Pain and Stress Assessment and ROP Screening

Completed

• Conditions: Pain; Stress

• Registration Number: NCT02415205
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-14
• Status Verified: 2018-12
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Last Update Submitted: 2018-12-13
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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%)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Urine Stress Marker	24 hours	Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.

Secondary Outcome Measures

Name	Time	Method
NIRS	24 hours	1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam
aEEG	24 hours	1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.

Trial Locations

Locations (1)

Loma Linda University Children's Hospital; 🇺🇸 Loma Linda, California, United States