Neurodevelopmental Outcomes of Preterm Infants Treated for Pain Management With Repeated Doses of Sucrose 24%
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|ClinicalTrials.gov Identifier: NCT01742520|
Recruitment Status : Unknown
Verified June 2013 by Dr. Iris Morag, Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : December 5, 2012
Last Update Posted : June 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Development||Drug: multiple doses of sucrose Drug: Formula or breast milk||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Its an Interventional Study That Will Evaluate the Effect of Different Doses of Sucrose 24% on Neurodevelopmental Outcome of Preterm Infants|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||June 2014|
|Estimated Study Completion Date :||June 2015|
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%
- neurodevelopmental outcomes [ Time Frame: at 6 month corrected age ]Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
- neurodevelopment [ Time Frame: at 15 weeks corrected age ]Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01742520
|Contact: Iris Morag, MDfirstname.lastname@example.org|
|Contact: Tzipi Strauss, MDemail@example.com|
|Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Contact: Iris Morag, MD +9725307170 firstname.lastname@example.org|
|Contact: Tzipora Strauss, MD +9725302227|
|Principal Investigator: Iris Morag, MD|
|Principal Investigator:||Iris Morag, M.D||Sheba Medical Center|