Pain During ROP ExamNCT02152046
ROP Screening: Comparison of Pain Using Two Eyelid Retractors
An observational study of Pain During ROP Exam, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population. Read more about this study
- Who is it for?
- Ages 23 to 37 weeks
- Conditions the study is for
- Pain During ROP Exam
- What is being tested?
- ROP exam with spring loaded retractor and ROP exam with screw retractor
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2014to 24 Jun 2024
- 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 23 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants, who need an ROP exam based on clinical indication.
Who may be able to join
- Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight
Who cannot join
- Neonates who are paralyzed or have a negative pain score
- Neonates undergoing an Avastin injection
- Neonates undergoing a Retcam exam
- Neonates transferred to another unit
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital-Oak Lawn
Oak Lawn, Illinois, 60453
About this study
Official title: Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam.
Read more
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
Read the detailed description
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. It is a vasoproliferative retinopathy that affects premature and low birth-weight infants. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Only two studies alluded to the impact of the eyelid speculum on the pain response and score. Specifically, Hered and Gyland, questioned whether the Alfonso, spring loaded, eyelid lid speculum due to its forceful opening of the eyelid causes more pain. However, no studies were found that included the type of eyelid speculum as a variable of study. In addition, no studies have compared the effect of different eyelid speculums on the pain response.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The investigators team recognizes that the insertion of the eyelid speculum causes a pain response in these infants and would like to determine if there is a difference in the level of that response between the two speculums.
The investigators study will test the difference in pain response when using either a spring loaded eyelid speculum or screw loaded speculum during an ROP exam on premature infants.
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
- Conditions
- Pain During ROP Exam
- Being tested
- ROP exam with spring loaded retractor, ROP exam with screw retractor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROP exam with spring loaded retractorProcedure or surgery
ROP exam with screw retractorProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Spring loaded retractor | The Alfonso Eyelid Speculum, newborn size Receives: Procedure: ROP exam with spring loaded retractor | |
| Screw retractor | Cook Eyelid Speculum, infant size Receives: Procedure: ROP exam with screw retractor |
What is being measured
The primary outcome is the main question the study is designed to answer.
N-PASS Score immediately after the second eye
With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.
Measured: 5 minutes
Secondary outcomes (2)
time it takes for neonates pain score to return to baseline or up to 5 minutes after the end of the exam
Time in seconds will be recorded via stopwatch for the entire eye exam, starting with the insertion of the eyelid speculum in the right eye and concluding when the eyelid speculum is removed from the left eyelid.
Measured: 5 minutes
Maximum pain score recorded
With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study start20 Jun 2014
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
Why it stopped: Medical Leave of Absence of the Principal Investigator and study team changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain During ROP ExamStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Debra L Skopec, RN, BSN, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152046
- Sponsor's protocol ID
- IRB00106968
- Other IDs
- 5823, K5900211
- Status last verified
- Jan 2025
- First submitted
- 29 May 2014
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
PubMed 19924132Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
PubMed 18165830
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors
- ClinicalTrials.gov ID
- NCT02152046
- Acronym / sponsor ID
- IRB00106968
- Conditions
- Pain During ROP Exam
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Medical Leave of Absence of the Principal Investigator and study team changes
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 20 Jun 2014 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 2 Jun 2014 (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.
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam.
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
Detailed description
Retinopathy of prematurity (ROP) is a major cause of blindness in the world. It is a vasoproliferative retinopathy that affects premature and low birth-weight infants. Initial ocular examinations of infants at risk for ROP are generally conducted between 4-6 weeks postnatally. These exams are vital to protect preterm infants from blindness, but these exams have been shown to cause pain in this population.
Only two studies alluded to the impact of the eyelid speculum on the pain response and score. Specifically, Hered and Gyland, questioned whether the Alfonso, spring loaded, eyelid lid speculum due to its forceful opening of the eyelid causes more pain. However, no studies were found that included the type of eyelid speculum as a variable of study. In addition, no studies have compared the effect of different eyelid speculums on the pain response.
Currently two speculums are utilized; the spring loaded Alfonso and the screw loaded Cook eyelid speculum. There is no schedule for who receives which speculum during their exam. The investigators team recognizes that the insertion of the eyelid speculum causes a pain response in these infants and would like to determine if there is a difference in the level of that response between the two speculums.
The investigators study will test the difference in pain response when using either a spring loaded eyelid speculum or screw loaded speculum during an ROP exam on premature infants.
The objective of this study is to evaluate the pain response in the neonatal population, 32 weeks or less, and less than or equal to 1500 grams, undergoing a retractor eye exam for retinopathy of prematurity (ROP) screening.
The primary study aim is to compare the N-PASS pain score between neonates who received a ROP eye exam with the spring loaded Alfonso and the screw loaded Cook eye speculums.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spring loaded retractor | – | Procedure: ROP exam with spring loaded retractorThe Alfonso Eyelid Speculum, newborn size |
| Screw retractor | – | Procedure: ROP exam with screw retractorCook Eyelid Speculum, infant size |
Who may qualify
- Ages
- 23 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants, who need an ROP exam based on clinical indication.
Key inclusion criteria (1 listed)
- Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight
Key exclusion criteria (4 listed)
- Neonates who are paralyzed or have a negative pain score
- Neonates undergoing an Avastin injection
- Neonates undergoing a Retcam exam
- Neonates transferred to another unit
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 |
|---|---|---|
| ROP exam with spring loaded retractor | Procedure or surgery | Spring loaded retractor |
| ROP exam with screw retractor | Procedure or surgery | Screw retractor |
Primary outcome
N-PASS Score immediately after the second eye
Time frame: 5 minutes
With each exam, an N-PASS score will be recorded: just prior to the start of the exam; between each eye; at the end of the exam and every minute for five minutes from the completion of the exam.
2 secondary outcomes
time it takes for neonates pain score to return to baseline or up to 5 minutes after the end of the exam
Time frame: 5 minutes
Maximum pain score recorded
Time frame: 5 minutes
Results and safety
The study was stopped early (reason given: Medical Leave of Absence of the Principal Investigator and study team changes). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Background: PubMed 19924132Hummel P, Lawlor-Klean P, Weiss MG. Validity and reliability of the N-PASS assessment tool with acute pain. J Perinatol. 2010 Jul;30(7):474-8. doi: 10.1038/jp.2009.185. Epub 2009 Nov 19.
- Background: PubMed 18165830Hummel P, Puchalski M, Creech SD, Weiss MG. Clinical reliability and validity of the N-PASS: neonatal pain, agitation and sedation scale with prolonged pain. J Perinatol. 2008 Jan;28(1):55-60. doi: 10.1038/sj.jp.7211861. Epub 2007 Oct 25.
Related trials for Pain During ROP Exam
Not yet recruitingPhase 1
Use of Intranasal Midazolam to Reduce Stress and Procedural Pain in Premature Infants During Routine ROP Examination.
Drug Safety
Recruiting
The Effect of Two Non-Pharmacological Methods on Pain During Retinopathy Examination
Retinopathy of Prematurity (ROP)
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.
Debra L Skopec, RN, BSN principal investigator
Wake Forest University Health Sciences
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 During ROP Exam, run by Wake Forest University Health Sciences 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 4 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: stopped early, as of the sponsor's last update on 23 Jan 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 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 was stopped early (reason given: Medical Leave of Absence of the Principal Investigator and study team changes). Results are not available in the source record.
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?
N-PASS Score immediately after the second eye (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152046, which also lists 2 linked publications.
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 23 Jan 2025.