Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%

Study Overview
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Brief Summary
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The purpose of this study is to determine the effect of sucrose 24% for pain prevention on preterm infants. Our hypothesis is that repeated doses of sucrose 24%, given prior to painful procedure,do not impair neurodevelopmental outcomes of preterm infants

Detailed Description
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preterm infants born at 27-33 weeks gestational age at Sheba Medical Center will be recruited for this study. Prior to invasive procedure infants will be treated with pacifier and swaddling as recommended by the American Academy of Pediatrics and Canadian Pediatric Society. Group 1.Will be treated with Sucrose 24% 0.1-0.5ml on the anterior pat of the tongue 1-3 min prior to invasive procedure. Group 2. Similar to group 1 but breast milk or formula will replace Sucrose. Number of invasive procedures/day will be documented General Movements by Prechtel will be used for developmental assessment at 2,4,6 weeks after birth and at 14-16 weeks corrected age Griffiths developmental scales (GMDS) will be used at 40 weeks, 14-16 weeks corrected age, and 3-6 month corrected age

Official Title
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Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants

Conditions
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Development

Intervention / Treatment
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* Drug: multiple doses of sucrose
* Drug: Formula or breast milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preterm infants born at SMC Exclusion Criteria: need for intubation surgery need for sedation abnormal head ultrasound genetic abnormalities necrotizing enterocolitis other painful conditions other than routine blood exams

Ages Eligible for Study
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Minimum Age: 27 Weeks
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Formula or Breast Milk<br>Breast milk or formula prior to every painful procedure. | Drug: Formula or breast milk<br>* 1-3 minutes prior to every painful procedure, breast milk or formula 0.5-1 ml will be given on the anterior part of the tongue<br>* Other names: sucrose 24%;|
| Active Comparator: Multiple doses of sucrose<br>Infants in this group will be treated with Sucrose 24% 0.5-1ml on the anterior pat of the tongue 1-3min prior to every invasive procedure | Drug: multiple doses of sucrose<br>* unlimited number of doses par day- current status in our NICU<br>* Other names: sucrose 24%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopmental outcomes | Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel | at 6 month corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neurodevelopment | Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel | at 15 weeks corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preterm infant, pain, neurodevelopment