Trial Outcomes & Findings for Clinical Use of a New Neonatal MRI System (NCT NCT01801865)

NCT ID: NCT01801865

Last Updated: 2020-10-27

Results Overview

Any observed physical changes either related or not related to the MRI was recorded during and after scanning.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 657 participants
• Primary outcome timeframe: Day 1
• Results posted on: 2020-10-27

Participant Flow

The attending neonatologist determined whether the MRI scan was done with or without sedation. If possible, infants were scanned without sedation. Infants were prepared for the MRI exam by switching all monitoring devices over to MRI compatible monitors and provided with hearing protection.

Participant milestones

Measure	MRI for Neonates MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Overall Study STARTED	657
Overall Study COMPLETED	615
Overall Study NOT COMPLETED	42

Reasons for withdrawal

Measure	MRI for Neonates MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Overall Study Patients scanned on another MRI scanner	35
Overall Study Physician Decision	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	MRI for Neonates n=615 Participants MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Age, Categorical <=18 years	615 Participants n=615 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=615 Participants
Age, Categorical >=65 years	0 Participants n=615 Participants
Age, Continuous	18.25 days n=615 Participants
Sex: Female, Male Female	280 Participants n=615 Participants
Sex: Female, Male Male	335 Participants n=615 Participants
Anatomy scanned Abdomen	7 Participants n=615 Participants
Anatomy scanned Orbit/Face/Neck	7 Participants n=615 Participants
Anatomy scanned Pelvis and Extremity	2 Participants n=615 Participants
Anatomy scanned Brain and Chest	7 Participants n=615 Participants
Anatomy scanned Brain and Abdomen	2 Participants n=615 Participants
Anatomy scanned Brain	517 Participants n=615 Participants
Anatomy scanned Brain and Spine	41 Participants n=615 Participants
Anatomy scanned Spine	23 Participants n=615 Participants
Anatomy scanned Chest and Spine	1 Participants n=615 Participants
Anatomy scanned Chest	5 Participants n=615 Participants
Anatomy scanned Spine and Pelvis	2 Participants n=615 Participants
Anatomy scanned Pelvis	1 Participants n=615 Participants

PRIMARY outcome

Timeframe: Day 1

Population: All patients have undergone clinically indicated and ordered MRI's.

Any observed physical changes either related or not related to the MRI was recorded during and after scanning.

Outcome measures

Measure	MRI for Neonates n=615 Participants MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Number of Participants With Adverse Events as Observed During and After Scanning.	4 Participants

SECONDARY outcome

Timeframe: Day 1

Population: All patients have undergone clinically indicated and ordered MRI's.

These 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=615 Participants MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Each Infant's Baseline Measurement for Weight Will be Recorded to Ensure the Infant is Less Than 6 kg.	615 Participants

Adverse Events

MRI for Neonates

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MRI for Neonates n=615 participants at risk MRI GE OPTIMA MR430s with HDX/GE Electronics: MRI scan
Respiratory, thoracic and mediastinal disorders Respiration abnormal	0.33% 2/615 • Number of events 2 • 1 day
Respiratory, thoracic and mediastinal disorders Apneic attack	0.16% 1/615 • Number of events 1 • 1 day
Surgical and medical procedures Sedative therapy	0.16% 1/615 • Number of events 1 • 1 day

Additional Information

Dr. Beth Kline-Fath

Cincinnati Children's Hospital Medical Center

Phone: (513) 636-1856

Email: beth.kline-fath@cchmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place