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

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Nemours Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01835392
First received: April 16, 2013
Last updated: January 5, 2017
Last verified: September 2016
  Purpose
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).

Condition Intervention
Heart Defects, Congenital Procedure: Remote Ischemic Preconditioning Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 150
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)
Arms Assigned Interventions
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
Other Names:
  • RIPC
  • Remote Ischemic Conditioning
Sham Comparator: Control
Placement of blood pressure cuff around leg without inflation for 40 minutes
Other: Control
Sham placement of blood pressure cuff without inflation
Other Name: Sham

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.

  Eligibility

Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835392

Locations
United States, Delaware
Nemours Cardiac Center Recruiting
Wilmington, Delaware, United States, 19803
Contact: Carol Prospero, BS    302-651-6686    cprosper@nemours.org   
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Christian Pizarro, MD Nemours
  More Information

Responsible Party: Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01835392     History of Changes
Other Study ID Numbers: 259980
Study First Received: April 16, 2013
Last Updated: January 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nemours Children's Clinic:
Remote ischemic preconditioning
Heart defects, congenital
cardiac surgery
Neurodevelopmental outcomes

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2017