Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Women's Studies |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/7/2017 |
| Start Date: | September 2011 |
| End Date: | December 2018 |
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).
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.
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.
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
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