Clinical Performance of the Embrace Isothermal Mattress
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Embrace, PCM, warming blanket
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Embrace Device; Embrace Isothermal Mattress; Embrace Blanket; PCM blanket
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Low birth weight neonates
      
Keywords: Incubator,; hypothermia,; preterm,; low-birthweight infants,; embrace device,; phase change materials; PCM