Pain and Stress Assessment and ROP Screening | NCT02415205

Studies
Pain and Stress Assessment and ROP Screening

NCT02415205

Sponsor

Loma Linda University

Status

Completed

Last Update Posted

Dec 17, 2018Actual

Enrollment

42Actual

Phase

Not provided

Conditions

Pain
Stress

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Apr 9, 2015

First Submission Date that Met QC Criteria

Apr 13, 2015

First Posted Date

Apr 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 13, 2018

Last Update Posted Date

Dec 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Urine Stress Marker	Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.	24 hours

Secondary Outcomes

Measure	Description	Time Frame
aEEG	1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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%)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Weeks

Maximum Age

32 Weeks

Standard Ages

Child

Study Population

Premature infants undergoing SOC ROP eye exams

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrew Hopper, MD	Loma Linda University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Loma Linda University Children's Hospital		Loma Linda	California	92354	United States

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided