NCT04702373

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.

Trial Health

58
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2021

Typical duration for phase_3

Geographic Reach
2 countries

10 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3.8 years

First QC Date

December 3, 2020

Last Update Submit

July 2, 2024

Conditions

Congenital Heart Disease

Keywords

Norwoodhypoplastic left heart syndromesingle right ventriclepassive range-of-motion

Outcome Measures

Primary Outcomes (1)

  • weight-for-age z-score

    weight-for-age z-score

    4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

Secondary Outcomes (6)

  • length-for-age z-score

    4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

  • head circumference-for-age z-score

    4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

  • Neonatal Intensive Care Unit (NICU) Network Neurobehavioral Scale (NNNS) subdomain scores

    Post-operative day 21 or discharge, whichever comes first

  • Tests of Infant Motor Performance (TIMP)

    Time of discharge from hospital following Norwood Procedure, approximately 3-4 weeks

  • Tests of Infant Motor Performance (TIMP)

    4 months of age or superior cavopulmonary connection (SCPC) evaluation clinic visit, whichever comes first

  • +1 more secondary outcomes

Study Arms (2)

Passive range-of-motion

EXPERIMENTAL

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

Other: passive range of motion exercise therapy

Standard of care

NO INTERVENTION

standard of care at study site

Interventions

passive range of motion exercise therapyOTHER

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.

Passive range-of-motion

Eligibility Criteria

AgeUp to 35 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • hospitalized infants with HLHS or other single RV anomalies
  • \>=37 weeks gestation
  • \<=35 days of age
  • planned Norwood procedure (or hybrid leading to Norwood within 35 days)
  • parent or guardian willing to comply with protocol and provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Children's Healthcare of Atlanta / Emory University

Atlanta, Georgia, 30322, United States

Location

Riley Children's Hospital of Indiana

Indianapolis, Indiana, 46208, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02458, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45227, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19083, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Children's Hospital / Baylor

Houston, Texas, 77030, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84116, United States

Location

The Hospital For Sick Children

Toronto, OT, M5G1X8, Canada

Location

MeSH Terms

Conditions

Heart Defects, CongenitalHypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2020

First Posted

January 8, 2021

Study Start

February 23, 2021

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations

US(9)CA(1)