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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COMPLETED
42 participants
OBSERVATIONAL
2015-04-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound
* Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam
* Renal injury defined with plasma creatinine \> 1.5 mg/dL
* Severe cyanotic congenital heart disease
* Unstable respiratory distress (hypoxemia PaO2 \< 50 mm Hg or SpO2 \< 90%)
24 Weeks
32 Weeks
ALL
Yes
Sponsors
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Loma Linda University
OTHER
Responsible Party
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Danilyn Angeles, PhD
PhD
Principal Investigators
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Andrew Hopper, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University
Locations
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Loma Linda University Children's Hospital
Loma Linda, California, United States
Countries
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Other Identifiers
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5150005
Identifier Type: -
Identifier Source: org_study_id
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