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

NCT ID: NCT01835392

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2018-01-31

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.

Conditions

Heart Defects, Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote Ischemic Preconditioning

Intervention Type: PROCEDURE

Lower limb ischemia/reperfusion cycles

Control

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

Group Type: SHAM_COMPARATOR

Control

Intervention Type: OTHER

Sham placement of blood pressure cuff without inflation

Interventions

Remote Ischemic Preconditioning

Lower limb ischemia/reperfusion cycles

Intervention Type: PROCEDURE

Control

Sham placement of blood pressure cuff without inflation

Intervention Type: OTHER

Other Intervention Names

RIPC; Remote Ischemic Conditioning; Sham

Eligibility Criteria

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nemours Children's Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Pizarro, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours

Locations

Nemours Cardiac Center

Wilmington, Delaware, United States

Countries

United States

Other Identifiers

259980

Identifier Type: -

Identifier Source: org_study_id