Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants|
- neurodevelopmental outcomes [ Time Frame: at 6 month corrected age ] [ Designated as safety issue: No ]Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
- neurodevelopment [ Time Frame: at 15 weeks corrected age ] [ Designated as safety issue: No ]Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Formula or Breast Milk
Breast milk or formula prior to every painful procedure.
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
Other Name: sucrose 24%
Active Comparator: 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
Drug: multiple doses of sucrose
unlimited number of doses par day- current status in our NICU
Other Name: sucrose 24%
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742520
|Sheba Medical Center|
|Ramat Gan, Israel|
|Principal Investigator:||Iris Morag, M.D||Sheba Medical Center|