Sucrose Analgesia for the Reduction of Pain During Retinopathy of Prematurity Screening

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Sucrose and Non Nutritive Suck as Analgesia for Babies Undergoing Retinopathy of Prematurity Screening; a Randomised Placebo Controlled Trial

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Other: Sucrose
* Other: Sterile water


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral Sucrose<br>Oral sucrose administered 2 mins prior to eye exam | Other: Sucrose<br>* 0.2 ml sucrose 24% given by mouth using a syringe and pacifier<br>* Other names: Sweeties;|
| Placebo Comparator: Sterile water<br>0.2 mls of sterile water | Other: Sterile water<br>* Sterile water administered 2 mins prior to eye exam<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain profile score as assessed by NPASS |  | Scores assessed 3 months following completion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Assessed 3 months following completion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ROP, sucrose, pain