Aim 3 Outcome Measure: CFIR influences (Number of facilitators and barriers to implementation)
Other study objectives
Aim 2 Exploratory Outcome Measure: # Parent NICU visits/days of hospitalization
Aim 2 Exploratory Outcome Measure: Confidence in Care
Anxiety
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,065 Previous Clinical Trials
2,742,343 Total Patients Enrolled
Duke UniversityOTHER
2,461 Previous Clinical Trials
2,964,224 Total Patients Enrolled
University of ChicagoOTHER
1,059 Previous Clinical Trials
835,153 Total Patients Enrolled
Advocate Health CareOTHER
56 Previous Clinical Trials
1,410,119 Total Patients Enrolled
Wake Forest University Health SciencesOTHER
1,399 Previous Clinical Trials
2,455,599 Total Patients Enrolled
Advocate Aurora HealthUNKNOWN
2 Previous Clinical Trials
55,089 Total Patients Enrolled
Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,177,102 Total Patients Enrolled
Rosemary White-Traut, PhD,RN,FAANPrincipal Investigator - Department of Nursing Research and Evidence-Based Practice Children's Wisconsin
Medical College of Wisconsin

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
~905 spots leftby Dec 2025
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