Clinical Performance of the Embrace Isothermal Mattress

Not Recruiting

Trial ID: NCT01425086


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.

Official Title

Clinical Performance of the Embrace Isothermal Mattress in Stabilizing Temperatures of the Preterm Infants During Thermal Weaning

Stanford Investigator(s)


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 -


device: Embrace, PCM, warming blanket

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nathan Meng