Phase 1
N=10
Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
Impaired Thermoregulation
Bottom Line
View on ClinicalTrials.gov: NCT01675830 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Head Wrap Feasibility — 100 percentage of respondents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Heat Retention Head Wrap (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Cardiology Clinical Research & Regulatory Group
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Head Wrap Feasibility |
100 | — |
| SECONDARY Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use |
— | — |
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.
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)
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.