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Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery

This study is currently recruiting participants.
Verified September 2016 by Nemours Children's Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01835392
First Posted: April 18, 2013
Last Update Posted: January 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Nemours Children's Clinic
April 16, 2013
April 18, 2013
January 6, 2017
September 2011
December 2017   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01835392 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
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 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).

Neurodevelopmental Assessment:

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Heart Defects, Congenital
  • Procedure: Remote Ischemic Preconditioning
    Lower limb ischemia/reperfusion cycles
    Other Names:
    • RIPC
    • Remote Ischemic Conditioning
  • Other: Control
    Sham placement of blood pressure cuff without inflation
    Other Name: Sham
  • 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.
    Intervention: Procedure: Remote Ischemic Preconditioning
  • Sham Comparator: Control
    Placement of blood pressure cuff around leg without inflation for 40 minutes
    Intervention: Other: Control
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2018
December 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants <7 months of age
  • Undergoing open heart surgery
  • Written informed consent

Exclusion Criteria:

  • Presence of known gross neurologic abnormality preoperatively
  • History of birth asphyxia
  • Non-English speaking family
Sexes Eligible for Study: All
up to 6 Months   (Child)
No
United States
 
 
NCT01835392
259980
No
Not Provided
Plan to Share IPD: No
Nemours Children's Clinic
Nemours Children's Clinic
Not Provided
Principal Investigator: Christian Pizarro, MD Nemours
Nemours Children's Clinic
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP