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

Not Applicable

Completed

• Conditions: Heart Defects, Congenital
• Interventions: Procedure: Remote Ischemic Preconditioning; Other: Control

• Registration Number: NCT01835392
• Lead Sponsor: Nemours Children's Clinic

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2013-04-16
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Status Verified: 2016-09
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

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

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Exclusion Criteria

• Presence of known gross neurologic abnormality preoperatively
• History of birth asphyxia
• Non-English speaking family

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote Ischemic Preconditioning	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.
Control	Control	Placement of blood pressure cuff around leg without inflation for 40 minutes

Primary Outcome Measures

Name	Time	Method
Neurodevelopment	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

Trial Locations

Locations (1)

Nemours Cardiac Center; 🇺🇸 Wilmington, Delaware, United States