Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT (T4G RCT)
Primary Purpose
Congenital Heart Disease
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
passive range of motion exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion
Eligibility Criteria
Inclusion Criteria:
- hospitalized infants with HLHS or other single RV anomalies
- >=37 weeks gestation
- <30 days of age
- planned Norwood procedure
- parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria:
- birthweight <3rd percentile for gestational age
- chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)
- non-cardiac diagnosis associated with growth failures
- listed for cardiac transplant
- anticipated discharge within 14 days of screening
Sites / Locations
- Children's Healthcare of Atlanta / Emory UniversityRecruiting
- Riley Children's Hospital of IndianaRecruiting
- Boston Children's HospitalRecruiting
- University of MichiganRecruiting
- Cincinnati Children's Hospital Medical CenterRecruiting
- Children's Hospital of PhiladelphiaRecruiting
- Medical University of South CarolinaRecruiting
- Texas Children's Hospital / BaylorRecruiting
- Primary Children's HospitalRecruiting
- The Hospital For Sick ChildrenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Passive range-of-motion
Standard of care
Arm Description
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
standard of care at study site
Outcomes
Primary Outcome Measures
weight-for-age z-score
weight-for-age z-score
Secondary Outcome Measures
length-for-age z-score
length-for-age z-score
head circumference-for-age z-score
head circumference-for-age z-score
NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores
NNNS subdomain scores; some score ranges from 1-9, but depends on each score whether higher is good or bad--for example, higher attention score is good, higher stress abstinence is bad; the rest of the scores range from 0-1 (yes/no)
Tests of Infant Motor Performance (TIMP)
Tests of Infant Motor Performance (TIMP)
Tests of Infant Motor Performance (TIMP)
Tests of Infant Motor Performance (TIMP)
DXA
bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
Full Information
NCT ID
NCT04702373
First Posted
December 3, 2020
Last Updated
June 28, 2023
Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT04702373
Brief Title
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
Acronym
T4G RCT
Official Title
Training in Exercise Activities and Motion for Growth: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carelon Research
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase III randomized controlled trial of a passive ROM exercise program that will be performed in infants with HLHS and other single right ventricle anomalies following the Norwood procedure at PHN and Auxiliary Centers.
Detailed Description
Growth is often impaired in infants with congenital heart disease (CHD). Nutritional interventions, drug therapy and surgical palliation have had varying degrees of success in enhancing growth. Passive ROM has improved somatic growth in preterm infants and has been demonstrated in a previous Pediatric Heart Network (PHN) to be safe and feasible in neonate's post-Norwood procedure. Improved growth may also favorably impact neurodevelopment, behavioral state, and time to hospital discharge.
This study's objectives are to evaluate growth in infants with hypoplastic left heart syndrome (HLHS) or other single right ventricle (RV) anomalies after the Norwood procedure who are randomized to a passive range of motion (ROM) exercise program vs. standard of care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Norwood, hypoplastic left heart syndrome, single right ventricle, passive range-of-motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Passive range-of-motion
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
standard of care at study site
Intervention Type
Other
Intervention Name(s)
passive range of motion exercise therapy
Intervention Description
Systematic flexion-extension with gentle compression at the end of the movement is performed 10 times at the wrist, elbow, shoulder, ankle, knee, and hip joints. Ten repetitions of adduction-abduction are performed at the shoulder and hip joints.
Primary Outcome Measure Information:
Title
weight-for-age z-score
Description
weight-for-age z-score
Time Frame
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Secondary Outcome Measure Information:
Title
length-for-age z-score
Description
length-for-age z-score
Time Frame
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Title
head circumference-for-age z-score
Description
head circumference-for-age z-score
Time Frame
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Title
NICU Neonatal Neurobehavioral Scale (NNNS) subdomain scores
Description
NNNS subdomain scores; some score ranges from 1-9, but depends on each score whether higher is good or bad--for example, higher attention score is good, higher stress abstinence is bad; the rest of the scores range from 0-1 (yes/no)
Time Frame
Post-operative day 21 or discharge, whichever comes first
Title
Tests of Infant Motor Performance (TIMP)
Description
Tests of Infant Motor Performance (TIMP)
Time Frame
Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks
Title
Tests of Infant Motor Performance (TIMP)
Description
Tests of Infant Motor Performance (TIMP)
Time Frame
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
Title
DXA
Description
bone mineral density as measured by dual-energy X-ray absorptiometry (DXA) scan
Time Frame
4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first
10. Eligibility
Sex
All
Maximum Age & Unit of Time
29 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
hospitalized infants with HLHS or other single RV anomalies
>=37 weeks gestation
<30 days of age
planned Norwood procedure
parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria:
birthweight <3rd percentile for gestational age
chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan, or Turner syndromes)
non-cardiac diagnosis associated with growth failures
listed for cardiac transplant
anticipated discharge within 14 days of screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Miller
Phone
617-923-7747
Email
julie.miller2@carelon.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica E Teng, MPH
Email
jessica.teng@carelon.com
Facility Information:
Facility Name
Children's Healthcare of Atlanta / Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanelle Clark
Phone
404-256-2593
Email
clarkes@kidsheart.com
Facility Name
Riley Children's Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Riggins, NP
Phone
317-773-3039
Email
jriggins@iuhealth.org
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02458
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samantha Butler, PhD
Phone
617-355-7483
Email
Samantha.Butler@childrens.harvard.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Uzark, PhD, CPNP
Phone
734-615-9748
Email
karenu@med.umich.edu
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Justice, DNP, RN
Phone
513-636-6267
Email
lindsey.justice@cchmc.org
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19083
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donna Sylvester, BSN, BA
Phone
484-354-5385
Email
sylvesterd@email.chop.edu
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frances Woodard, PNP
Phone
843-792-3292
Email
klinefl@musc.edu
Facility Name
Texas Children's Hospital / Baylor
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rocky Tsang, MD
Phone
832-826-6251
Email
rxtsang@texaschildrens.org
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84116
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Lambert, MSN-cFNP
Phone
801-587-7523
Email
linda.lambert@hsc.utah.edu
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
OT
ZIP/Postal Code
M5G1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bainton, JB, RN
Phone
(416) 813-7616
Email
jessica.bainton@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Joelene Huber, MD
Phone
(416) 813-7616
Email
joelene.huber@sickkids.ca
12. IPD Sharing Statement
Learn more about this trial
Training in Exercise Activities and Motion for Growth (TEAM 4 Growth) RCT
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