NCT02415205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

3.7 years

First QC Date

April 9, 2015

Last Update Submit

December 13, 2018

Conditions

PainStress

Keywords

Pain and stress assessment in premature infants

Outcome Measures

Primary Outcomes (1)

  • Urine Stress Marker

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

    24 hours

Secondary Outcomes (2)

  • aEEG

    24 hours

  • NIRS

    24 hours

Eligibility Criteria

Age24 Weeks - 32 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Premature infants undergoing SOC ROP eye exams

You may qualify if:

  • Premature infants between 24 -32 weeks of gestational age

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Children's Hospital

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Andrew Hopper, MD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 14, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

US(1)