Trial Outcomes & Findings for Clinical Use of a Neonatal MRI System (NCT NCT03476343)
NCT ID: NCT03476343
Last Updated: 2025-02-12
Results Overview
Any observed physical changes will be recorded during and after scanning
COMPLETED
NA
386 participants
Day 1
2025-02-12
Participant Flow
Participant milestones
| Measure |
MRI for Neonates
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Overall Study
STARTED
|
386
|
|
Overall Study
COMPLETED
|
374
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
MRI for Neonates
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Overall Study
Clinical exam moved to another scanner
|
7
|
|
Overall Study
Clinical order cancelled
|
4
|
|
Overall Study
Neonate did not settle down for the scan
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
MRI for Neonates
n=386 Participants
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Age, Categorical
<=18 years
|
386 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=386 Participants
|
|
Age, Continuous
|
20 days
n=386 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=386 Participants
|
|
Anatomy scanned
Brain
|
365 Participants
n=386 Participants
|
|
Anatomy scanned
Brain and Neonate Spine
|
2 Participants
n=386 Participants
|
|
Anatomy scanned
Chest
|
4 Participants
n=386 Participants
|
|
Anatomy scanned
Spine
|
14 Participants
n=386 Participants
|
|
Anatomy scanned
Whole Body
|
1 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Day 1Any observed physical changes will be recorded during and after scanning
Outcome measures
| Measure |
MRI for Neonates
n=374 Participants
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Number of Participants With Adverse Events as Observed During and After Scanning.
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1These measures will be used in order to facilitate future design of coils and transport tables for the customized MRI system.
Outcome measures
| Measure |
MRI for Neonates
n=374 Participants
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Each Infant's Baseline Measurement for Weight Will be Recorded.
|
2.92 kg
Interval 0.54 to 4.89
|
SECONDARY outcome
Timeframe: Day 1The anatomy used will be used in order to facilitate understand the need for specific coils for the customized MRI system.
Outcome measures
| Measure |
MRI for Neonates
n=374 Participants
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Each Infant's Anatomy Scanned Will be Obtained.
Brain
|
357 Participants
|
|
Each Infant's Anatomy Scanned Will be Obtained.
Brain and Neonate Spine
|
1 Participants
|
|
Each Infant's Anatomy Scanned Will be Obtained.
Chest
|
2 Participants
|
|
Each Infant's Anatomy Scanned Will be Obtained.
Spine
|
13 Participants
|
|
Each Infant's Anatomy Scanned Will be Obtained.
Whole Body
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1These measures will be used in conjunction with the weight at the time of scan to facilitate future design of coils and transport tables for the customized MRI system.
Outcome measures
| Measure |
MRI for Neonates
n=386 Participants
MRI
GE OPTIMA MR430s with HDx/GE Electronics: MRI scan
|
|---|---|
|
Baseline Measurement for Days Old Will be Recorded.
|
20 days
Interval 1.0 to 155.0
|
Adverse Events
MRI for Neonates
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Beth Kline-Fath
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place