Operating MiraCradle® - Neonate Cooler

Huge amount of research has been done across the world on therapeutic hypothermia for cooling babies suffering from HIE. In this section, we bring you a compilation of some of the best research papers on this subject.

1
Phase Changing Material: An Alternative Method for Cooling Babies with Hypoxic Ischaemic Encephalopathy

Abstract:

Therapeutic hypothermia for hypoxic ischaemic encephalopathy (HIE) has been proved effective. Standard equipment is expensive, while ice packs used in low resource settings are labour intensive and associated with wider temperature fluctuations. Objectives: To assess the feasibility of using phase changing material (PCM) as an alternative method for providing therapeutic hypothermia. Methods: We retrospectively analysed 41 babies with HIE who had been cooled with PCM (OM 32™ or HS 29™) to a target rectal temperature of 33-34°C. Rectal temperature was continuously monitored and recorded every hour. If the rectal temperature was >33.8°C, cool gel packs were applied, and if the temperature was 33.2°C, the baby was covered with sheets and the warmer output turned on till the temperature stabilized at 33.5°C. The unit's standard protocol for cooling was followed for monitoring and treatment.

The outcome measures were stability and fluctuation of the rectal temperature and the need for interventions to maintain the target temperature. Results: The mean (±SD) temperature during the cooling phase was 33.45 ± 0.26°C. Throughout the cooling phase, the target temperature range was maintained in 96.2% of the time. There was no temperature reading 32°C. With HS 29, ice packs were not used in any baby, and the warmer was used for a median of 7 h (interquartile range 1.5-14). Conclusions: PCM provides a low cost and effective method to maintain therapeutic hypothermia. However, careful monitoring is required during induction and the rewarming phase to avoid hypothermia outside the therapeutic range.

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2
Cool competence. The nursing challenges of therapeutic hypothermia

Author(s): Karina Vandertak
Abstract

Therapeutic hypothermia is a new and growing intervention for the treatment of birth asphyxia. Hypothermia has always been something that the neonatal nurse vigorously works to avoid in her patients. Now, nurses are expected to deliberately induce hypothermia. This paper explores the nursing issues involved in caring for these babies. It considers the challenge of gaining and maintaining competence, assessing the baby and supporting the parents

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3
Effect of Treatment of Subclinical Neonatal Seizures Detected With aEEG: Randomized, Controlled Trial

Author(s):
  • 1. Linda G. M. van Rooij, MD,
  • 2. Mona C. Toet, MD, PhD,
  • 3. Alexander C. van Huffelen, MD, PhD,
  • 4. Floris Groenendaal, MD, PhD,
  • 5. Wijnand Laan, PhD,
  • 6. Alexandra Zecic, MD,
  • 7. Timo de Haan, MD, PhD,
  • 8. Irma L. M. van Straaten, MD, PhD,
  • 9. Sabine Vrancken, MD,
  • 10. Gerda van Wezel, MD, PhD,
  • 11. Jaqueline van der Sluijs, MD,
  • 12. Henk ter Horst, MD,
  • 13. Danilo Gavilanes, MD, PhD,
  • 14. Sabrina Laroche, MD,
  • 15. Gunnar Naulaers, MD, PhD,
  • 16. Linda S. de Vries, MD, PhD
Abstract:

OBJECTIVES: The goals were to investigate how many subclinical seizures in full-term neonates with hypoxic-ischemic encephalopathy (HIE) would be missed without continuous amplitude-integrated electroencephalography (aEEG) and whether immediate treatment of both clinical and subclinical seizures would result in a reduction in the total duration of seizures and a decrease in brain injury, as seen on MRI scans.

METHODS: In this multicenter, randomized, controlled trial, term infants with moderate to severe HIE and subclinical seizures were assigned randomly to either treatment of both clinical seizures and subclinical seizure patterns (group A) or blinding of the aEEG registration and treatment of clinical seizures only (group B). All recordings were reviewed with respect to the duration of seizure patterns and the use of antiepileptic drugs (AEDs). MRI scans were scored for the severity of brain injury.

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4
Amplitude-integrated EEG Classification and Interpretation in Preterm and Term Infants

Author(s): Hellström-Westas, et al.

OBJECTIVES

After completing this article, readers should be able to:
1. Understand the amplitude-integrated electroencephalography (aEEG) method and its utility and limitations.
2. Classify and interpret typical aEEG background patterns.
3. Identify epileptic seizure activity in the AEEG.
4. Describe features in the aEEG recording that are associated with prognosis.

INTRODUCTION

Amplitude-integrated electroencephalography (aEEG) is a method for continuous monitoring of brain function that is used increasingly in neonatal intensive care units (NICUs). The method is based on filtered and compressed EEG that enables evaluation of long-term changes and trends in electrocortical background activity by relatively simple pattern recognition. The cerebral function monitor (CFM) was created by Prior and Maynard in the 1960s for use in adult intensive care. Prior and Maynard aimed for a brain monitoring system that had the following features: simplicity, reasonable cost, reliability, direct information about neuronal function, noninvasiveness and wide applicability, quantification and output, automatic operation, and flexibility. (1) The method was applied to newborns in the late 1970s and early 1980s. (2)(3)(4) The original CFM concept has been developed, and several new machines are now available, all including the aEEG trend recording with simultaneous display of the raw EEG. We and others have chosen to call the method aEEG to distinguish it from a special monitor. Published studies on neonatal aEEG include both clinical and experimental investigations. (5) The finding that the aEEG is suitable for very early prediction of outcome after perinatal asphyxia has resulted in more widespread use of the method, not least since abnormal aEEG readings were an inclusion criterion in one of the recently published hypothermia studies. (6)

For new users of aEEG, the potential of this method is usually striking when clinical aEEG monitoring reveals abnormal brain activity that would otherwise pass unrecognized, such as subclinical seizure activity or transient...

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5
Amplitude-Integrated EEG Is Useful in Predicting Neurodevelopmental Outcome in Full-Term Infants with Hypoxic-Ischemic Encephalopathy: A Meta-Analysis

Author(s): R. Edwin Spitzmiller, DOTonya Phillips, MD, Jareen Meinzen-Derr, PhD, Steven B. Hoath, MD
Abstract

Hypoxic ischemic encephalopathy is a common cause of neurological complications resulting in chronic handicapping conditions, such as cerebral palsy. Amplitude-integrated electroencephalography (EEG) has been used in many European countries for more than a decade in the evaluation of infants with hypoxic ischemic encephalopathy but has not been widely used in the United States. The objective of this study was to evaluate the evidence supporting use of amplitude-integrated EEG as a quantitative predictor of neurodevelopmental outcome in full-term infants with hypoxic ischemic encephalopathy. To assess efficacy, the authors performed a meta-analysis of the literature evaluating the use of the amplitude-integrated EEG or cerebral function monitor in full-term infants with hypoxic ischemic encephalopathy and their neurodevelopmental outcome.

A total of 8 studies were eligible for the primary meta-analysis. There was an overall sensitivity of 91% (95% CI 87-95) and a negative likelihood ratio of 0.09 (95% CI .06-.15) for amplitude-integrated EEG tracings to accurately predict poor outcome. Amplitude-integrated EEG is a valuable bedside tool for predicting long-term neurodevelopmental outcome in term infants with hypoxic ischemic encephalopathy. This information is useful in structuring communication and care plans for physicians and parents. Early assessment techniques such as amplitude-integrated EEG provide objective means for determining inclusion in clinical studies evaluating therapies for hypoxic ischemic encephalopathy and for predicting which patients are most likely to respond to treatment.

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6
Hypothermia after perinatal asphyxia: selection for treatment and cooling protocol.

Author(s): Thoresen M
Abstract

Three large randomized controlled trials have demonstrated benefits from 3 days of cooling to 33-34°C after perinatal asphyxia. No serious adverse effects were documented. The trials excluded many infants for hypothermia (HT) therapy, including those of age >6 hours and those with prematurity of 36 weeks gestation, abnormal coagulation, persistent pulmonary hypertension, and congenital abnormalities. This article considers whether the foregoing trial exclusion criteria are feasible given current knowledge and evidence. HT affects the validity of some outcome predictors (eg, clinical examination, amplitude-integrated electroencephalography), but not of magnetic resonance imaging. HT is a time-critical emergency treatment after perinatal asphyxia that requires optimal collaboration among local hospitals, transport teams, and cooling centers.

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7
Hypoxic-ischemic encephalopathy: challenges in outcome and prediction.

Author(s): Perlman M, Shah PS.
Abstract

The outcomes of hypoxic-ischemic encephalopathy vary between death and intact survival. The spectrum of long-term morbidity in survivors ranges from mild motor and cognitive deficits to cerebral palsy and severe cognitive deficits. Our literature review reinforces the notion that the spectrum of hypoxic-ischemic encephalopathy outcomes represents a continuum, which has important implications for the prediction of outcome and the indications for intervention. We summarize predictive criteria at 3 time points: the first 6 hours of life, 6-72 hours of life, and at hospital discharge. In this era of neuroprotection, predictive models that aid therapeutic decision making, including the withdrawal of support, need to be revised.

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8
Clinical management of the baby with hypoxic ischaemic encephalopathy.

Author(s): Denis Azzopardi
ABSTRACT

The results of randomized clinical trials indicate that the optimal management for infants with hypoxic ischaemic encephalopathy is therapeutic hypothermia combined with high quality standard neonatal intensive care. In addition to therapeutic hypothermia clinical management of the infant with hypoxic ischaemic encephalopathy should include the management of multiorgan dysfunction, obtaining and documenting detailed clinical information and performing appropriate investigations and assessment to confirm the diagnosis and to help direct care, and providing counseling and support to the family. This article is a summary of the in hospital clinical management of infants with hypoxic ischaemic encephalopathy.

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9
Experimental treatments for hypoxic ischaemic encephalopathy.

Author(s): Dorottya Kelen, Nicola J Robertson
ABSTRACT

Hypoxic ischemic encephalopathy continues to be a significant cause of death and disability worldwide. In the last 1-2 years, therapeutic hypothermia has entered clinical practice in industrialized countries and neuroprotection of the newborn has become a reality. The benefits and safety of cooling under intensive care settings have been shown consistently in trials; therapeutic hypothermia reduces death and neurological impairment at 18 months with a number needed to treat of approximately nine. Unfortunately, around half the infants who receive therapeutic hypothermia still have abnormal outcomes.

Recent experimental data suggest that the addition of another agent to cooling may enhance overall protection either additively or synergistically. This review discusses agents such as inhaled xenon, N-acetylcysteine, melatonin, erythropoietin and anticonvulsants. The role of biomarkers to speed up clinical translation is discussed, in particular, the use of the cerebral magnetic resonance spectroscopy lactate/N-acetyl

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10
Induced Hypothermia for Neonates With Hypoxic-Ischemic Encephalopathy

Author(s): Melissa Long and Debra H. Brandon
Abstract:

Hypoxic-ischemic encephalopathy causes significant morbidity and mortality in neonates. Preventing the secondary reperfusion injury that occurs following a hypoxic-ischemic event is paramount to ensuring the best possible neurologic outcome for the neonate. Induced hypothermia is currently being studied in various institutions as a means of neuroprotection for neonates at risk of severe brain injury following a hypoxic-ischemic event. This article highlights the pathophysiology of hypoxic-ischemic encephalopathy and the rationale behind the effectiveness of induced hypothermia.

Nursing care and management of neonates being treated with induced hypothermia are discussed. JOGNN, 36, 293-298; 2007. DOI: 10.1111/J.1552-6909.2007.00150.x

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11
Therapeutic hypothermia for neonatal hypoxic ischemic encephalopathy

Author(s): Aniko Roka, Denis Azzopardi
Abstract

There is now a strong evidence base supporting therapeutic hypothermia for infants with moderate or severe neonatal hypoxic ischaemic encephalopathy. Experimental and clinical data indicate that induced hypothermia reduces cerebral hypoxic ischaemic injury and randomized clinical trials in newborns with hypoxic ischaemic encephalopathy confirm improved neurological outcomes and survival at 18 months of age with therapeutic hypothermia. Studies are on-going to confirm whether these benefits are maintained in later childhood.

Efforts are now focused on optimal implementation of therapeutic hypothermia in clinical practice: training in the assessment of severity of encephalopathy; initiation and maintenance of hypothermia before admission to a cooling facility; care of the infant during cooling; and appropriate investigation and follow-up are crucial for optimizing neurological outcomes. The establishment of registries of infants with hypoxic ischaemic encephalopathy and audit are important for guiding clinical practice.

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12
Hypothermia for the treatment of infants with hypoxic-ischemic encephalopathy.

Author(s): Pfister RH, Soll RF
Abstract

Neonatal encephalopathy affects 2 to 5 of every 1000 live births and represents a major cause of mortality and long-term morbidity in affected infants. Hypoxic ischemic encephalopathy (HIE) is the major cause of encephalopathy in the neonatal period. Until recently, management of a newborn with encephalopathy has consisted largely of supportive care to restore and maintain cerebral perfusion, provide adequate gas exchange and treat seizure activity. Recent randomized controlled trials have shown that mild therapeutic hypothermia (cooling) initiated within 6th of birth reduces death and disability in these infants. Cooling can be accomplished through whole-body cooling or selective head cooling. Meta-analysis of these trials suggests that for every six or seven infants with moderate to severe HIE who are treated with mild hypothermia, there will be one fewer infant who dies or has significant neurodevelopmental disability.

In response to this evidence, major policy makers and guideline developers have recommended that cooling therapy be offered to infants with moderate to severe HIE. The dissemination of this new therapy will require improved identification of infants with HIE and regional commitment to allow these infants to be cared for in a timely manner.

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13
Technical Aspects of Starting a Neonatal Cooling Program

Author(s): John D.E. Barks, MD
Abstract

Clinicians who are convinced by the available evidence that cooling is a safe and effective treatment of hypoxic-ischemic encephalopathy in the term or near-term infant are now faced with a series of decisions around implementation of therapeutic hypothermia in their neonatal ICU or region. There is currently uncertainty about the efficacy of cooling or at least the magnitude of the effect, and precise estimates of the benefit of cooling must await the publication of the results of the several pending trials. This article assumes that clinicians are sufficiently convinced by the available evidence of safety and efficacy to proceed to the implementation step and offers guidelines for starting a neonatal cooling program.

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14
Management of Birth Asphyxia in Home Deliveries in Rural Gadchiroli: The Effect of Two Types of Birth Attendants and of Resuscitating with Mouth-to-Mouth, Tube-Mask or Bag–Mask

Author(s): Abhay T Bang MD, MPH, Rani A Bang MD, MPH, Sanjay B Baitule DHMS, Hanimi M Reddy PhD and Mahesh D Deshmukh MSc
Abstract

OBJECTIVES: To evaluate the effect of home-based neonatal care on birth asphyxia and to compare the effectiveness of two types of workers and three methods of resuscitation in home delivery.

STUDY DESIGN: In a field trial of home-based neonatal care in rural Gadchiroli, India, birth asphyxia in home deliveries was managed differently during different phases. Trained traditional birth attendants (TBA) used mouth-to-mouth resuscitation in the baseline years (1993 to 1995). Additional village health workers (VHWs) only observed in 1995 to 1996. In the intervention years (1996 to 2003), they used tube-mask (1996 to 1999) and bag-mask (1999 to 2003). The incidence, case fatality (CF) and asphyxia-specific mortality rate (ASMR) during different phases were compared.

RESULTS: During the intervention years, 5033 home deliveries occurred. VHWs were present during 84% home deliveries. The incidence of mild birth asphyxia decreased by 60%, from 14% in the observation year (1995 to 1996) to 6% in the intervention years (p 0.0001). The incidence of severe asphyxia did not change significantly, but the CF in neonates with severe asphyxia decreased by 47.5%, from 39 to 20% (p 0.07) and ASMR by 65%, from 11 to 4% (p 0.02). Mouth-to-mouth resuscitation reduced the ASMR by 12%, tube–mask further reduced the CF by 27% and the ASMR by 67%. The bag–mask showed an additional decrease in CF of 39% and in the fresh stillbirth rate of 33% in comparison to tube–mask (not significant). The cost of bag and mask was $13 per averted death. Oxytocic injection administered by unqualified doctors showed an odds ratio of three for the occurrence of severe asphyxia or fresh stillbirth.

CONCLUSIONS: Home-based interventions delivered by a team of TBA and a semiskilled VHW reduced the asphyxia-related neonatal mortality by 65% compared to only TBA. The bag–mask appears to be superior to tube–mask or mouth-to-mouth resuscitation, with an estimated equipment cost of $13 per death averted.

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  • Included in the WHO Compendium of Innovative Health Technologies for Low Resource Setting
  • Winner at the Innovators’ Competition for DST- Lockheed Martin India innovation Growth Programme 2015
  • Developed in collaboration with Christian Medical College, Vellore
  • Designed under NID’s Design Clinic Scheme for MSME’s
  • Winner of CII Industrial Innovation Award – 2014
  • Winner of India Innovates: 2020 award by ASSOCHAM
  • Winner of Plasticon Awards 2015
  • Winner of Kirloskar Technology Awards 2015


  • Winner of Healthcare Excellence Award at Indo- Global Healthcare Summit & Expo’ 14


  • First of its kind device in the world


  • MiraCradle® Neonate Cooler is helping save thousands of babies across the globe


  • Product design: Satish Gokhale, Design Directions Pvt. Ltd.

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MiraCradle® Neonate Cooler being used to treat babies

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