NCT01742520

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 27 Weeks – 33 Weeks
• Healthy volunteers: Accepted

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

Conditions

• Development

Interventions

Type	Name	Description
DRUG	multiple doses of sucrose	unlimited number of doses par day- current status in our NICU
DRUG	Formula or breast milk	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

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2015-06-01
• First posted: 2012-12-05
• Last updated: 2013-06-11

Locations

1 site across 1 country: Israel