- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01835392
Neuroprotective Effects of Remote Ischemic Preconditioning (RIPC) During Infant Cardiac Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Nemours Cardiac Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
Andre navne:
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Sham-komparator: Control
Placement of blood pressure cuff around leg without inflation for 40 minutes
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Sham placement of blood pressure cuff without inflation
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Neurodevelopment
Tidsramme: 12 months of age
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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
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12 months of age
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Christian Pizarro, MD, Nemours
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 259980
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Remote Ischemic Preconditioning
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Rennes University HospitalAfsluttet
-
The Hospital for Sick ChildrenAfsluttet
-
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