Trial Outcomes & Findings for Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass (NCT NCT01675830)

Results Overview

To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

<12 hours

Results posted on

2015-03-31

Participant Flow

Participant milestones

Participant milestones
Measure	Head Wrap Device Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Head Wrap Device n=10 Participants Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	17.4 weeks n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: <12 hours

Population: Percentage of respondents that agree device is easy to use

To describe the feasibility of placing a Thermoregulation Head Wrap on the infant's head from the time the re-warming process begins to the time baby arrives in the Cardiac Intensive Care Unit (CICU) after transfer from the operating room. Likert scale items assessing feasibility of the head wrap will be completed by clinicians upon patient admission to CICU.

Outcome measures

Outcome measures
Measure	Head Wrap Device n=10 Participants Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
Head Wrap Feasibility	100 percentage of respondents

SECONDARY outcome

Timeframe: These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.

Population: Number of adverse events observed

To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.

Outcome measures

Outcome measures
Measure	Head Wrap Device n=10 Participants Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use	0 adverse events

Adverse Events

Head Wrap Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Sakakeeny

Boston Children's Hospital

Phone: 617-355-6369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place