Pain and Stress Assessment and ROP Screening

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Pain Stress

Keywords

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Pain and stress assessment in premature infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%)

Minimum Eligible Age

24 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Danilyn Angeles, PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Other Identifiers

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5150005

Identifier Type: -

Identifier Source: org_study_id