Trial Outcomes & Findings for Pilot Study: Safety of a Customized MRI System for Neonatal Imaging (NCT NCT01522339)
NCT ID: NCT01522339
Last Updated: 2014-09-25
Results Overview
Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.
COMPLETED
NA
15 participants
Day 1
2014-09-25
Participant Flow
Patients, eligible to participate, were recruited from within the NICU beginning in February 2012 ending in April 2012.
All participants enrolled in the study, completed the study.
Participant milestones
| Measure |
Pilot Group
Patients who received an MRI.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study: Safety of a Customized MRI System for Neonatal Imaging
Baseline characteristics by cohort
| Measure |
Pilot Group
n=15 Participants
Patients who had an MRI in the NICU scanner.
|
|---|---|
|
Age, Categorical
<=18 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
.19 years
STANDARD_DEVIATION .09 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1Heart rate and oxygen saturation will be measured every 15+/- 5 minutes. The infants' temperatures will be taken immediately before the MRI and again immediately after the MRI. A physical exam will be performed both immediately before and immediately after the MRI to assess for any physical changes.
Outcome measures
| Measure |
Pilot Group
n=15 Participants
Patients who received an MRI on the NICU scanner.
|
|---|---|
|
Number of Participants With Adverse Events as Measured by Vital Signs, Change in Temperature, and Physical Exam
|
0 Adverse Events
|
SECONDARY outcome
Timeframe: Post MRI Scan for Each InfantPopulation: Number of NICU MRI Images with Equal or Better Quality than Adult Scanner Images
The following measures will be individually evaluated and compared to similar images previously acquired on an adult scanner: Overall Study Quality, Motion, Spatial Resolution, Signal to Noise, and Contrast.
Outcome measures
| Measure |
Pilot Group
n=15 Participants
Patients who received an MRI on the NICU scanner.
|
|---|---|
|
MRI Image Quality
|
15 Images
|
Adverse Events
Pilot Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pilot Group
n=15 participants at risk
Patients who had an MRI in the NICU scanner.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mild Desaturation
|
20.0%
3/15 • Number of events 3 • Patients were monitored for approximately 2 hours after the MRI for Adverse Events for skin changes due to the monitor leads.
Patients' vital signs (heart rate and oxygen saturation) were measured and recorded during the MRI. The physician present performed a physical exam immediately after the MRI to assess for any skin changes due to the MRI scan process.
|
|
Cardiac disorders
Drop in Heart Rate
|
6.7%
1/15 • Number of events 1 • Patients were monitored for approximately 2 hours after the MRI for Adverse Events for skin changes due to the monitor leads.
Patients' vital signs (heart rate and oxygen saturation) were measured and recorded during the MRI. The physician present performed a physical exam immediately after the MRI to assess for any skin changes due to the MRI scan process.
|
Additional Information
Jean Tkach
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place