Neonatal warming mattress for Hypothermia

Phase-Based Estimates
1
Effectiveness
1
Safety
University ofOklahoma Health Sciences Center, Oklahoma City, OK
Hypothermia
Neonatal warming mattress - Device
Eligibility
< 65
Female
Eligible conditions
Hypothermia

Study Summary

This study is evaluating whether a new method of warming preterm babies may reduce the risk of hypothermia.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Neonatal warming mattress will improve 1 primary outcome and 11 secondary outcomes in patients with Hypothermia. Measurement will happen over the course of 3 minutes.

24 hours
Hypoglycemia (less than 30mg/dL in the first 24 hours)
Need for NICU admission (if applicable)
Temperature upon admission to the NICU (if required)
Temperature upon leaving the delivery room
3 minutes
Difference in temperature
Temperature at completion of resuscitation
Month 3
Composite neonatal morbidity (if applicable)
Highest bilirubin level
Hyperthermia (>37.5 degrees C) (if applicable)
Number of days in the NICU (if applicable)
Pulmonary hemorrhage (if applicable)
Respiratory support in the form of intubation or continuous positive airway pressure (if applicable)

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Intervention group

This trial requires 64 total participants across 2 different treatment groups

This trial involves 2 different treatments. Neonatal Warming Mattress is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Intervention groupIn the intervention group, the infant will be placed on the thermal mattress, then wrapped.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through hospital discharge up to 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through hospital discharge up to 3 months for reporting.

Closest Location

University ofOklahoma Health Sciences Center - Oklahoma City, OK

Eligibility Criteria

This trial is for female patients aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who have non-emergent cesarean deliveries (defined as at least 2 hours prior to planned cesarean)
Gestational age between 32 weeks and 0 days and 36 weeks and 6 days determined per usual clinical parameters

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of hypothermia?

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All three groups suffered severe physical symptoms due to hypothermia, and most groups also suffered mental dysfunction, but there were no specific characteristics for a diagnosis of hypothermia.

Unverified Answer

What is hypothermia?

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hypothermia can occur with any type of acute brain injury. The most common cause of acute hypothermia is direct brain injury and causes intracranial temperature reduction. Hypothermia is associated with increased mortality and morbidity, especially in neurologically compromised patients.

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Can hypothermia be cured?

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The possibility that hypothermia could lead to a cure is debatable. No current therapy cures hypothermia, and it is still debated whether hypothermia might be used cautiously to halt further neurological deterioration.

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What are common treatments for hypothermia?

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The most common treatments for hypothermia in children are cooling the core and keeping warm by evaporation, but not all of these treatments appear effective.

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How many people get hypothermia a year in the United States?

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A study of hospital emergency department visits from 1996 to 2000 found that the number of hypothermia events had decreased over time in the United States. The study also revealed that hypothermia events are usually caused by an unexpected illness or event, rather than one that is expected from a known cause.

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What causes hypothermia?

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Most cases of hypothermia are due to trauma, or extreme environmental hypoxia and hyperthermia. However, the condition can be due to infection, sepsis or other illnesses, and may be caused by genetic conditions.

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What is sterile polyethylene wrap?

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The new generation of sterile water-soluble wrap is very well tolerated. The reduction in the wound infection rate was significant using this new generation wrap. There is one concern that new generation wrap is not bioabsorbable, there is not clinical documentation of this aspect and we need more studies to confirm this concern.

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Is sterile polyethylene wrap typically used in combination with any other treatments?

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Sterilisation may be very valuable, if done properly, in preventing infections; however, there is no evidence of any benefit in applying it before any other treatments are used. It has no effect if used alone. In this setting, there is no evidence of a benefit.

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Have there been other clinical trials involving sterile polyethylene wrap?

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Results from a recent paper suggests that there are several possible advantages to using sterile polyethylene wrap for hypothermic patients. This will lower the chance of acquiring complications or the need for further surgery.

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Does hypothermia run in families?

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Hypocapnia due to hypothermia may have an effect in slowing the onset of conduction system dysfunction seen during acute hypothermia. Results from a recent paper support the current belief that hypothermia may have a genetic component. A family based study may help elucidate the mechanisms by which hypothermia alters conduction.

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Is sterile polyethylene wrap safe for people?

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Use of sterile polyethylene wrap overlying a nonsterile dressing is safe. However, because it does not completely seal, leaks may occur and a clean, nonsterile cover should be applied.

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Has sterile polyethylene wrap proven to be more effective than a placebo?

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Data from a recent study shows that a group of critically ill surgical patients who received a PEW wrapped in an opaque dressing had a higher survival rate than an equal duration of treatment cohort who received a single wrap.

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