Clinical Performance of the Embrace Isothermal Mattress

Completed

Conditions studied: Hypothermia

In brief

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.

Key facts

Study ID

NCT01425086

Run by

Stanford University

People needed

36

Starts

2011-03-01

Expected to finish

2012-12-31

Last updated by the study team

2017-10-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 -

Where it is running

• Lucile Packard Children's Hospital — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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