PainNCT02415205
Pain and Stress Assessment and ROP Screening
An observational study of Pain and Stress, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 24 to 32 weeksHealthy volunteers can take part
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: Premature infants undergoing SOC ROP eye exams
Who may be able to join
- Premature infants between 24 -32 weeks of gestational age
Who cannot join
- 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%)
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University Children's Hospital
Loma Linda, California, 92354
About this study
Official title: Pain and Stress Assessment and ROP Screening Examination in Premature Infants
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.
- Keywords
- Pain and stress assessment in premature infants
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Stress Marker
Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.
Measured: 24 hours
Secondary outcomes (2)
aEEG
1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.
Measured: 24 hours
NIRS
1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danilyn Angeles, PhD, Loma Linda University
- Investigators
- Andrew Hopper, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415205
- Sponsor's protocol ID
- 5150005
- Status last verified
- Dec 2018
- First submitted
- 9 Apr 2015
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Stress Assessment and ROP Screening Examination in Premature Infants
- ClinicalTrials.gov ID
- NCT02415205
- Acronym / sponsor ID
- 5150005
- Keywords
- Pain and stress assessment in premature infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 24 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Premature infants undergoing SOC ROP eye exams
Key inclusion criteria (1 listed)
- Premature infants between 24 -32 weeks of gestational age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Urine Stress Marker
Time frame: 24 hours
Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.
2 secondary outcomes
aEEG
Time frame: 24 hours
NIRS
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Hopper, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Stress, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine Stress Marker (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.