Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-05-15
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Perinatal HIE
Newborns diagnosed with moderate or severe perinatal hypoxic-ischemic encephalopathy (HIE) who are undergoing therapeutic hypothermia will receive genome sequencing to identify co-morbid genetic conditions. Participants' genetic data will be analyzed for copy number variations (CNVs), single nucleotide variants (SNVs), and triplet repeat disorders per ACMG reporting standards.
Genome sequencing
Neonates enrolled in this study will undergo genome sequencing with parental controls as applicable.
Interventions
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Genome sequencing
Neonates enrolled in this study will undergo genome sequencing with parental controls as applicable.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with moderate or severe HIE, or HIE with seizures
* Undergoing total body cooling / therapeutic hypothermia
* Able to provide blood or buccal samples during birth hospitalization
* Admitted to Texas Children's Hospital Main, West, or Woodlands NICU
Exclusion Criteria
* Inability to collect sufficient neonatal blood samples (in some circumstances, a buccal swab may be used as backup)
0 Days
1 Year
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Responsible Party
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Seema Lalani
Professor
Locations
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Texas Children's Hospital
Houston, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-54168
Identifier Type: -
Identifier Source: org_study_id
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