Clinical Performance of the Embrace Isothermal Mattress

NCT01425086 | Completed DMC

• 2 other identifiers: SU-03222011-7607eProtocol 19750
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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. The investigators aim to study the Embrace Isothermal Mattress over a 24-hour period before the infant is transitioned out of the incubator.

Conditions

Hypothermia

Keywords

Incubator,; hypothermia,; preterm,; low-birthweight infants,; embrace device,; phase change materials; PCM

Outcome Measures

Primary Outcomes (1)

• Temperature Stability

  As monitored by ambient (environmental) temperature, infant's core and surface temperature

  48 hours

Secondary Outcomes (1)

• Safety assessment by absence of change in cardio-respiratory events

  48 hours

Study Arms (2)

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

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

Interventions

Embrace, PCM, warming blanket DEVICE

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".

Also known as: Embrace Device, Embrace Isothermal Mattress, Embrace Blanket, PCM blanket

Embrace blanket warming; Incubator temperature support

Eligibility Criteria

• Age: 1 Day - 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Low birth weight neonates

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 -

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Hypothermia; Premature Birth

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vinod K. Bhutani, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: August 24, 2011
• First Posted: August 29, 2011
• Study Start: March 1, 2011
• Primary Completion: December 20, 2012
• Study Completion: December 31, 2012
• Last Updated: October 9, 2017

Record last verified: 2017-10

Locations

US (1)