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H-HOPE Intervention for Premature Infants
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Pre H-HOPE Cohort
- Group 2: H-HOPE Cohort
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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