Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass (NCT01675830) | Clinical Trial Compass
CompletedPhase 1
Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
United States10 participantsStarted 2011-11
Plain-language summary
This is a phase I descriptive pilot study to determine the feasibility of using the Heat Retention Head Wrap on infants during the re-warming period following cardio-pulmonary bypass.
Who can participate
Age range1 Day – 1 Year
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing CPB surgery.
* Weigh ≥ 3 and ≤ 10 kg.
* Cooled to 24-30 degrees Celsius.
* Head circumferences between 33-48 cm.
* Scalp free of skin lesions such as reddened areas, ulcerations, abrasions, burns, and hemangiomas.
Exclusion Criteria:
* Require cooling below 24 degrees Celsius at any point during CPB surgery.
* Weigh less than 3 kg or more than that 10kg.
* Are premature or \< 37 weeks corrected gestational age.
* Have a head circumference smaller than 33 cm or larger than 48 cm.
* Have a known or previously diagnosed neurological trauma, malignant hyperthermia, stroke, seizure, VP shunt, evidence of scalp lesions, or other known comorbidity.
* Have hair braided close to the scalp.
* Infants with known allergy or sensitivity to polyethylene terephthalate (known as Mylar)
What they're measuring
1
Head Wrap Feasibility
Timeframe: <12 hours
Trial details
NCT IDNCT01675830
SponsorCardiology Clinical Research & Regulatory Group