N/A
Completed N=20
Training in Exercise Activities and Motion for Growth
Single Ventricle Physiology
Source: ClinicalTrials.gov NCT01917084 ↗
Enrolled (actual)
20
Serious AEs
15.0%
Results posted
Jan 2021
Primary outcomePrimary: Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology — 11; 1; 0 events
Summary
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events (AEs) and Serious Adverse Events (SAEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology |
11; 1; 0 | — |
| PRIMARY Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology |
88; 2; 10 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) in a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized infants with SV physiology
- >37 weeks gestation
- <30 days of age
- Hemodynamically stable (as defined by the attending physician) after surgical or interventional palliation with closed sternum
- Parent or guardian willing to comply with protocol and provide written informed consent
Exclusion Criteria
- Intrauterine growth restriction
- Chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (for example Trisomy, Noonan or Turner syndromes)
- Unstable hemodynamics as defined by the attending physician
- Non-cardiac diagnosis associated with growth failure
- Severe neurologic injury resulting from stroke or intracranial hemorrhage confirmed by head CT/ MRI or cranial ultrasound
- Anticipated discharge within 14 days of screening
Data sourced from ClinicalTrials.gov (NCT01917084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.