Pain and Stress Assessment and ROP Screening

Loma Linda University42 enrolled

Overview

The study will measure the effects of eye exams on markers of stress in the urine. In addition, measurements will be taken to show the effects of stress on brain activity, O2 sats, and blood flow.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pain Stress

Eligibility

Sex: ALLMin age: 24 WeeksMax age: 32 WeeksHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Premature infants between 24 -32 weeks of gestational age Exclusion Criteria: * Infants scheduled for laser eye surgery on the day of the examination * 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%)

Locations (1)

Loma Linda University Children's Hospital

Loma Linda, California, United States

Outcomes

Primary Outcomes

Urine Stress Marker

Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.

Time frame: 24 hours

Secondary Outcomes

aEEG

1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.

Time frame: 24 hours

NIRS

1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam

Time frame: 24 hours

Data from ClinicalTrials.gov

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