Trial Outcomes & Findings for Otteroo Case Series (NCT NCT03502265)

Results Overview

observational scale of motor skills, change in percentile score from week 0 to week 12 for each child. Full percentile range is 0-100%. Change of 0 means no change in percentile score, change of 100 means child went from 0% to 100% or 100% to 0% which is the maximum possible change in percentile score. A positive change means the percentile increased, while a negative change means the percentile decreased.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

weeks 0 and 12

Results posted on

2021-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Otteroo Adjunct A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms. Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Otteroo Adjunct n=4 Participants A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms. Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Age, Continuous	403 days STANDARD_DEVIATION 353 • n=4 Participants
Sex: Female, Male Female	2 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=4 Participants
Region of Enrollment United States	4 Participants n=4 Participants
Alberta Infant Motor Scale	11 overall percentile score (range 0-100) n=4 Participants

PRIMARY outcome

Timeframe: weeks 0 and 12

observational scale of motor skills, change in percentile score from week 0 to week 12 for each child. Full percentile range is 0-100%. Change of 0 means no change in percentile score, change of 100 means child went from 0% to 100% or 100% to 0% which is the maximum possible change in percentile score. A positive change means the percentile increased, while a negative change means the percentile decreased.

Outcome measures

Outcome measures
Measure	Otteroo Adjunct n=4 Participants A single-subject research design will be used: measures of infant development will be collected across a 4-week baseline period (standard care), 4 weeks of intervention (standard care and Otteroo use), and a 4 weeks of reversal/retention period (standard care). There is only one arm due to the study design. It is a within-subjects comparison, not a between-subjects comparison of different study arms. Otteroo: Otteroo will be provided for 4 weeks of use, to supplement any standard care. Standard care is not provided.
Change in Alberta Infant Motor Scale	5 change in percentile Interval -5.0 to 25.0

Adverse Events

Otteroo Adjunct

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

Beth Smith

University of Southern California

Phone: 323-361-4670

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place