Phase 1 Completed N=10 Prevention

Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass

Impaired Thermoregulation

Source: ClinicalTrials.gov NCT01675830 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcomePrimary: Head Wrap Feasibility — 100 percentage of respondents

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Head Wrap Feasibility	100	—
SECONDARY Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use	—	—

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01675830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.