Evaluation of a PCM Mattress to Treat HIE Infants During Transport

NCT05361473 | Active Not Recruiting DMC

• 1 other identifier: PCMcooling test study Vietnam
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Asfyxia; HIE; Infections; Lactate dehydrogenase

Outcome Measures

Primary Outcomes (1)

• Patient classification/ window of oppertunity Hypothermia during transport or start late

  Efficacy of sending patient to right level of care. Is it better to start early during transport by using the PCM mattress or miss the window of opportunity of 6h due to long transportation and/or long decision making. Usage of questionnaire that collect outcome of hypothermia.

  At 96 hours after admission to study for each patient, During the data collection time of the study.

Other Outcomes (2)

• Feasibility and validation of the HildaNeo method, usage.

  Each case is evaluated immediately after the intervention/procedure but the results of all combined is evaluated after completion of study to avoid bias.

• LDH as indicator for HIE

  From date of sample taken during the study until end of data collection, max 100 month. Each case is evaluated immediately after the intervention/procedure but the results of all combined is evaluated after completion of study to avoid bias.

Study Arms (2)

The NeoHilda Point of care method

ACTIVE COMPARATOR

Evaluating baby including lactate dehydregenase Levels measured in umbilical core blood using the fast point of care method called Neo Hilda

Device: The NeoHilda Point of care method

No Measurement of LDH

SHAM COMPARATOR

Evaluating baby without Lactate dehydrogenase result

Procedure: Traditional evaluation

Interventions

The NeoHilda Point of care method DEVICE

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.

Also known as: Neo Hilda, Calmark Sweden AB

The NeoHilda Point of care method

Traditional evaluation PROCEDURE

Traditional way of evaluation

No Measurement of LDH

Eligibility Criteria

• Age: Up to 36 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All children admitted to the neonatal ward above 32w of age, considered for blood sampling.

You may not qualify if:

• parental consent missing
• Gestational age less than 33 weeks postnatal age or above 36 hours after birth

Sponsors & Collaborators

• Karolinska Institutet: lead
• National Children's Hospital, Vietnam: collaborator
• Calmark Sweden AB: collaborator

Study Sites (1)

Neonatal unit, National hospital of Pedriatrics

Hanoi, Dong Da, 18/879, Vietnam

Location

Related Publications (5)

• Karlsson M, Dung KT, Thi TL, Borgstrom E, Jonstam K, Kasstrom L, Winbladh B. Lactate dehydrogenase as an indicator of severe illness in neonatal intensive care patients: a longitudinal cohort study. Acta Paediatr. 2012 Dec;101(12):1225-31. doi: 10.1111/apa.12014.

  PMID: 22963670 BACKGROUND

• Karlsson M, Wiberg-Itzel E, Chakkarapani E, Blennow M, Winbladh B, Thoresen M. Lactate dehydrogenase predicts hypoxic ischaemic encephalopathy in newborn infants: a preliminary study. Acta Paediatr. 2010 Aug;99(8):1139-44. doi: 10.1111/j.1651-2227.2010.01802.x. Epub 2010 Mar 19.

  PMID: 20236255 BACKGROUND

• Wiberg-Itzel E, Akerud H, Andolf E, Hellstrom-Westas L, Winbladh B, Wennerholm UB. Association between adverse neonatal outcome and lactate concentration in amniotic fluid. Obstet Gynecol. 2011 Jul;118(1):135-142. doi: 10.1097/AOG.0b013e318220c0d4.

  PMID: 21691171 BACKGROUND

• Thoresen M, Liu X, Jary S, Brown E, Sabir H, Stone J, Cowan F, Karlsson M. Lactate dehydrogenase in hypothermia-treated newborn infants with hypoxic-ischaemic encephalopathy. Acta Paediatr. 2012 Oct;101(10):1038-44. doi: 10.1111/j.1651-2227.2012.02778.x. Epub 2012 Jul 27.

  PMID: 22775455 BACKGROUND

• Tran HTT, Tran DM, Le HT, Hellstrom-Westas L, Alfven T, Olson L. Cooling during transportation of newborns with hypoxic ischemic encephalopathy using phase change material mattresses in low-resource settings: a randomized controlled trial in Hanoi, Vietnam. BMC Pediatr. 2024 Aug 8;24(1):509. doi: 10.1186/s12887-024-04987-6.

  PMID: 39118070 DERIVED

MeSH Terms

Conditions

Infections

Study Officials

• Hugo Lagercrantz, Professor

  Karolinska Institutet

  STUDY DIRECTOR

• Khu TK Dung, Prof, Vdir.

  National Hospital of Pediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Investigator, Dr.

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: May 4, 2022
• Study Start: August 1, 2013
• Primary Completion: August 31, 2024
• Study Completion: March 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

VN (1)