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

Not Applicable

• Conditions: Development
• Interventions: Drug: Formula or breast milk; Drug: multiple doses of sucrose

• Registration Number: NCT01742520
• Lead Sponsor: Sheba Medical Center

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-18
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Study Start: 2013-01
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-09
• Last Update Posted: 2013-06-11
• Primary Completion: 2014-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• preterm infants born at SMC

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Exclusion Criteria

• need for intubation
• surgery
• need for sedation
• abnormal head ultrasound
• genetic abnormalities
• necrotizing enterocolitis
• other painful conditions other than routine blood exams

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Formula or Breast Milk	Formula or breast milk	Breast milk or formula prior to every painful procedure.
Multiple doses of sucrose	multiple doses of sucrose	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

Primary Outcome Measures

Name	Time	Method
neurodevelopmental outcomes	at 6 month corrected age	Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel

Secondary Outcome Measures

Name	Time	Method
neurodevelopment	at 15 weeks corrected age	Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel