Trial Outcomes & Findings for Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy (NCT NCT05130528)
NCT ID: NCT05130528
Last Updated: 2026-05-19
Results Overview
Feasibility will be defined as the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
6 months
Results posted on
2026-05-19
Participant Flow
11 infants recruited into the study.
Participant milestones
| Measure |
Usual Care
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
|
Sensorimotor Intervention
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
8
|
|
Overall Study
COMPLETED
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Usual Care
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
|
Sensorimotor Intervention
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Therapeutic Intervention Supporting Development From NICU to 6 Months for Infants Post Hypoxic-Ischemic Encephalopathy
Baseline characteristics by cohort
| Measure |
Usual Care
n=3 Participants
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
|
Sensorimotor Intervention
n=8 Participants
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=30 Participants
|
7 Participants
n=30 Participants
|
9 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
4 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
4 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=30 Participants
|
3 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
|
Diagnosis of hypoxic-ischemic encephalopathy
|
3 Participants
n=30 Participants
|
8 Participants
n=30 Participants
|
11 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 2 weeksFeasibility will be defined as the proportion of infants completing 2 assessments and 2 parent/therapist collaborative sensorimotor intervention sessions before Neonatal Intensive Care Unit discharge.
Outcome measures
| Measure |
Usual Care
n=3 Participants
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
|
Sensorimotor Intervention
n=8 Participants
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
|
|---|---|---|
|
Feasibility of the Neonatal Intensive Care Unit Component of the Intervention.
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 6 monthsFeasibility will be defined as the proportion of infants completing 80% or more of the recommended 10 sensorimotor intervention sessions.
Outcome measures
| Measure |
Usual Care
n=3 Participants
Infants randomly assigned to this arm will not receive any study intervention but will continue with any intervention in the community recommended by their health care team.
|
Sensorimotor Intervention
n=8 Participants
Infants randomly assigned to this arm will participate in the sensorimotor intervention starting in the hospital and lasting for 6 months. This intervention includes 10 visits with a physical or occupational therapist and parent working together to advance an intervention program and 6 months of parent daily intervention. In addition, this arm will continue with any intervention in the community recommended by their health care team.
|
|---|---|---|
|
Feasibility of the Entire Sensorimotor Intervention.
|
0 Participants
|
0 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sensorimotor Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stacey Dusing, PhD, PT, FAPTA
University of Southern California
Phone: (323) 442-0191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place