Single Ventricle Physiology
Conditions
Keywords
Passive range of motion, Single ventricle, Infants, Congenital heart disease
Brief 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.
Detailed description
This is a non-randomized pilot study to evaluate the safety and feasibility of an exercise program in hospitalized infants with single ventricle physiology. Following the Norwood procedure, the intervention will be administered for up to 21 days or until discharge, whichever comes first. Data will be collected daily during hospitalization and at a follow-up visit at 3 months of age. Sources of data will include medical record review. Twenty subjects will be enrolled at three Pediatric Heart Network study sites (Utah Primary Children's Hospital, Children's Hospital of Philadelphia and Texas Children's Hospital). Subjects will be recruited following Institutional Review Board (IRB) approval at each institution and parental/legal guardian consent.
Interventions
OTHERPassive range of motion (ROM) exercise
After their Norwood surgery, stable subjects will undergo passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever comes first. Subjects will have completed the study after their anthropometric measurements are collected at 3 months of age
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Carelon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | during the intervention and for one hour afterwards, daily up to 21 days | * Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded * Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded * Number of Serious Adverse Events (SAEs) possibly or probably related to the intervention occurring at any time during the 21 day intervention period |
| Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | during intervention, up to 21 days | Percentage of days with high completion, medium completion, and low completion of the intervention: * High completion is defined as \>75% of the intervention * Medium completion is defined as 50-75% of the intervention * Low completion is defined as \<50% of the intervention Percentage of days with high/medium/low completion was then calculated across all participants and days |
| 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 | during the intervention and for one hour afterwards, daily up to 21 days | • Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Passive Range of Motion (ROM) Exercise A 10 - 15 minute passive range of motion (ROM) exercise program was administered daily during hospitalization for up to 21 days or until discharge (whichever came first).
Passive range of motion (ROM) exercise: After their Norwood surgery, stable subjects underwent passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever came first. Subjects completed the study after their anthropometric measurements were collected at 3 months of age | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Passive Range of Motion (ROM) Exercise |
|---|---|
| Age, Continuous | 8 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 20 |
| other Total, other adverse events | 5 / 20 |
| serious Total, serious adverse events | 3 / 20 |
Outcome results
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
* Number of adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded * Number of AEs that are possibly or probably related to the intervention occurring during and for one hour after the daily study intervention is concluded * Number of Serious Adverse Events (SAEs) possibly or probably related to the intervention occurring at any time during the 21 day intervention period
Time frame: during the intervention and for one hour afterwards, daily up to 21 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Passive Range of Motion (ROM) Exercise | 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 | Number of adverse events | 11 events |
| Passive Range of Motion (ROM) Exercise | 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 | Number of AEs that are possibly or probably relate | 1 events |
| Passive Range of Motion (ROM) Exercise | 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 | Number of SAEs possibly or probably related | 0 events |
Primary
Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology
Percentage of days with high completion, medium completion, and low completion of the intervention: * High completion is defined as \>75% of the intervention * Medium completion is defined as 50-75% of the intervention * Low completion is defined as \<50% of the intervention Percentage of days with high/medium/low completion was then calculated across all participants and days
Time frame: during intervention, up to 21 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Passive Range of Motion (ROM) Exercise | Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | High completion | 88 percent of days |
| Passive Range of Motion (ROM) Exercise | Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | Medium completion | 2 percent of days |
| Passive Range of Motion (ROM) Exercise | Feasibility of a Passive ROM Exercise Program, Administered up to 21 Days After the Norwood Procedure, in Infants With Single Ventricle Physiology | Low completion | 10 percent of days |
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
• Number of participants with adverse events (AE), of any type, occurring during and for one hour after the daily study intervention is concluded
Time frame: during the intervention and for one hour afterwards, daily up to 21 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Passive Range of Motion (ROM) Exercise | 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 participants |