NCT03476343

Brief Summary

The purpose of the present study is to continue clinical scanning on the NICU MRI with improved administrative processes and procedures, thereby making medically indicated, state of the art/high end MRI exams available to all infants treated at CCHMC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 13, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

4.3 years

First QC Date

March 19, 2018

Results QC Date

June 20, 2023

Last Update Submit

February 11, 2025

Conditions

NICU MRI

Keywords

NICUMRINeonatalCincinnati

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events as Observed During and After Scanning.

    Any observed physical changes will be recorded during and after scanning

    Day 1

Secondary Outcomes (3)

  • Each Infant's Baseline Measurement for Weight Will be Recorded.

    Day 1

  • Each Infant's Anatomy Scanned Will be Obtained.

    Day 1

  • Baseline Measurement for Days Old Will be Recorded.

    Day 1

Study Arms (1)

MRI for Neonates

EXPERIMENTAL

MRI

Device: GE OPTIMA MR430s with HDx/GE Electronics

Interventions

GE OPTIMA MR430s with HDx/GE ElectronicsDEVICE

MRI scan

MRI for Neonates

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any infant admitted to CCHMC
  • Have a medical condition for which an MRI exam is indicated, as determined by the attending neonatologist

You may not qualify if:

  • Infants too large to fit in the customized NICU MRI system comfortably (generally infants \> 6 kg)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NICU, Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (29)

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    PMID: 17261476BACKGROUND

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    PMID: 10828582BACKGROUND

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    PMID: 20225116BACKGROUND

  • Schweigmann G, Gassner I, Maurer K. Imaging the neonatal heart--essentials for the radiologist. Eur J Radiol. 2006 Nov;60(2):159-70. doi: 10.1016/j.ejrad.2006.07.017. Epub 2006 Aug 22.

    PMID: 16930906BACKGROUND

  • Barkovich AJ. MR imaging of the neonatal brain. Neuroimaging Clin N Am. 2006 Feb;16(1):117-35, viii-ix. doi: 10.1016/j.nic.2005.10.003.

    PMID: 16543088BACKGROUND

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    PMID: 19138830BACKGROUND

  • Saunders DE, Thompson C, Gunny R, Jones R, Cox T, Chong WK. Magnetic resonance imaging protocols for paediatric neuroradiology. Pediatr Radiol. 2007 Aug;37(8):789-97. doi: 10.1007/s00247-007-0462-9. Epub 2007 May 9.

    PMID: 17487479BACKGROUND

  • Mathur AM, Neil JJ, McKinstry RC, Inder TE. Transport, monitoring, and successful brain MR imaging in unsedated neonates. Pediatr Radiol. 2008 Mar;38(3):260-4. doi: 10.1007/s00247-007-0705-9. Epub 2007 Dec 19.

    PMID: 18175110BACKGROUND

  • Bluml S, Friedlich P, Erberich S, Wood JC, Seri I, Nelson MD Jr. MR imaging of newborns by using an MR-compatible incubator with integrated radiofrequency coils: initial experience. Radiology. 2004 May;231(2):594-601. doi: 10.1148/radiol.2312030166.

    PMID: 15128999BACKGROUND

  • Erberich SG, Friedlich P, Seri I, Nelson MD Jr, Bluml S. Functional MRI in neonates using neonatal head coil and MR compatible incubator. Neuroimage. 2003 Oct;20(2):683-92. doi: 10.1016/S1053-8119(03)00370-7.

    PMID: 14568444BACKGROUND

  • Foran AM, Fitzpatrick JA, Allsop J, Schmitz S, Franklin J, Pamboucas C, O'Regan D, Hajnal JV, Edwards AD. Three-tesla cardiac magnetic resonance imaging for preterm infants. Pediatrics. 2007 Jul;120(1):78-83. doi: 10.1542/peds.2006-3305.

    PMID: 17606564BACKGROUND

  • Groves AM, Chiesa G, Durighel G, Goldring ST, Fitzpatrick JA, Uribe S, Razavi R, Hajnal JV, Edwards AD. Functional cardiac MRI in preterm and term newborns. Arch Dis Child Fetal Neonatal Ed. 2011 Mar;96(2):F86-91. doi: 10.1136/adc.2010.189142. Epub 2010 Oct 21.

    PMID: 20971721BACKGROUND

  • Michael R. Potential of MR-imaging in the paediatric abdomen. Eur J Radiol. 2008 Nov;68(2):235-44. doi: 10.1016/j.ejrad.2008.07.017. Epub 2008 Oct 9.

    PMID: 18848412BACKGROUND

  • Rao P. Neonatal gastrointestinal imaging. Eur J Radiol. 2006 Nov;60(2):171-86. doi: 10.1016/j.ejrad.2006.07.021. Epub 2006 Sep 25.

    PMID: 16997526BACKGROUND

  • Riccabona M. Imaging of the neonatal genito-urinary tract. Eur J Radiol. 2006 Nov;60(2):187-98. doi: 10.1016/j.ejrad.2006.07.022. Epub 2006 Sep 7.

    PMID: 16959460BACKGROUND

  • Darge K, Jaramillo D, Siegel MJ. Whole-body MRI in children: current status and future applications. Eur J Radiol. 2008 Nov;68(2):289-98. doi: 10.1016/j.ejrad.2008.05.018. Epub 2008 Sep 16.

    PMID: 18799279BACKGROUND

  • Olsen OE. Practical body MRI-A paediatric perspective. Eur J Radiol. 2008 Nov;68(2):299-308. doi: 10.1016/j.ejrad.2008.06.034. Epub 2008 Sep 2.

    PMID: 18768278BACKGROUND

  • Seghier ML, Huppi PS. The role of functional magnetic resonance imaging in the study of brain development, injury, and recovery in the newborn. Semin Perinatol. 2010 Feb;34(1):79-86. doi: 10.1053/j.semperi.2009.10.008.

    PMID: 20109975BACKGROUND

  • Simbrunner J, Riccabona M. Imaging of the neonatal CNS. Eur J Radiol. 2006 Nov;60(2):133-51. doi: 10.1016/j.ejrad.2006.07.019. Epub 2006 Sep 14.

    PMID: 16973325BACKGROUND

  • Rutherford M, Srinivasan L, Dyet L, Ward P, Allsop J, Counsell S, Cowan F. Magnetic resonance imaging in perinatal brain injury: clinical presentation, lesions and outcome. Pediatr Radiol. 2006 Jul;36(7):582-92. doi: 10.1007/s00247-006-0164-8. Epub 2006 May 16.

    PMID: 16770663BACKGROUND

  • Bartha AI, Yap KR, Miller SP, Jeremy RJ, Nishimoto M, Vigneron DB, Barkovich AJ, Ferriero DM. The normal neonatal brain: MR imaging, diffusion tensor imaging, and 3D MR spectroscopy in healthy term neonates. AJNR Am J Neuroradiol. 2007 Jun-Jul;28(6):1015-21. doi: 10.3174/ajnr.A0521.

    PMID: 17569948BACKGROUND

  • Glass HC, Bonifacio SL, Sullivan J, Rogers E, Ferriero DM, Goldstein R, Barkovich AJ. Magnetic resonance imaging and ultrasound injury in preterm infants with seizures. J Child Neurol. 2009 Sep;24(9):1105-11. doi: 10.1177/0883073809338328.

    PMID: 19745086BACKGROUND

  • Prager A, Roychowdhury S. Magnetic resonance imaging of the neonatal brain. Indian J Pediatr. 2007 Feb;74(2):173-84. doi: 10.1007/s12098-007-0012-3.

    PMID: 17337831BACKGROUND

  • Roelants-van Rijn AM, Groenendaal F, Beek FJ, Eken P, van Haastert IC, de Vries LS. Parenchymal brain injury in the preterm infant: comparison of cranial ultrasound, MRI and neurodevelopmental outcome. Neuropediatrics. 2001 Apr;32(2):80-9. doi: 10.1055/s-2001-13875.

    PMID: 11414648BACKGROUND

  • Maalouf EF, Duggan PJ, Counsell SJ, Rutherford MA, Cowan F, Azzopardi D, Edwards AD. Comparison of findings on cranial ultrasound and magnetic resonance imaging in preterm infants. Pediatrics. 2001 Apr;107(4):719-27. doi: 10.1542/peds.107.4.719.

    PMID: 11335750BACKGROUND

  • Epelman M, Daneman A, Kellenberger CJ, Aziz A, Konen O, Moineddin R, Whyte H, Blaser S. Neonatal encephalopathy: a prospective comparison of head US and MRI. Pediatr Radiol. 2010 Oct;40(10):1640-50. doi: 10.1007/s00247-010-1634-6. Epub 2010 Apr 22.

    PMID: 20411255BACKGROUND

Related Links

Results Point of Contact

Title
Dr. Beth Kline-Fath
Organization
Cincinnati Children's Hospital Medical Center
beth.kline-fath@cchmc.org
(513) 636-1856

Study Officials

  • Beth M Kline-Fath, MD

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2018

First Posted

March 26, 2018

Study Start

February 11, 2018

Primary Completion

June 3, 2022

Study Completion

September 9, 2022

Last Updated

February 12, 2025

Results First Posted

February 13, 2024

Record last verified: 2025-02

Locations

US(1)