Pain and Stress Assessment and ROP Screening

Pain Clinical Trial

Official title:

Pain and Stress Assessment and ROP Screening Examination in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415205
• Other study ID #: 5150005
• Status: Completed
• Start date: April 2015
• Est. completion date: December 2018

Study information

• Verified date: December 2018
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 24 Weeks to 32 Weeks

Eligibility

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%)

Related Conditions & MeSH terms

• Pain
• Stress

Locations

Country	Name	City	State
United States	Loma Linda University Children's Hospital	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine Stress Marker	Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.	24 hours
Secondary	aEEG	1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.	24 hours
Secondary	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