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Exercise Therapy for Hypoplastic Left Heart Syndrome (T4G RCT Trial)
Phase 3
Recruiting
Research Sponsored by HealthCore-NERI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Hospitalized infants with HLHS or other single RV anomalies
Planned Norwood procedure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first
Awards & highlights
T4G RCT Trial Summary
This trial will test if a passive ROM exercise program can improve the movement of infants with HLHS and other single right ventricle anomalies following the Norwood procedure.
Who is the study for?
This trial is for hospitalized infants with heart conditions like HLHS or single right ventricle anomalies, who are full-term (>=37 weeks), under 30 days old, and scheduled for the Norwood procedure. Parents must agree to follow the study rules and give consent. Infants with very low birth weight, certain genetic syndromes, non-cardiac growth issues, those listed for a transplant or expected to be discharged within two weeks of screening can't join.Check my eligibility
What is being tested?
The TEAM 4 Growth RCT is testing a passive range of motion exercise therapy program on infants after they've had heart surgery called the Norwood procedure. It's designed to see if this therapy helps in their recovery and growth post-surgery.See study design
What are the potential side effects?
Since it involves gentle exercises done by a therapist without active effort from the infant, side effects might be minimal but could include mild discomfort or fatigue during or after therapy sessions.
T4G RCT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My infant is hospitalized with a single ventricle heart condition.
Select...
I am scheduled for a Norwood heart surgery.
Select...
I am less than 30 days old.
T4G RCT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months of age or superior cavopulmonary connection (scpc) evaluation clinic visit, whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
weight-for-age z-score
Secondary outcome measures
DXA
NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores
Tests of Infant Motor Performance (TIMP)
+2 moreT4G RCT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Passive range-of-motionExperimental Treatment1 Intervention
daily assisted exercise sessions lasting 15-20 minutes, conducted by trained physical therapists, for up to 21 days prior to hospital discharge, plus standard of care
Group II: Standard of careActive Control1 Intervention
standard of care at study site
Find a Location
Who is running the clinical trial?
HealthCore-NERILead Sponsor
72 Previous Clinical Trials
206,495 Total Patients Enrolled
Carelon ResearchLead Sponsor
73 Previous Clinical Trials
216,517 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,310,874 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My infant is hospitalized with a single ventricle heart condition.I am scheduled for a Norwood heart surgery.You are at least 37 weeks pregnant.My condition, not related to my heart, is causing growth issues.I have a genetic condition like Trisomy, Noonan, or Turner syndromes affecting my growth.You were born very small compared to other babies at the same stage of development.You are on the waiting list for a heart transplant.I am less than 30 days old.
Research Study Groups:
This trial has the following groups:- Group 1: Passive range-of-motion
- Group 2: Standard of care
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How often do patients report negative side effects from passive range of motion exercise therapy?
"There is available clinical evidence supporting the safety of passive range of motion exercise therapy, so it received a score of 3."
Answered by AI
Would it be easy for me to find a clinical trial location near me?
"The primary locations for this trial are Boston Children's Hospital, Children's Healthcare of Atlanta / Emory University, and Texas Children's Hospital / Baylor. Additionally, there are 10 other places where this trial is taking place."
Answered by AI
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