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ROP Screening: Comparison of Pain Using Two Eyelid Retractors

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ClinicalTrials.gov Identifier: NCT02152046
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2014
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
Debra Skopec, Advocate Health Care

Tracking Information
First Submitted Date May 29, 2014
First Posted Date June 2, 2014
Last Update Posted Date January 24, 2019
Study Start Date June 2014
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2014)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02152046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 30, 2014)
  • 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 ]
    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.
  • Maximum pain score recorded [ 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 30, 2014)
Bradycardia [ Time Frame: 5 minutes ]
Episodes of bradycardia will be recorded during the eye exam
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title ROP Screening: Comparison of Pain Using Two Eyelid Retractors
Official Title Retinopathy of Prematurity Screening: Comparison of Pain Using Two Eyelid Retractors
Brief 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.

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 Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Preterm infants, who need an ROP exam based on clinical indication.
Condition Pain During ROP Exam
Intervention
  • Procedure: ROP exam with spring loaded retractor
  • Procedure: ROP exam with screw retractor
Study Groups/Cohorts
  • Spring loaded retractor
    The Alfonso Eyelid Speculum, newborn size
    Intervention: Procedure: ROP exam with spring loaded retractor
  • Screw retractor
    Cook Eyelid Speculum, infant size
    Intervention: Procedure: ROP exam with screw retractor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: May 30, 2014)
10
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Neonates who are born at less than or equal to 32 weeks gestation or are less than or equal to 1500 grams birth weight

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 23 Weeks to 37 Weeks   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02152046
Other Study ID Numbers K5900211
5823 ( Other Identifier: Advocate IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Debra Skopec, Advocate Health Care
Study Sponsor Advocate Health Care
Collaborators Not Provided
Investigators
Principal Investigator: Debra L Skopec, RN, BSN Advocate Health Care
PRS Account Advocate Health Care
Verification Date January 2019