Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-27 @ 8:26 AM
Study NCT ID:
NCT02415205
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2015-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain and Stress Assessment and ROP Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-13', 'studyFirstSubmitDate': '2015-04-09', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine Stress Marker', 'timeFrame': '24 hours', 'description': 'Collection to occur 3-4 hours before eye exam and 24 hours after the eye exam.'}], 'secondaryOutcomes': [{'measure': 'aEEG', 'timeFrame': '24 hours', 'description': '1 hour prior to the eye examination and will remain there until 24 hours after the end of the eye exam.'}, {'measure': 'NIRS', 'timeFrame': '24 hours', 'description': '1 hour prior to the eye exam and will be kept in place until 24 hours after the end of the eye exam'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pain and stress assessment in premature infants'], 'conditions': ['Pain', 'Stress']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '32 Weeks', 'minimumAge': '24 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Premature infants undergoing SOC ROP eye exams', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Premature infants between 24 -32 weeks of gestational age\n\nExclusion Criteria:\n\n* Infants scheduled for laser eye surgery on the day of the examination\n* Infants with intraventricular hemorrhage ≥ grade 3 (Papile classification) diagnosed by head ultrasound\n* Infants receiving the following medications: morphine, fentanyl, methadone, midazolam, lorazepam, muscle relaxants, phenobarbital, phenytoin, levetiracetam\n* Renal injury defined with plasma creatinine \\> 1.5 mg/dL\n* Severe cyanotic congenital heart disease\n* Unstable respiratory distress (hypoxemia PaO2 \\< 50 mm Hg or SpO2 \\< 90%)'}, 'identificationModule': {'nctId': 'NCT02415205', 'briefTitle': 'Pain and Stress Assessment and ROP Screening', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Pain and Stress Assessment and ROP Screening Examination in Premature Infants', 'orgStudyIdInfo': {'id': '5150005'}}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': "Loma Linda University Children's Hospital", 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Andrew Hopper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Danilyn Angeles, PhD', 'investigatorAffiliation': 'Loma Linda University'}}}}