Antenatal allopurinol for reduction of birth asphyxia induced brain damage (ALLO-Trial); a randomized double blind placebo controlled multicenter study

<p>Abstract</p> <p>Background</p> <p>Hypoxic-ischaemic encephalopathy is associated with development of cerebral palsy and cognitive disability later in life and is therefore one of the fundamental problems in perinatal medicine. The xanthine-oxidase inhibitor allopurinol reduces the formation of free radicals, thereby limiting the amount of hypoxia-reperfusion damage. In case of suspected intra-uterine hypoxia, both animal and human studies suggest that maternal administration of allopurinol immediately prior to delivery reduces hypoxic-ischaemic encephalopathy.</p> <p>Methods/Design</p> <p>The proposed trial is a randomized double blind placebo controlled multicenter study in pregnant women at term in whom the foetus is suspected of intra-uterine hypoxia.</p> <p>Allopurinol 500 mg IV or placebo will be administered antenatally to the pregnant woman when foetal hypoxia is suspected. Foetal distress is being diagnosed by the clinician as an abnormal or non-reassuring foetal heart rate trace, preferably accompanied by either significant ST-wave abnormalities (as detected by the STAN-monitor) or an abnormal foetal blood scalp sampling (pH < 7.20).</p> <p>Primary outcome measures are the amount of S100B (a marker for brain tissue damage) and the severity of oxidative stress (measured by isoprostane, neuroprostane, non protein bound iron and hypoxanthine), both measured in umbilical cord blood. Secondary outcome measures are neonatal mortality, serious composite neonatal morbidity and long-term neurological outcome. Furthermore pharmacokinetics and pharmacodynamics will be investigated.</p> <p>We expect an inclusion of 220 patients (110 per group) to be feasible in an inclusion period of two years. Given a suspected mean value of S100B of 1.05 ug/L (SD 0.37 ug/L) in the placebo group this trial has a power of 90% (alpha 0.05) to detect a mean value of S100B of 0.89 ug/L (SD 0.37 ug/L) in the 'allopurinol-treated' group (z-test_2-sided). Analysis will be by intention to treat and it allows for one interim analysis.</p> <p>Discussion</p> <p>In this trial we aim to answer the question whether antenatal allopurinol administration reduces hypoxic-ischaemic encephalopathy in neonates exposed to foetal hypoxia.</p> <p>Trial registration number</p> <p>Clinical Trials, protocol registration system: NCT00189007</p

Heart rate measuring device

The invention relates to a heart rate measuring apparatus and a method, adapted for measuring a subject's (6) heart rate and/or heart rate variation. The heart rate measuring apparatus (1) comprises a holder (2) adapted for carrying a portion of a body part of the subject (6) lying on or resting against the holder (2), a motion sensor (4) operatively connected to the holder (2), wherein the holder (2) is adapted for being at least partly moveable in a horizontal direction relative to the ground (7), the motion sensor (4) being adapted for measuring a signal generated by a movement of the subject (6) at least partly in the horizontal direction. In this way, a reliable signal is obtained adapted for measuring the heart rate and/or heart rate variation of a subject while keeping the implementation costs low

Viewpoints of parents and nurses on how to design products to enhance parent–infant bonding at neonatal intensive care units:a qualitative study based on existing designs

\u3cp\u3eAim: To investigate how product design can be used to improve parent–infant bonding in a neonatal intensive care unit. Background: Impaired parent–infant bonding is an inevitable consequence of premature birth, which negatively influences development. Products, systems, or services that support the bonding process might counter these negative influences. Method: The first step was to trace existing products by performing a literature search in PubMed, the university library, and Google. The identified existing designs were then used in semistructured interviews with nurses and parents to get insights into their desires and recommendations for product design to enhance bonding. Interviews contained open questions and a multiple-choice questionnaire based on the literature search. Results: In total, 17 existing design types were used in interviews with 11 parents and 23 nurses. All nurses explicitly stated that practicality was the first criterion designs aimed at enhancing bonding definitely had to meet. All parents indicated that they would like to use a design to enhance bonding if that would contribute to their child’s health and development. For both parents and nurses, the most valuable way to enhance bonding seemed to be products to improve Kangaroo care; however, their specific desires varied substantially. Therefore, seven recurring themes were defined, resulting in nine general recommendations and six opportunities intended to enhance parent–infant bonding. Conclusion: This study provides design recommendations and opportunities based on parents’ and nurses’ expert opinions. Designing to enhance bonding is considered valuable; however, designs should match the stakeholders’ desires and conditions.\u3c/p\u3

Neonatal seizure detection with wearable sensors system

Seizures in neonates, the most common sign of neurological dysfunction, require immediate medical attention. A new system for the detection of neonatal seizures using the wearable sensor is presented. The system including smart vest and system software aims for providing reliable continuous monitoring as well as a comfortable clinical environment for neonatal seizure and giving an alarm when seizure occurs on the basis of Electrocardiogram (ECG) and motion sensing techniques. We present the concept of the neonatal vest that enables ECG measurement by textile and motion measurement by Inertial Measurement Units (IMU). Furthermore, we explore a new software system for receiving, displaying and analyzing data based on android system. An iterative design process in close contact with experts and designers leads to a balanced integration of technology and aesthetics. We demonstrate the design process and the work in progress on the prototype

Unobtrusive monitoring of neonatal brain temperature using a zero-heat-flux sensor matrix

\u3cp\u3eThe temperature of preterm neonates must be maintained within a narrow window to ensure their survival. Continuously measuring their core temperature provides an optimal means of monitoring their thermoregulation and their response to environmental changes. However, existing methods of measuring core temperature can be very obtrusive, such as rectal probes, or inaccurate/lagging, such as skin temperature sensors and spotchecks using tympanic temperature sensors. This study investigates an unobtrusive method of measuring brain temperature continuously using an embedded zero-heat-flux (ZHF) sensor matrix placed under the head of the neonate. The measured temperature profile is used to segment areas of motion and incorrect positioning, where the neonate's head is not above the sensors. We compare our measurements during low motion/stable periods to esophageal temperatures for 12 preterm neonates, measured for an average of 5 h per neonate. The method we propose shows good correlation with the reference temperature for most of the neonates. The unobtrusive embedding of the matrix in the neonate's environment poses no harm or disturbance to the care work-flow, while measuring core temperature. To address the effect of motion on the ZHF measurements in the current embodiment, we recommend a more ergonomic embedding ensuring the sensors are continuously placed under the neonate's head.\u3c/p\u3

Near-continuous non-contact cardiac pulse monitoring in a neonatal intensive care unit in near darkness

\u3cp\u3eCurrently, the cardiac activity of infants in the Neonatal Intensive Care Unit (NICU) is monitored with contact sensors. These techniques can cause injuries and infections, particularly in very premature infants with fragile skin. Recently, remote photoplethysmography (rPPG) showed its potential to measure cardiac activity with a camera without skin contact. The main limitations of this technique are its lack of robustness to subject motion and visible light requirements. The aim of this study is to investigate the feasibility of robust rPPG for NICU patients in near darkness. Video recordings using dedicated infrared illumination were made of 7 infants, age 30-33 weeks, at a NICU in Eindhoven, The Netherlands. The pulse rate can be detected with an average error of 1.5 BPM and 2.1 BPM when measured at the face and upper torso region, respectively. Overall, the correct pulse rate is detected for 87% of the time. A camera-based framework for robust pulse extraction in near darkness of NICU patients was proposed and successfully validated. The pulse rate could be reliably detected from all evaluated skin regions. Recordings with vigorous body movements, involving occlusion of the selected skin region, are still a challenge.\u3c/p\u3