- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01835392
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Delaware
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Wilmington, Delaware, Förenta staterna, 19803
- Nemours Cardiac Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
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Lower limb ischemia/reperfusion cycles
Andra namn:
|
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Sham Comparator: Control
Placement of blood pressure cuff around leg without inflation for 40 minutes
|
Sham placement of blood pressure cuff without inflation
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Neurodevelopment
Tidsram: 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
|
12 months of age
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Christian Pizarro, MD, Nemours
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 259980
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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