Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
|Heart Defects, Congenital||Procedure: Remote Ischemic Preconditioning Other: Control|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery|
- Neurodevelopment [ Time Frame: 12 months of age ]Neurodevelopmental outcomes at 12 (+/- 1) months of age as measured by the Bayley Scales of Infant and Toddler Development, Third Edition and the Infant Development Inventory
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Remote Ischemic Preconditioning
Four 5-minute cycles of leg ischemia interspersed with 5-minute cycles of reperfusion using a blood pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure.
Procedure: Remote Ischemic Preconditioning
Lower limb ischemia/reperfusion cycles
Sham Comparator: Control
Placement of blood pressure cuff around leg without inflation for 40 minutes
Sham placement of blood pressure cuff without inflation
Other Name: Sham
The purpose of this study is to look at whether the use of a simple technique before surgery, which involves inflating a blood pressure cuff on the infant's leg, can improve development of language, motor and thinking skills at 12 months of age. Some research has found that a brief shortage of blood supply to an organ (such as a leg) at level that does not cause harm may help the body to tolerate a longer and more severe shortage of blood (for example, during surgery).
The Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)9 assesses the developmental functioning of infants and young children between the ages of 1 month and 42 months. Cognitive, language, and motor development are assessed through structured play activities. Social-emotional and adaptive functioning are assessed through parent questionnaires. Administration time is 45 - 60 minutes, depending on the child's performance and behavior. Psychometric properties are well defined and acceptable. Composite scores for cognitive, language, motor, social-emotional, and adaptive behavior are standardized with a mean of 100 and a standard deviation of 15.
The Infant Development Inventory (IDI)10 will also be used to assess neurodevelopmental functioning, based on parent report. Parents are asked to rate their child's developmental skills in five domains: social, self help, gross motor, fine motor and language. Administration time is approximately 10 minutes. Infants are categorized as delayed or not delayed for each of the five domains.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835392
|United States, Delaware|
|Nemours Cardiac Center||Recruiting|
|Wilmington, Delaware, United States, 19803|
|Contact: Carol Prospero, BS 302-651-6686 firstname.lastname@example.org|
|Principal Investigator:||Christian Pizarro, MD||Nemours|