Impaired ThermoregulationPhase 1NCT01675830
Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
A Phase 1 study testing Heat Retention Head Wrap in people with Impaired Thermoregulation, run by Cardiology Clinical Research & Regulatory Group at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Impaired Thermoregulation
- What is being tested?
- Heat Retention Head Wrap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Mar 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the detailed description
According to the World Health Organization a body temperature of 36-36.5 degrees Celsius is mild hypothermia, 32-36 degrees Celsius is moderate hypothermia, and < 32 degrees Celsius is severe hypothermia.1 Hypothermia can be a major postoperative problem for infants undergoing cardio-pulmonary bypass (CPB) surgery. During CPB, patients are cooled to decrease metabolism and protect myocardium and brain. When the repair is completed, the patient is re-warmed as the temperature of blood in the bypass pump is gradually increased. However, after separation from the CBP pump, infants consistently experience a temperature drop of 2 to 5 degrees Celsius.
With head cooling heat dissipates more quickly than with any other body surface. As much as 60% of an infant's body heat can dissipate through an uncovered head, thus leaving patients at high risk for complications associated with hypothermia. The amount of heat lost to the environment by newborn infants has a great impact on mortality rates, growth, and energy maintenance. Major adverse effects from inadvertent hypothermia include myocardial ischemia, impaired coagulation, prolonged healing, surgical wound infections, and decreased postoperative comfort.
Nursing participation in the re-warming of patients during CPB surgery is a core intervention. According to recommendations for perioperative registered nurses the patient should be at or returning to normothermia at the conclusion of the immediate postoperative period. Current standards of care for re-warming after CPB do not include any particular type of head covering. Recently, a new head covering made of biaxial-oriented polyethylene terephthalate (boPET), called the Heat Retention Head Wrap, has been designed for use with infants to facilitate warming during the postoperative period (that begins during the re-warming phase of CBP). The purpose of this study will be to determine the feasibility of using the Heat Retention Head Wrap on infants during the re-warming period following CPB.
Specific Aims
- To describe the feasibility of placing a Heat Retention 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.
- To characterize the temperature progression from (1) the onset of re-warming, (2) removal of bypass cannulas, to (3) removal of the rectal temperature probe immediately before transfer from the OR to the CICU, and (4) upon arrival to the CICU.
- To identify and describe adverse events observed with use of the Heat Retention Head Wrap.
- Conditions
- Impaired Thermoregulation
- Being tested
- Heat Retention Head Wrap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat Retention Head WrapDevice
Applied to infant's heads during the rewarming phase of CBP surgery
| Study group | Role | What they receive |
|---|---|---|
| Head Retention Head Wrap device | Experimental | All subjects recieved the experimental intervention with the Heat Retention Head Wrap device for during the rewarming phase of cardiopulmonary bypass surgery. Receives: Device: Heat Retention Head Wrap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head Wrap Feasibility
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.
Measured: <12 hours
Secondary outcomes (1)
Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use
To identify and describe adverse events observed with use of the Thermoregulation Head Wrap.
Measured: These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Impaired ThermoregulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiology Clinical Research & Regulatory Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Sakakeeny, BSN, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675830
- Sponsor's protocol ID
- IRB-P00001161
- Status last verified
- Mar 2015
- First submitted
- 19 Jul 2012
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Retention Head Wrap Use for Re-warming of Infants Requiring Cardio-Pulmonary Bypass
- ClinicalTrials.gov ID
- NCT01675830
- Acronym / sponsor ID
- IRB-P00001161
- Conditions
- Impaired Thermoregulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cardiology Clinical Research & Regulatory GroupUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 26 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
According to the World Health Organization a body temperature of 36-36.5 degrees Celsius is mild hypothermia, 32-36 degrees Celsius is moderate hypothermia, and < 32 degrees Celsius is severe hypothermia.1 Hypothermia can be a major postoperative problem for infants undergoing cardio-pulmonary bypass (CPB) surgery. During CPB, patients are cooled to decrease metabolism and protect myocardium and brain. When the repair is completed, the patient is re-warmed as the temperature of blood in the bypass pump is gradually increased. However, after separation from the CBP pump, infants consistently experience a temperature drop of 2 to 5 degrees Celsius.
With head cooling heat dissipates more quickly than with any other body surface. As much as 60% of an infant's body heat can dissipate through an uncovered head, thus leaving patients at high risk for complications associated with hypothermia. The amount of heat lost to the environment by newborn infants has a great impact on mortality rates, growth, and energy maintenance. Major adverse effects from inadvertent hypothermia include myocardial ischemia, impaired coagulation, prolonged healing, surgical wound infections, and decreased postoperative comfort.
Nursing participation in the re-warming of patients during CPB surgery is a core intervention. According to recommendations for perioperative registered nurses the patient should be at or returning to normothermia at the conclusion of the immediate postoperative period. Current standards of care for re-warming after CPB do not include any particular type of head covering. Recently, a new head covering made of biaxial-oriented polyethylene terephthalate (boPET), called the Heat Retention Head Wrap, has been designed for use with infants to facilitate warming during the postoperative period (that begins during the re-warming phase of CBP). The purpose of this study will be to determine the feasibility of using the Heat Retention Head Wrap on infants during the re-warming period following CPB.
Specific Aims
- To describe the feasibility of placing a Heat Retention 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.
- To characterize the temperature progression from (1) the onset of re-warming, (2) removal of bypass cannulas, to (3) removal of the rectal temperature probe immediately before transfer from the OR to the CICU, and (4) upon arrival to the CICU.
- To identify and describe adverse events observed with use of the Heat Retention Head Wrap.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Head Retention Head Wrap device | Experimental | Device: Heat Retention Head WrapAll subjects recieved the experimental intervention with the Heat Retention Head Wrap device for during the rewarming phase of cardiopulmonary bypass surgery. |
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat Retention Head WrapApplied to infant's heads during the rewarming phase of CBP surgery | Device | Head Retention Head Wrap device |
Primary outcome
Head Wrap Feasibility
Time frame: <12 hours
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.
1 secondary outcome
Redness, Irritation, and/or Hyperthermia Due to Head Wrap Use
Time frame: These will be assessed upon admission to the CICU, and in 6 hour follow up increments until the last assessment at 72 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Sakakeeny, BSN principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heat Retention Head Wrap in people with Impaired Thermoregulation, run by Cardiology Clinical Research & Regulatory Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head Wrap Feasibility (time frame: <12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.