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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Sucrose | Active Comparator | Oral sucrose administered 2 mins prior to eye exam |
|
| Sterile water | Placebo Comparator | 0.2 mls of sterile water |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sucrose | Other | 0.2 ml sucrose 24% given by mouth using a syringe and pacifier |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain profile score as assessed by NPASS | Scores assessed 3 months following completion of study |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Assessed 3 months following completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Dempsey, MD, FRCPI | Coombe Women and Infants University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coombe Women and Infants University Maternity Hospital | Dublin | Dublin | 8 | Ireland |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sterile water | Other | Sterile water administered 2 mins prior to eye exam |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073893 |
| Sugars |