- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00921544
Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening
June 15, 2009 updated by: Coombe Women and Infants University Hospital
Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial
Retinopathy of Prematurity (ROP) screening is one of many potentially painful diagnostic and therapeutic procedures performed routinely on preterm infants in the Neonatal Intensive Care Unit.
Therefore strategies for stress reduction and pain management are essential to promote growth and development and minimize long-term sequelae.
Procedural analgesia should include concepts of developmental care, non nutritive suck (NNS), pharmacological and non-pharmacological agents.
Sucrose is thought to stimulate the body's activation of lingual sweet taste receptors and release of endogenous opioids, when combined with NNS, non-opioid mechanisms are also activated.
The administration of sucrose or the combination of sucrose and non-nutritive sucking is one of the most frequently studied non-pharmacological interventions for relief of pain in neonates and oral sucrose has been shown to be an effective and safe therapy for common neonatal procedures such as heal lance, blood-letting and venepuncture.
There is conflicting evidence on the benefit of sucrose in ROP screening.
Therefore the purpose of this study is to determine the efficacy of sucrose combined with NNS as a potential regime for reduction of pain associated with retinopathy of prematurity screening.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dublin, Ireland, 8
- Coombe Women and Infants University Maternity Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- < 1500 grams
- < 32 weeks
Exclusion Criteria:
- Requiring mechanical ventilation excluding Continuous Positive Pressure Ventilation (CPAP), sedation
- Infants where consent to participate was not obtained
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Oral Sucrose
Oral sucrose administered 2 mins prior to eye exam
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0.2 ml sucrose 24% given by mouth using a syringe and pacifier
Other Names:
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Placebo Comparator: Sterile water
0.2 mls of sterile water
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Sterile water administered 2 mins prior to eye exam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain profile score as assessed by NPASS
Time Frame: Scores assessed 3 months following completion of study
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Scores assessed 3 months following completion of study
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of adverse events
Time Frame: Assessed 3 months following completion
|
Assessed 3 months following completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Eugene Dempsey, MD, FRCPI, Coombe Women and Infants University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
June 10, 2009
First Submitted That Met QC Criteria
June 15, 2009
First Posted (Estimate)
June 16, 2009
Study Record Updates
Last Update Posted (Estimate)
June 16, 2009
Last Update Submitted That Met QC Criteria
June 15, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Coombesucrose
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinopathy of Prematurity
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BayerRegeneron PharmaceuticalsCompletedAflibercept for Retinopathy of Prematurity - Intravitreal Injection Versus Laser Therapy (FIREFLEYE)Retinopathy of Prematurity (ROP)Spain, Singapore, Hong Kong, Korea, Republic of, Malaysia, Japan, Taiwan, Sweden, Portugal, Belgium, Argentina, Bulgaria, Italy, Austria, Brazil, Czechia, Greece, Hungary, Israel, Netherlands, Poland, Romania, Russian Federation, Slov... and more
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University Hospital FreiburgCompletedRetinopathy of Prematurity (ROP)Germany
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Novartis PharmaceuticalsCompletedRetinopathy of Prematurity (ROP)United States, Austria, Belgium, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Malaysia, Romania, Russian Federation, Saudi Arabia, Slovakia, Taiwan, Turkey, United Kingdom, Lithuania, Estonia
-
ShireCompletedRetinopathy of Prematurity (ROP)United States, Italy, Netherlands, Poland, Sweden, United Kingdom
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NICHD Neonatal Research NetworkEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsTerminatedRetinopathy of Prematurity (ROP)United States
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Zagazig UniversityCairo UniversityRecruitingRetinopathy of Prematurity Both EyesEgypt
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ShireCompletedRetinopathy of Prematurity (ROP)United States, Italy, Netherlands, United Kingdom, Sweden, Poland
-
University Hospital FreiburgWithdrawn
-
BayerRegeneron PharmaceuticalsActive, not recruitingRetinopathy of Prematurity (ROP)Spain, Korea, Republic of, Singapore, Malaysia, Japan, Taiwan, Bulgaria, Italy, Argentina, Brazil, Czechia, Greece, Hungary, Israel, Netherlands, Portugal, Romania, Russian Federation, Slovakia, Sweden, Turkey, United Kingdom, Ukraine, Belgi...
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Georgetown UniversityCompleted
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