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Pain and Stress Assessment and ROP Screening

Pain and Stress Assessment and ROP Screening Examination in Premature Infants

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02415205
Enrollment
42
Registered
2015-04-14
Start date
2015-04-30
Completion date
2018-12-31
Last updated
2018-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Stress

Keywords

Pain and stress assessment in premature infants

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.

Interventions

None listed

Sponsors

Loma Linda University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
Yes

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%)

Design outcomes

Primary

MeasureTime frameDescription
Urine Stress Marker24 hoursCollection to occur 3-4 hours before eye exam and 24 hours after the eye exam.

Secondary

MeasureTime frameDescription
aEEG24 hours1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.
NIRS24 hours1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026