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
1 other identifier
interventional
90
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedJune 11, 2013
June 1, 2013
1.4 years
November 18, 2012
June 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neurodevelopmental outcomes
Griffith mental developmental scaled (gross and fine motor, language, performance, social) and General movements by Prechtel
at 6 month corrected age
Secondary Outcomes (1)
neurodevelopment
at 15 weeks corrected age
Study Arms (2)
Formula or Breast Milk
ACTIVE COMPARATORBreast milk or formula prior to every painful procedure.
Multiple doses of sucrose
ACTIVE COMPARATORInfants 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
Interventions
unlimited number of doses par day- current status in our NICU
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
Eligibility Criteria
You may qualify if:
- preterm infants born at SMC
You may not qualify if:
- need for intubation
- surgery
- need for sedation
- abnormal head ultrasound
- genetic abnormalities
- necrotizing enterocolitis
- other painful conditions other than routine blood exams
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
Related Publications (1)
Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
PMID: 12205254RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iris Morag, M.D
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Neonatologist
Study Record Dates
First Submitted
November 18, 2012
First Posted
December 5, 2012
Study Start
January 1, 2013
Primary Completion
June 1, 2014
Study Completion
June 1, 2015
Last Updated
June 11, 2013
Record last verified: 2013-06