Clinical trial NCT03640494: Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
Official title: Bedside Optical Retinal Assessment of Hypoxic Ischemic Encephalopathy in Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxic-Ischemic Encephalopathy
Keywords: Optical Coherence Tomography
Newborn
Infant
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2018-08-21
Enrollment: 57
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty-eight participants with a clinical diagnosis of hypoxic ischemic encephalopathy will be recruited and consented into this study from the patient populations of Duke University and the University of Utah neonatal intensive care nurseries.

Brief summary: The purpose of this study is to develop a novel noninvasive bedside optical coherence tomography (OCT) imaging technique in newborn infants with HIE that improves our ability to assess the range of retinal effects from HIE and to diagnose and monitor treatments of HIE.


Eligibility criteria: Inclusion Criteria:

Infants are eligible if:

* Admitted to the intensive care nursery, outborn or inborn, with a clinical diagnosis of HIE; and with the approval of the neonatologist
* A parent or legal guardian provides written informed consent

Exclusion Criteria:

Potentially eligible infants will be excluded if:

• Congenital or chromosomal anomaly that has a profound impact on brain or eye development (e.g. anencephaly, congenital cataract or Peter's anomaly) and infants for whom there has been a clinical decision to limit life support.

Primary outcomes:
measure: Retinal injury morphologies on optical coherence tomography
timeFrame: birth to 10 days
measure: Retinal nerve fiber layer thickness on optical coherence tomography
timeFrame: birth to 10 days
measure: Inner macular layer thickness on optical coherence tomography
timeFrame: birth to 10 days
measure: Clinical hypoxic ischemic encephalopathy score
timeFrame: birth to 6 hours
measure: MRI brain injury score
timeFrame: from 4 to 14 days after birth
Secondary outcomes:
measure: Total macular layer thickness on optical coherence tomography
timeFrame: birth to 9 weeks
measure: Center foveal thickness
timeFrame: birth to 9 weeks
measure: Center ellipsoid zone thickness
timeFrame: birth to 9 weeks
measure: pattern of MRI injury
timeFrame: from 4 to 14 days after birth
measure: Choroidal thickness on optical coherence tomography
timeFrame: birth to 9 weeks
measure: Optic nerve head morphology
timeFrame: birth to 9 weeks
measure: thickness of macular nerve fiber layer
timeFrame: birth to 9 weeks
measure: thickness of macular ganglion cell layer
timeFrame: birth to 9 weeks
measure: thickness of inner nuclear layer
timeFrame: birth to 9 weeks
measure: thickness of inner plexiform layer
timeFrame: birth to 9 weeks
measure: thickness of photoreceptor layer
timeFrame: birth to 9 weeks
measure: Longitudinal change in retinal injury morphologies on optical coherence tomography
timeFrame: birth to 9 weeks
measure: Longitudinal change in retinal nerve fiber layer thickness on optical coherence tomography
timeFrame: birth to 9 weeks
measure: Longitudinal change in inner macular layer thickness on optical coherence tomography
timeFrame: birth to 9 weeks
measure: Late clinical hypoxic ischemic encephalopathy score
timeFrame: 1 to 8 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Duke University
name: Cynthia Toth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tran-Viet D, Wong BM, Mangalesh S, Maldonado R, Cotten CM, Toth CA. HANDHELD SPECTRAL DOMAIN OPTICAL COHERENCE TOMOGRAPHY IMAGING THROUGH THE UNDILATED PUPIL IN INFANTS BORN PRETERM OR WITH HYPOXIC INJURY OR HYDROCEPHALUS. Retina. 2018 Aug;38(8):1588-1594. doi: 10.1097/IAE.0000000000001735.
citation: Mangalesh S, Tran-Viet D, Pizoli C, Tai V, El-Dairi MA, Chen X, Viehland C, Edwards L, Finkle J, Freedman SF, Toth CA. Subclinical Retinal versus Brain Findings in Infants with Hypoxic Ischemic Encephalopathy. Graefes Arch Clin Exp Ophthalmol. 2020 Sep;258(9):2039-2049. doi: 10.1007/s00417-020-04738-0. Epub 2020 May 29.