Infant, Newborn, DiseaseNCT04519060
Eye Shields for Infants After Dilated Exam
A study testing phototherapy eye shield in people with Infant, Newborn, Disease and Pain, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Infant, Newborn, Disease, Pain, Retinopathy of Prematurity
- What is being tested?
- phototherapy eye shield
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to Dec 2021
- Phase
- Interventional
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Chronological age 0-12 months
- Infants who require dilated eye exams
- Parent or legal guardian consent/permission granted
Who cannot join
- More than a two-week interval between dilated eye exams
- Prior or ongoing medical treatment or therapy for the eye(s)
- Functional blindness diagnosed by eye exam
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Maxine Ogbaa, BSN, 323-361-2531, mogbaa@chla.usc.edu
Heidi Machen, PHN, BSN, 323-361-2531, hmachen@chla.usc.edu
About this study
Official title: An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
The eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
Read the detailed description
Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
- Being tested
- phototherapy eye shield
- Keywords
- eye shield, eye protector, eye patch, eye mask, phototherapy
- Medical subject headings
- Disease, Pain, Retinopathy of Prematurity, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapy eye shieldDevice
Also called phototherapy eye protector, phototherapy eye mask
Phototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops.
| Study group | Role | What they receive |
|---|---|---|
| No eye shields after dilated eye exam | No intervention | Eye dilation for scheduled exam will be followed by routine clinical care. |
| Eye shields after dilated eye exam | Experimental | Eye dilation for scheduled exam will be followed by routine clinical care and the application of eye shields. They will be worn until four (4) hours after the last dose of dilating eye drops. Receives: Device: phototherapy eye shield |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stress events
The primary outcome will be measured by the count of apneas and bradycardias (stress events) experienced by the infant during the period of eye dilation without eye shields as compared to the total stress events experienced when dilated eyes are covered with eye shields.
Measured: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Secondary outcomes (1)
Number of stress events amongst covariates
The secondary outcome measure will be abstracted from covariate data (e.g., infant gestational age at birth, post-natal age, weight, and ventilation status) to assess the influence of covariables on the response to eye shields as an intervention to lessen stress and discomfort in hospitalized infants after dilated eye exam.
Measured: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start1 Feb 2021
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maxine Ogbaa, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519060
- Sponsor's protocol ID
- CHLA-20-00211
- Status last verified
- Mar 2021
- First submitted
- 17 May 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Eye-opener: The Impact of Eye Shields for Infants After Dilated Exam
- ClinicalTrials.gov ID
- NCT04519060
- Acronym / sponsor ID
- CHLA-20-00211
- Keywords
- eye shield, eye protector, eye patch, eye mask, phototherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- 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 eyes of hospitalized infants are often assessed by dilated exam, and there is evidence that infants experience post-exam stress. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
Detailed description
Neonatal eye examinations are the standard of best practice in pediatrics. In the acute clinical setting, infants' eyes are inspected for eye development, defect, and disease. There is anecdotal and clinical evidence that infants experience stress after eye dilation. Investigators will evaluate whether eye shields for infants after dilated eye exam lessen stress and discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No eye shields after dilated eye exam | No intervention | –Eye dilation for scheduled exam will be followed by routine clinical care. |
| Eye shields after dilated eye exam | Experimental | Device: phototherapy eye shieldEye dilation for scheduled exam will be followed by routine clinical care and the application of eye shields. They will be worn until four (4) hours after the last dose of dilating eye drops. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Chronological age 0-12 months
- Infants who require dilated eye exams
- Parent or legal guardian consent/permission granted
Key exclusion criteria (3 listed)
- More than a two-week interval between dilated eye exams
- Prior or ongoing medical treatment or therapy for the eye(s)
- Functional blindness diagnosed by eye exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phototherapy eye shieldAlso: phototherapy eye protector, phototherapy eye maskPhototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops. | Device | Eye shields after dilated eye exam |
Primary outcome
Number of stress events
Time frame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
The primary outcome will be measured by the count of apneas and bradycardias (stress events) experienced by the infant during the period of eye dilation without eye shields as compared to the total stress events experienced when dilated eyes are covered with eye shields.
1 secondary outcome
Number of stress events amongst covariates
Time frame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Infant, Newborn, Disease
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
Not yet recruitingObservational study
Multimodal Mechanical, Tissue, Architectural, and Histological Evaluation of the Bone and Sutures of the Parietal Bone in an Infant With Craniosynostosis.
Craniostenosis
RecruitingPhase 1
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency
Inherited Bone Marrow Failure Syndrome, Familial Platelet Disorder With Predisposition to Myeloid Malignancies
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Recruiting
Nutritional Maturity in Preterm Newborns (Premature Infant Oral Motor Intervention, PIOMI)
Preterm, Preterm Infant Development
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy eye shield in people with Infant, Newborn, Disease and Pain, run by Children's Hospital Los Angeles 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maxine Ogbaa, BSN (323-361-2531, mogbaa@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of stress events (time frame: 4-6 hours (from first dose of eye dilating medication to four hours after last dose)). 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 12 Mar 2021.