Clinical Performance of the Embrace Isothermal Mattress (KBW)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Stanford University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Vinod K. Bhutani, Stanford University
ClinicalTrials.gov Identifier:
NCT01425086
First received: August 24, 2011
Last updated: May 21, 2012
Last verified: May 2012
  Purpose

The purpose of this pilot study is to evaluate the performance of a new warming technology (Embrace Isothermal Mattress) during the thermal weaning of premature infants from incubators to open cribs. The investigators aim to study the Embrace Isothermal Mattress over a 24-hour period before the infant is transitioned out of the incubator.


Condition Intervention Phase
Hypothermia
Device: Embrace, PCM, warming blanket
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Clinical Performance of the Embrace Isothermal Mattress in Stabilizing Temperatures of the Preterm Infants During Thermal Weaning

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Temperature Stability [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    As monitored by ambient (environmental) temperature, infant's core and surface temperature


Secondary Outcome Measures:
  • Safety assessment by absence of change in cardio-respiratory events [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    As monitored by heart rate, respiratory rates, pulse-oximetry and occurrence of apnea events


Estimated Enrollment: 36
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Incubator temperature support
Infant will be cared for in the current ongoing policy-driven temperature support provided by the incubator and handling as per bedside nursing interventions. Infant will be followed clinically until discharge from Lucile Packard Hospital (average 4 weeks).
Device: Embrace, PCM, warming blanket
Infant will be placed on a blanket that encloses the Embrace device, The infant will be wrapped in this blanket to create a snug, comfortable and warm "micro-environment".
Other Names:
  • Embrace Device
  • Embrace Isothermal Mattress
  • Embrace Blanket
  • PCM blanket
Experimental: Embrace blanket warming
Infant will be placed and wrapped in the embrace blanket and cared for and monitored for temperature support and monitored by bedside nursing interventions, as needed. Infant will be followed clinically until discharge from Lucile Packard Hospital (average 4 week
Device: Embrace, PCM, warming blanket
Infant will be placed on a blanket that encloses the Embrace device, The infant will be wrapped in this blanket to create a snug, comfortable and warm "micro-environment".
Other Names:
  • Embrace Device
  • Embrace Isothermal Mattress
  • Embrace Blanket
  • PCM blanket

Detailed Description:

The investigators aim to use the results of this pilot study in preparation for a larger, longer, multi-center clinical trial testing the performance of the Embrace Isothermal Mattress during the weaning of premature infants from incubators to open cribs (thermal weaning). Specifically, this study would provide physiological data (e.g. temperature, weight) and operational experience (e.g. logistical issues, familiarity with technology) that would assess the short-term effectiveness (< 24 hours) of the new technology in maintaining temperature stability as well as informing the subsequent trial.

This study will build upon two primary bodies of scientific knowledge: (1) the applicability of an isothermal mattress as a supplemental heat source during thermal weaning and (2) basic clinical knowledge of the quality, quantity, and timing of warming during the thermal weaning process.

First, current thermal weaning processes at LPCH are heavily dependent upon prolonged use of incubators. Additional sources of warming include radiant warmers, transwarmers (e.g. one-time use gel-packs), skin-to-skin contact (e.g. Kangaroo Mother Care), and others. While all provide sufficient warming during thermal weaning but are not always ideal (e.g. incubators separate mother and baby, radiant warmer and transwarmers have varying abilities to stabilize temperature over prolonged periods, and skin-to-skin contact is not constantly available). In contrast, the Embrace Isothermal Mattress is based on a wax-like phase-change-material (PCM) that allows for an extremely stable long-term heat exchange with an infant. It was designed to function without a constant source of electricity and is relatively portable allowing for its use as a supplement to incubators, skin-to-skin contact, and other warming techniques.

Secondly, this study will inform future clinical practices specifically in thermal weaning and generally in neonatal temperature regulation. Thermal weaning occurs when the incubator's set temperature is incrementally lowered by nurses in preparation for a transition to an open crib. Eventually, a clinical decision is made to clothe the infant and turn off the incubator (based upon physiological markers and nursing experience). A period of observation of the clothed infant within the switched-off incubator (immediate to 12 hours based on a survey of LPCH nurses) then precedes transition to an open crib. A series of retrospective chart reviews has observed a range of thermal weaning practices between and within LPCH-affiliated nurseries possibly due to a wide interpretation of existing thermal weaning protocols (e.g. weaning at different post- menstrual ages, physiological characteristics, cognitive development). The investigators are hopeful that this study will provide additional scientific data to inform clinical decision-making during thermal weaning.

Ultimately, the research performed in this pilot study and subsequent clinical trial will determine whether the Embrace Isothermal Mattress may facilitate a more optimal transition of an infant from an incubator to an open crib. For example, if infants are found to transition effectively at lower body weight and post-menstrual age while still maintaining temperature stability while using the Embrace Isothermal Mattress, then clinicians can offer an alternative thermal weaning method with additional secondary benefits. Specifically, this early transition may facilitate earlier mother-child bonding and improve the infant's quality of life ultimately leading to a more advanced developmental stage upon discharge from the PICN. In addition, use of this new technology as an alternative for weaning may free incubators for more life-threatening cases, ultimately providing for more efficient and cost-effective use of PICN resources. Therefore, the end goal is to improve overall clinical practice and patient experience by introducing and evaluating a potentially beneficial warming technology.

  Eligibility

Ages Eligible for Study:   up to 120 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Prematurity (27 to 34 weeks post-menstrual age at birth, 33 to 35 weeks post-menstrual age at screening)
  2. At risk for environmental hypothermia
  3. Cared for in an incubator
  4. Currently undergoing thermal weaning (no less than 72 hours prior to anticipated thermal weaning to transition to an open crib)
  5. Cardio-respiratory stability (as determined by physician/NNP)
  6. Written informed parental consent

Exclusion Criteria:

  1. Continuing requirement of phototherapy
  2. Continuing requirement of assisted ventilation (e.g. CPAP)
  3. Cardio-respiratory instability (as determined by physician)
  4. Clinically-significant congenital abnormalities (as determined by PI)
  5. Acidosis or ongoing sepsis
  6. Dehydration (defined by hypernatremia with serum sodium > 150 meq/L)
  7. Any additional concurrent high risk medical/surgical condition (as determined by physician, NNP or PI)
  8. Refusal of participation by parents -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425086

Contacts
Contact: Vinod Bhutani, MD bhutani@stanford.edu

Locations
United States, California
Lucile Packard Children's Hospital Recruiting
Palo Alto, California, United States, 94304
Contact: Nathan Meng       natemeng@gmail.com   
Contact: Vinod K Bhutani, MD    650723-5711    bhutani@stanford.edu   
Sub-Investigator: Nathan Meng         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Vinod K. Bhutani, MD Stanford University
  More Information

No publications provided

Responsible Party: Vinod K. Bhutani, Professor of Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01425086     History of Changes
Other Study ID Numbers: SU-03222011-7607, eProtocol 19750
Study First Received: August 24, 2011
Last Updated: May 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Incubator,
hypothermia,
preterm,
low-birthweight infants,
embrace device,
phase change materials
PCM

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014