PrematureNCT07016984
Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening
A study testing standard phototherapy eye patches in people with Premature and Retinopathy of Prematurity, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
Trial summary
Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. Read more about this study
- Who is it for?
- Ages 21 days and older
- Conditions the study is for
- Premature, Retinopathy of Prematurity, Pain
- What is being tested?
- standard phototherapy eye patches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 10 Mar 2025
- 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 21 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gestational age ≤34 weeks
- Birth weight ≤1700 grams
- Parental consent to participate in the study
Who cannot join
- Required mechanical ventilation during the study period
- Had genetic disorders, heart disease, neurological or metabolic conditions, pulmonary anomalies, or ocular malformations
- Had any conditions affecting the stress response
- Were administered sedatives, muscle relaxants, corticosteroids, or analgesics
- Had major congenital anomalies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nisantasi University
Sariyer, İ̇stanbul, 34481742
About this study
Official title: Effect of Light Intensity Reduction During Mydriasis on the Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening
Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. This study aimed to investigate the effect of using a phototherapy eye mask during mydriasis on the comfort levels of premature infants.
Read the detailed description
Retinopathy of prematurity is a pathological condition affecting the developing retinal blood vessels in low birth weight premature infants and is one of the leading causes of childhood blindness. In recent years, advancements in neonatal intensive care in developing countries such as China, India, and Turkey have increased the survival rates of premature infants, consequently raising the number of infants requiring ROP screening examinations. Health Organization (WHO) recommends conducting the initial ROP examination before the infant is discharged from the hospital. However, ROP screening is a painful and stressful procedure that includes the administration of mydriatic agents, the insertion of a speculum to open the palpebral fissure, and scleral depression to visualize the retinal periphery. These interventions often result in discomfort and distress for the infant. Globally, most newborns admitted to neonatal intensive care units (NICUs) undergo repeated painful procedures. It is well-established that premature infants can perceive pain, and exposure to pain during the early stages of life may lead to long-term neurological consequences. In very preterm infants, early exposure to procedural pain has been associated with impaired cognitive development and reductions in frontal and parietal lobe volumes, brain size, white matter, and subcortical gray matter. Considering the frequency of painful interventions during hospitalization, gaining deeper insight into stress-inducing factors and exploring methods to enhance infant comfort is of great importance. Various non-pharmacological interventions-such as pacifiers, music, and oral sucrose-have been studied for their effectiveness in reducing pain and stress during ROP examinations. However, research evaluating the effect of minimizing light exposure during pupil dilation (mydriasis) is limited. Mydriatic eye drops, used to dilate the pupils for examination, are known to cause light sensitivity and photophobia. It is hypothesized that the increased light sensitivity resulting from pupil dilation before the examination contributes to infant discomfort and stress. Therefore, this study aims to investigate the effect of reducing light exposure-by applying eye patches during the mydriasis process-on the comfort levels of premature infants undergoing ROP screening.
- Conditions
- Premature, Retinopathy of Prematurity, Pain
- Being tested
- standard phototherapy eye patches
- Keywords
- infant comfort, Light Exposure, Mydriasis, Non-pharmacological intervention, Neonatal intensive care, Premature infants, Retinopathy of prematurity
- Medical subject headings
- Premature Birth, Retinopathy of Prematurity, Pain, Mydriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard phototherapy eye patchesOther
Following the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Active comparator | Following the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches. Receives: Other: standard phototherapy eye patches |
| Control Group | No intervention | During the ROP examination, no eye patching was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups
Statistically significant differences were observed in the total scores and all subdimensions of the PICS-alertness, calmness/agitation, crying (in non-ventilated infants), physical movement, muscle tone, facial movements, and average heart rate
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jan 2024
- Primary completion28 Feb 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Nisantasi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alev Sivasli, Istanbul Nisantasi University
- Investigators
- Zerrin Cigdem, Associate Professor, Study director, Topkapi University, Istanbul, TurkeyNurşah B Şamlıer, PhD, Principal investigator, Nisantasi University, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016984
- Sponsor's protocol ID
- Decision No:2023/44
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: They are fully familiar with the study in all its details, so I do not find it necessary to elaborate further in order to avoid wasting time.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Light Intensity Reduction During Mydriasis on the Comfort Level in Premature Infants Undergoing Retinopathy of Prematurity Screening
- ClinicalTrials.gov ID
- NCT07016984
- Acronym / sponsor ID
- Decision No:2023/44
- Conditions
- Premature, Retinopathy of Prematurity, Pain
- Keywords
- infant comfort, Light Exposure, Mydriasis, Non-pharmacological intervention, Neonatal intensive care, Premature infants, Retinopathy of prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul Nisantasi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 12 Jun 2025 (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.
Retinopathy of prematurity (ROP) screening is a routine yet painful procedure for premature infants, often necessitating pharmacological mydriasis. The associated light exposure due to dilated pupils can increase stress and reduce infant comfort. This study aimed to investigate the effect of using a phototherapy eye mask during mydriasis on the comfort levels of premature infants.
Detailed description
Retinopathy of prematurity is a pathological condition affecting the developing retinal blood vessels in low birth weight premature infants and is one of the leading causes of childhood blindness. In recent years, advancements in neonatal intensive care in developing countries such as China, India, and Turkey have increased the survival rates of premature infants, consequently raising the number of infants requiring ROP screening examinations. Health Organization (WHO) recommends conducting the initial ROP examination before the infant is discharged from the hospital. However, ROP screening is a painful and stressful procedure that includes the administration of mydriatic agents, the insertion of a speculum to open the palpebral fissure, and scleral depression to visualize the retinal periphery. These interventions often result in discomfort and distress for the infant. Globally, most newborns admitted to neonatal intensive care units (NICUs) undergo repeated painful procedures. It is well-established that premature infants can perceive pain, and exposure to pain during the early stages of life may lead to long-term neurological consequences. In very preterm infants, early exposure to procedural pain has been associated with impaired cognitive development and reductions in frontal and parietal lobe volumes, brain size, white matter, and subcortical gray matter. Considering the frequency of painful interventions during hospitalization, gaining deeper insight into stress-inducing factors and exploring methods to enhance infant comfort is of great importance. Various non-pharmacological interventions-such as pacifiers, music, and oral sucrose-have been studied for their effectiveness in reducing pain and stress during ROP examinations. However, research evaluating the effect of minimizing light exposure during pupil dilation (mydriasis) is limited. Mydriatic eye drops, used to dilate the pupils for examination, are known to cause light sensitivity and photophobia. It is hypothesized that the increased light sensitivity resulting from pupil dilation before the examination contributes to infant discomfort and stress. Therefore, this study aims to investigate the effect of reducing light exposure-by applying eye patches during the mydriasis process-on the comfort levels of premature infants undergoing ROP screening.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Active comparator | Other: standard phototherapy eye patchesFollowing the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches. |
| Control Group | No intervention | –During the ROP examination, no eye patching was applied. |
Who may qualify
- Ages
- 21 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age ≤34 weeks
- Birth weight ≤1700 grams
- Parental consent to participate in the study
Key exclusion criteria (5 listed)
- Required mechanical ventilation during the study period
- Had genetic disorders, heart disease, neurological or metabolic conditions, pulmonary anomalies, or ocular malformations
- Had any conditions affecting the stress response
- Were administered sedatives, muscle relaxants, corticosteroids, or analgesics
- Had major congenital anomalies
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 |
|---|---|---|
| standard phototherapy eye patchesFollowing the mydriasis procedure performed prior to ROP examination, the eyes were covered with these patches. | Other | Experimental Group |
Primary outcome
post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups
Time frame: 8 hours
Statistically significant differences were observed in the total scores and all subdimensions of the PICS-alertness, calmness/agitation, crying (in non-ventilated infants), physical movement, muscle tone, facial movements, and average heart rate
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 12 Jun 2025.
- Individual participant dataSharing planned: No. They are fully familiar with the study in all its details, so I do not find it necessary to elaborate further in order to avoid wasting time.
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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.
Zerrin Cigdem, Associate Professor study director
Topkapi University, Istanbul, Turkey
Nurşah B Şamlıer, PhD principal investigator
Nisantasi University, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard phototherapy eye patches in people with Premature and Retinopathy of Prematurity, run by Istanbul Nisantasi University at 1 site in Turkey (Türkiye).
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 5 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 12 Jun 2025. 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 Turkey (Türkiye). 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?
post-test total and subdimension scores from the Premature Infant Comfort Scale (PICS), along with the statistical comparisons between the two groups (time frame: 8 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 12 Jun 2025.