Status:
COMPLETED
Clinical Performance of the Embrace Isothermal Mattress
Lead Sponsor:
Stanford University
Conditions:
Hypothermia
Eligibility:
All Genders
1-120 years
Brief 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. ...
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 wean...
Eligibility Criteria
Inclusion
- Prematurity (27 to 34 weeks post-menstrual age at birth, 33 to 35 weeks post-menstrual age at screening)
- At risk for environmental hypothermia
- Cared for in an incubator
- Currently undergoing thermal weaning (no less than 72 hours prior to anticipated thermal weaning to transition to an open crib)
- Cardio-respiratory stability (as determined by physician/NNP)
- Written informed parental consent
Exclusion
- Continuing requirement of phototherapy
- Continuing requirement of assisted ventilation (e.g. CPAP)
- Cardio-respiratory instability (as determined by physician)
- Clinically-significant congenital abnormalities (as determined by PI)
- Acidosis or ongoing sepsis
- Dehydration (defined by hypernatremia with serum sodium \> 150 meq/L)
- Any additional concurrent high risk medical/surgical condition (as determined by physician, NNP or PI)
- Refusal of participation by parents -
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01425086
Start Date
March 1 2011
End Date
December 31 2012
Last Update
October 9 2017
Active Locations (1)
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1
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304