Trial Outcomes & Findings for Development of a MR Scanner Capable of Being Sited in a Neonatal Intensive Care Unit (NCT NCT02232009)

NCT ID: NCT02232009

Last Updated: 2019-01-30

Results Overview

Safety will be assessed based on the number of Adverse Events.

Recruitment status

TERMINATED

Study phase

Target enrollment

9 participants

Primary outcome timeframe

1 Day

Results posted on

2019-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	3.0 T Neonatal Scanner All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Overall Study STARTED	9
Overall Study COMPLETED	9
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	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Age, Categorical <=18 years	9 Participants n=9 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=9 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants
Sex: Female, Male Female	6 Participants n=9 Participants
Sex: Female, Male Male	3 Participants n=9 Participants
Region of Enrollment United States	9 participants n=9 Participants

PRIMARY outcome

Timeframe: 1 Day

Safety will be assessed based on the number of Adverse Events.

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Summary Rates of Adverse Events	1 number of occurrences

PRIMARY outcome

Timeframe: 1 Day

Number of subject whose images were rated as Evaluable

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Image Diagnostic Quality	9 Participants

SECONDARY outcome

Timeframe: 1 Day

Duration of MRI scan time for each subject

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
MRI Scan Time	57 minutes Standard Deviation 6.08

SECONDARY outcome

Timeframe: 1 day

User survey results on a scale from 1 to 5, where 1 = strongly disagree and 5 = strongly agree.

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Overall Experience With Neonatal MR Scanner Device Summary Like to use frequently	3.22 score on a scale Interval 1.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Unnecessarily complex	3.11 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Easy to Use	2.56 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Would need tech support to use	3.00 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Functions are well integrated	2.89 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Too much inconsistency	2.78 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Most people would learn quickly	3.00 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Cumbersome to use	3.0 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Felt confident using	3.0 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Needed to learn a lot before using	3.22 score on a scale Interval 2.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary System meets patients needs	3.56 score on a scale Interval 3.0 to 4.0
Overall Experience With Neonatal MR Scanner Device Summary Would recommend to others	3.44 score on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 1 day

Scores range from 1-Very Poor image quality to 5-Excellent image quality.

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Overall Image Quality 1-Very Poor	0 Frequency of ratings
Overall Image Quality 2-Poor	0 Frequency of ratings
Overall Image Quality 3-Neutral	3 Frequency of ratings
Overall Image Quality 4-Good	6 Frequency of ratings
Overall Image Quality 5-Excellent	0 Frequency of ratings

SECONDARY outcome

Timeframe: 1 Day

Change in temperature (Celsius) per subject.

Outcome measures

Outcome measures
Measure	3.0 T Neonatal Scanner n=9 Participants All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Subject Change in Temperature	-0.07 Degrees Celsius Standard Deviation 0.23

Adverse Events

3.0 T Neonatal Scanner

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	3.0 T Neonatal Scanner n=9 participants at risk All subjects who participate in this study will be scanned using the 3.0 T Neonatal MRI scanner. 3.0 T Neonatal MRI Scanner: Eligible subjects will undergo neonatal MRI scanning procedures.
Skin and subcutaneous tissue disorders Redness behind ears	11.1% 1/9 • Number of events 1

Additional Information

Yvonne Celestial

GE Healthcare

Phone: +33 130709133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place