Evaluation of a PCM Mattress to Treat HIE Infants During Transport

Summary

Background the research proposed herein is in line with the Swedish Research Council's current focus on International collaborations and postdoctoral work abroad. In this case the child brain and translational and clinical infant brain research. Neonatal hypoxic ischemic encephalopathy in term infants constitutes a serious health problem, not the least due to its often life-long consequences in the form of cerebral palsy and other forms of brain dysfunction.

An estimated 3-5 of every 1000 live term births are affected, a quarter of which with severe symptoms; 10-30% of the affected children do not survive, 30% suffer life-long disabilities. The incidence may be 10-fold higher in the developing world. In Sweden, an estimated 200 children are born each year with hypoxic ischemic asphyxia or oxygen deprivation during delivery of a severity necessitating treatment, in order to reduce future handicap. Not only the brain, but also other organs, such as the heart, liver or kidney can be damaged by hypoxic ischemia.

In clinical trials, proof has been obtained that cooling can have positive effects counteracting brain injury induced by oxygen deprivation (asphyxia). Recent research suggests that cooling may also have a positive effect in stroke during the pre-treatment/transportation to hospital phase.

PCM. A material with phase change properties (PCM) can be a chemical element, a solution or a substance with high melting energy. It melts/solidifies at a precise temperature and can store considerable amounts of energy (heat) before changing from one phase to another. The study group have used elements or solutions that change between solid and fluid phases within a narrow temperature interval. The most common use of PCM today is for energy storage, accomplished by having the PCM change between solid and fluid phases. Phase changes that include other PCMs, high temperatures and/or gas phases are less useful in medical applications due to the need of either large volumes in a low pressure setting or smaller amounts in a high pressure setting, increasing the risk for mistakes or secondary injury to medical staff or patients. For the clinical purposes of hypothermic treatment described here, the Glauber salt-based PCM in a mattress form developed by the applicant has near ideal properties; it is completely safe, does not cause over-cooling, can be reused many times, eliminates cooling fluctuations, is easy to handle and biodegradable.

Conditions

• Newborn Hypoxic-Ischemic Encephalopathy

Interventions

DEVICE

The NeoHilda Point of care method

This is a procedure that measures Lactate dehydrogenase in a fast and reliable way from only 10 microliter of blood. Using a small point of care card and a Smartphone for analysis.

PROCEDURE

Traditional evaluation

Traditional way of evaluation

Sponsors & Collaborators

• National Children's Hospital, Vietnam

  collaborator OTHER

• Calmark Sweden AB

  collaborator UNKNOWN

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Hugo Lagercrantz, Professor · Karolinska Institutet

• Khu TK Dung, Prof, Vdir. · National Hospital of Pediatrics

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Max Age

36 Hours

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-08-31

Primary Completion

2024-08-31

Completion

2025-03-01

Countries

• Vietnam

Study Locations