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

Nemours Children's Health

Status: Completed

Conditions: Heart Defects, Congenital

Treatments: Other: Control; Procedure: Remote Ischemic Preconditioning

Study type: Interventional

Funder types: Other

Identifiers

NCT01835392

259980

Details and patient eligibility

About

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).

Full 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.

Enrollment: 137 patients

Sex: All

Ages: 1 day to 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

137 participants in 2 patient groups

Remote Ischemic Preconditioning

Experimental group

Description:

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.

Treatment:

Procedure: Remote Ischemic Preconditioning

Control

Sham Comparator group

Description:

Placement of blood pressure cuff around leg without inflation for 40 minutes

Treatment:

Other: Control