Pain and Stress Assessment and ROP Screening

Pain and Stress Assessment and ROP Screening Examination in Premature Infants

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 Overview

• Status: Completed
• Conditions: Pain; Stress

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Premature infants undergoing SOC ROP eye exams

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine Stress Marker	Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
aEEG	1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.	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	24 hours

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Andrew Hopper, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Pain and stress assessment in premature infants
• Other Study ID Numbers: 5150005