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OpenTrials
Completed

NCT Number: NCT02415205

Pain and Stress Assessment and ROP Screening

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress

Age range

24 week–32 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Primary outcomes

  1. Urine Stress Marker

    Time frame: 24 hours

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

Secondary outcomes

  1. aEEG

    Time frame: 24 hours

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

  2. NIRS

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Pain and Stress Assessment and ROP Screening Examination in Premature Infants

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 14, 2015
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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