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NCT06915467
The aim of this study is to demonstrate, with a good level of evidence, the efficacy, safety and feasibility of placing an umbilical route through Wharton's jelly, in the context of emergency situations in the delivery room.
NCT06081075
Genomic methods can significantly contribute to all facets of precision medicine, from diagnosis to prevention, therapeutic intervention, and management of acute and chronic illnesses. DNA based methods are already having a considerable impact across healthcare in fields that include: public health, infectious disease monitoring, acute and chronic disease, pharmacogenomics, prenatal testing and diagnosis, and therapeutic development. In this proposal, investigators are focusing on the application of genomic methods in precision medicine - specifically on rapid whole-genome sequencing of parents and children (i.e. a trio) for the identification of diseases that have genetic components. Goals Primary goal: is to provide safe rapid whole genome sequencing to Neonatal Intensive Care Unit/Pediatric Intensive Care Unit patients. Secondary goals: 1) Although several groups globally are implementing rapid sequencing of rare disease, these are predominantly in the research space, with many unanswered questions regarding the best way to implement them into a national healthcare system. Each country and their healthcare systems are unique, and valuable knowledge will be gained by implementing this process within a New Zealand context. As part of this the study will measure the impact on the individuals and families. 2\) to expand the research team's understanding of non-coding disease-causing variants and methylation changes that contribute to severe disease in early life. Primary Aims 1. To incorporate long-read RNA sequencing data into the diagnostic rapid Whole Genome Sequencing pipeline to provide a direct measure of the functional outcome of the variants of clinical concern. 2. To measure the clinical utility of analysing non-coding variants in the diagnosis of critically ill children who do not have pathogenic, likely pathogenic, or variants of unknown significance for mendelian disorders. 3. To identify, in a real-world setting within the New Zealand health-care system, the clinical and economic effects of deploying rapid Whole Genome Sequencing-informed rapid precision medicine for critically ill children.
NCT06880003
In this study, cord blood preptin levels in infants with high or low birth weight will be compared to those in infants with normal birth weight. Our aim is to determine whether there is a relationship between birth weight and preptin levels. Additionally, we plan to compare the cord blood preptin levels of infants of diabetic mothers with those of normal birth weight infants.
NCT04070066
Abstract Background: Exchange transfusion is a highly complex procedure that requires high levels of expertise. Paediatricians trainees do not have adequate training because opportunities to perform this procedure in practice are scarce. This protocol seeks to compare two educational interventions for exchange transfusions that allow the students to develop competencies to perform the technique in an appropriate and safe way. Methods/design: A randomized parallel single-blind clinical trial with allocation by simple randomization to the educational intervention (simulation or a digital didactic environment). Students from the paediatric specialization who volunteer to participate will be included. A practical evaluation of the procedure will be performed through a simulated scenario using a standardized clinical case. The main outcome is defined as the result of evaluation using the Objective Structured Clinical Examination; superior performance will be defined when the percentage is greater than or equal to 85%, and nonsuperior performance will be defined when the result is less than 84%. The chi-square independence test or the Fisher exact test will be used to evaluate the effect of the interventions. Multivariate analysis will be performed using a non-conditional logistic regression model. Stata 14 ® software will be used. Discussion: Exchange transfusion is a procedure that requires expertise to achieve adequate outcomes. The inclusion of new educational strategies, such as simulation and digital didactic environments, is seen as a training option that can improve performance in clinical skills, reduce adverse events and increase the level of trust.
NCT06254651
Positive pressure ventilation (PPV) is the most important intervention in neonatal resuscitation. During PPV, it is important to hold the face-mask with care, as applying excessive pressure could cause injury to the infant, while insufficient pressure could be a contributor of mask leak and reduced effective ventilation. Application of positive pressure to face structures may trigger a vagally mediated reflex via the trigeminal nerve that innervates the skin of the face leading to apnoea and a decrease in heart rate (TCR, trigeminal-cardiac reflex). The force exerted by providers during neonatal ventilation to improve mask seal might result in pressure lesions and the elicitation of the trigeminal-cardiac reflex. The height of the resuscitation could influence the forces applied to the face and the quality of the procedure. Information about the applied forces in relation to the height of the resuscitation table is unknown.
NCT06170892
The kangaroo position, which is part of the Kangaroo Method strategy, is widely used in the Neonatal Intensive Care Unit and Neonatal Intermediate Care Units and aims to promote emotional bonding, cardiorespiratory, physiological and body temperature stability, in However, there is still little scientific evidence when it comes to newborns undergoing oxygen therapy. Identify, quantify and analyze the influence of the kangaroo position on the vital signs and respiratory comfort of preterm newborns using supplemental oxygen. To collect data, a physiotherapeutic assessment form suitable for clinical analysis was used. The newborns were placed in the kangaroo position in a single session, and the variables were identified before, during and after the application of the technique.
NCT05728307
The goal of this study is to measure the clinical impact and cost-effectiveness of a wireless vital signs monitor, neoGuard, for hospitalized newborns at a tertiary healthcare facility in Kenya. The main questions it aims to answer are: 1. Does the neoGuard vital signs monitor detect meaningful vital sign changes in hospitalized newborns? 2. Does the neoGuard vital signs monitor generate valid signals to trigger a timely response from nurses? 3. Is the neoGuard vital signs monitor associated with improved patient outcomes and lower mortality? 4. What is the cost-effectiveness of the neoGuard vital signs monitor in comparison to the standard-of-care monitoring system? Participants will be enrolled within the first 24 hours of admission and monitored for a period of 7 consecutive days or until they are discharged (whichever comes sooner). The study will consist of an intervention group and a comparison group. Researchers will compare nurses' response time to patients in distress, newborn complication rates and treatment outcomes between the two groups.
NCT05851222
This observational retrospective study aims to learn about the incidence of acute kidney (AKI) injury in newborns in infants exposed to nephrotoxic drugs with a big data approach. The main question it aims to answer are: * Develop a model that can predict the occurrence of AKI in infants admitted to the NICU; * Identify the drug or combination of drugs associated with an increased risk of AKI. The group of infants exposed to drugs will be defined based on exposure for at least 1-day tone one or more therapies commonly used in the NICU. Once the AKI event has occurred, the observation of the trend of daily creatinine and diuresis values will be continued for the period covered by the study.
NCT04606589
The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns. This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.
NCT04060381
Knowledge on the changes in myocardial function in the last weeks before birth and during the first year of life is limited. Through fetal and post-natal echocardiography we intend to describe these changes using myocardial tissue recognition techniques (Speckle tracking echocardiography and Tissue Doppler echocardiography) in healthy neonates, born to term of healthy women after uncomplicated pregnancies. We will compare the findings in this cohort to a cohort of neonates born to term of women with severe pre-pregnancy obesity. Sick neonates in intensive care units with various cardiac and non-cardiac conditions are often exposed to treatment that may affect both their cardiac function and important echo-variables per se. Using echocardiography, we will examine these changes in neonates treated with blood transfusion, catecholamines and in those treated with Ibuprofen due to a haemodynamic significant arterial duct.
NCT04563065
Historically and traditionally, the recommendations related to physical exercise during pregnancy have been based more on moral or cultural issues than on scientific evidence. During some phases of history, pregnancy has meant a period of seclusion for women (not only physical). One of the adverse consequences has been the common recommendation of rest as a general rule for pregnant women. Scientific evidence from recent years has achieved a better understanding of the process of pregnancy and childbirth as well as maternal and fetal responses to exercise. Currently, both from a scientific and clinical/obstetric point of view, there is no doubt about the benefits of an active pregnancy for entire body of pregnant woman, and even her child. In fact, risks of a sedentary lifestyle are applicable to the pregnancy situation, even more with important associated complications during pregnancy and postpartum period. Unfortunately, the impact of COVID-19 has caused an unprecedented global crisis, in this sense the necessary measures taken by the different administrations, especially in terms of confinement causes (from now on) a large number of complications affecting different populations. In summary a complex situation without established prevention strategies exists. The pregnant population is, due to the nature of the gestation and delivery process, one of the population groups with the highest risk of adverse outcomes and associated complications and whose consequences include the mother, fetus, newborn and even children. According to an important body of scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining factor for the future human being to evolve regardless of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and observable postnatal pathologies in infants. In addition, current publications report the large number and variety of alterations that the COVID-19 situation causes in pregnant women and that includes the entire female organism. This complex situation does not only affect aspects of a physical or physiological nature, but also psychic and emotional factors. In summary, a new state of confinement or similar situations in the near future (impossibility of groupings, distance between people), avoid during the daily life of pregnant women one of the important and recent recommendations made by the international scientific community: a pregnancy physically active. This is especially relevant, due to the dangerous association between complications of a psychological or emotional nature during pregnancy with pre, peri and postnatal disorders (low birth weights, perinatal complications, altered and prolonged deliveries, etc.), which affect not only to the mother and can determine the health of the future human being. According to the scientific literature and based on an epigenetic effect, the intrauterine environment can be a determining aspect in the health of the future human being and the prevention of complications and pathologies (cardiovascular, metabolic, psychic, emotional). This is demonstrated by numerous and recent scientific evidences that confirm the unfortunate association between an adverse intrauterine environment (due to various factors) and different pathologies during and after pregnancy. It is evident the change that COVID-19 and its effects will generate in the lifestyle of the pregnant population and the increased probability of suffering associated pathologies in the next 24-36 months. No preventive actions have yet been planned in Spain and its public hospitals against the impact of COVID-19 on the quality of life of pregnant women. It is urgent to design and perform an adequate strategy of intervention for its possible prevention. From the scientific point of view, the recommendations are clear and concrete, an aerobic exercise program, designed and supervised by professionals from the Sciences of Physical Activity and Sports, is the best option for pregnant women. In this sense, in the last 30 years, physical exercise has proven to have many benefits for pregnant women, without causing risks or adverse effects on maternal-fetal well-being. This is confirmed by an important body of scientific literature on gestational physical exercise and its effects on pregnancy outcomes.
NCT02300285
Our aim is to determine the feasibility of using continuous glucose monitors (CGMs) in infants with low blood glucose to improve how we care for these infants. To do this we plan on monitoring blood glucose levels with CGMs (instead of only with intermittent bloodsampling) in late-preterm and term infants admitted to the NICU who have had hypoglycemia. To see if using CGMs helps us prevent low blood glucose levels and allows us to find a diagnosis and treat sooner, we will randomize patients into one of two groups: a "CGM group" where the CGM information is made available to the NICU team and a "Standard of Care" group where the CGM information will only be available to the research team. However, if infants in the "Standard of Care" group are noted to have three unrecognized severe low blood glucose levels then the research team will inform the NICU team that this has occurred.
NCT04184544
The Umeed-e-Nau (UeN) initiative aims to support the introduction, scale up, and further piloting of high quality and high impact interventions to improve Maternal, Newborn And Child Health (MNCH)in Pakistan by harnessing the potential of both public and private sectors, coupled with introduction of women and girls empowerment interventions. UeN has two major components: 1) Introducing proven effective MNCH interventions at scale in 8 rural districts of Pakistan, and 2) Generating evidence on innovative approaches to improve MNCH while included in public health programs in Pakistan. There are six trials that are being conducted to address different evidences gaps to improve maternal, newborn and child health in Pakistan. The protocols of the trials will be registered separately.
NCT04785183
Preterm infants are at risk of free radical mediated diseases from oxidative stress (OS) injury. Melatonin (MEL) is a powerful antioxidant and scavenger of free radicals. In preterm neonates, melatonin deficiency has been reported. Several studies tested the efficacy of melatonin to counteract oxidative damage in diseases of newborns such as chronic lung disease, perinatal brain injury, necrotizing enterocolitis, retinopathy of prematurity and sepsis, giving promising results. In these studies, the dosages of melatonin varied over a wide range. The present study was designed to test the hypothesis that oral administration of melatonin reduced OS and consequentially, the occurrence of intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP) and bronchopulmonary dysplasia (BPD) in preterm newborns.
NCT04760509
Neural tube defects (NTD), which is the most common anomaly of the central nervous system, which can be diagnosed during antenatal period, brings many problems both in the neonatal period and in advanced ages. Open neural tube defects, in particular, progress with sensory-motor deficits due to the risk of infection and neural tissue loss from birth, and should be followed closely from the neonatal period. Newborns born with a neural tube defect should be operated within the first 72 hours postnatal and the defect should be closed. In this hospital, newborns with NTD are monitored in our neonatal surgery intensive care unit before and after surgery. Neonatal specialists, neurosurgeons and other specialists when there is an additional anomaly evaluate the baby as multidisciplinary. In this project, the short-term follow-up data of babies with NTD who have been followed up in this neonatal surgery intensive care unit for the last fifteen years will be evaluated retrospectively.
NCT01346813
Sick or premature neonates are exposed to frequent painful and stressful procedures during their stay in neonatal intensive care units. Although neonates do feel pain and may have long term effects induced by painful experiences, prevention and treatment of neonatal pain is far from optimal in many units. An epidemiological study (EPIPPAIN) conducted in neonatal and pediatric intensive care units in France in 2005 showed that painful procedures were extremely frequent and that analgesics treatments varied a lot among units. Since many guidelines have been issued by international scientific societies to manage neonatal pain, one may expect that the prevention and treatment of neonatal pain has improved over the last 6 years. Although awake endotracheal intubations are extremely difficult or impossible in older children or adults, such intubations are still frequently performed without sedation/analgesia in neonates. Recent studies have shown that premedications facilitate intubation conditions and greatly improve neonates tolerance of the procedure. Studies aimed at assessing the risks and benefits of different sedations/analgesia strategies are urgently needed in neonates. We also need a tool to assess at the same time the technical conditions of intubations and the tolerance of the neonate to the procedure so that data from different studies can be compared. The objectives of the present study are: 1. To describe the incidence of painful and stressful procedures performed in the neonate in intensive care units as well as in neonates transported by the medical emergency system (SMUR) of the Ile-de-France region 6 years after the first EPPIPAIN study conducted in the same region and same type of population in order to assess the evolution of practices. The description of painful and stressful procedures will be completed with a real-time around-the-clock assessment of the pain induced by procedures using a validated behavioral pain scale. 2. To link this study with The Epipage study 2 in order to look for associations between the number of painful and stressful procedures and/or analgesic treatments of the neonatal period and the neurological outcome of children that will be followed in the Epipage cohort. The Epipage study is a separate study that will follow for 13 years a cohort of premature neonates recruited in 2011. 3. To describe the incidence of painful or stressful procedures and analgesic treatments in neonates transported by the pediatric emergency system (SMUR) of the Ile-de-France region in France. 4. To obtain initial validity of a tool permitting to assess intubations in neonates. An observational detailed description of endotracheal intubations conditions will be conducted in neonates transported and intubated by SMUR and in neonates intubated in intensive care units 5. To describe continuous sedation and analgesia practices in ventilated neonates in intensive care units. For these neonates, data from medical records will be recovered up to 2 months of admission in intensive care units 6. To describe the frequency of heel sticks for glycemia measurement and blood gazes practices among centers. Relate heel stick practices to the normality or abnormality of glycemia results