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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 belowSelect...
I was born prematurely, between 23-35 weeks of pregnancy.
Timeline
Screening ~ 3 weeks3 visits
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.
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.
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 moreSecondary 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 moreAwards & 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
2,051 Previous Clinical Trials
2,726,944 Total Patients Enrolled
Duke UniversityOTHER
2,452 Previous Clinical Trials
2,967,191 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.The study is looking at two groups of parents and infants: one group is receiving a family intervention called H-HOPE, and the other group is a comparison group. Both parents and infants must meet certain requirements to be eligible for either group. There are also requirements for hospital personnel involved in the study.I may be on oxygen or receiving treatment through an IV.You are a baby who is ready to interact with others. If you are a twin or part of a multiple birth, only one of you will be included in the study's analysis.Plans to be the parent or guardian of the participant.My health condition is currently stable.I am a parent or guardian, regardless of my relationship to the child.You must be at least 31-32 weeks past your last menstrual period.I was born prematurely, between 23-35 weeks of pregnancy.You have been on a breathing machine in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Pre H-HOPE Cohort
- Group 2: H-HOPE Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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