View clinical trials related to Asphyxia Neonatorum.
Filter by:The goal of this feasibility pilot clinical trial is to learn if sildenafil citrate 50mg orally, up to three times during labor, can be appropriately administered, with limited clinical side effects, to laboring mothers to determine feasibility across a spectrum of available healthcare resources. The main questions it aims to answer are: - What are the fetal heart rate monitoring practices in a low-resource setting? - What are the indications for operative delivery in a low-resource? - What is the rate of relevant primary and secondary outcomes to possibly target in a large RCT of intrapartum sildenafil? - What is the limited effect size of sildenafil citrate on maternal and neonatal outcomes in a low-resource setting? Researchers will compare the administration of sildenafil citrate 50 mg orally to a placebo (a look-alike substance that contains no drug) to see if procedures are feasible, the drug is tolerated, the target outcomes are achievable, and effect size is as expected. Participants will: - Take Sildenafil 50 mg/placebo every eight hours or a placebo every eight hours for up to 24 hours during labor - Have the (mothers & babies) medical charts reviewed for outcomes, including fetal distress, operative delivery, maternal side effects, neonatal bag & mask ventilation, Apgar scores, and seizures. - Have a neonatal neurological assessment prior to discharge - Have phone call assessments for re-hospitalization or mortality 7 days post-delivery - Receive child development assessments at 1 year, 2 years and 3 years of age by the Ages and Stages Questionnaire administered via a telephone call The results of this feasibility pilot trial will be used to inform the design and conduct of a large pragmatic randomized controlled trial to determine if sildenafil citrate, compared to placebo, will decrease fetal distress and perinatal asphyxia.
The purpose of this study is to identify and analyze suboptimal perinatal (obstetric-pediatric) care in the occurrence and management of severe perinatal asphyxia or death of the newborn at or near term. Perinatal asphyxia is a serious and often unexpected pathology, requiring urgent multidisciplinary care (obstetric - pediatric - intensive care, etc.) with a high level of technical expertise and care coordination. Because of its rarity and complexity, it may be subject to suboptimal care. The aim of this study is to provide feedback within the center itself, coupled in 1/3 of cases with a confidential investigation into the search for and understanding of suboptimal care. Primary endpoint: Frequency of optimal or non-optimal maternal and neonatal management of hypoxic-ischemic encephalopathy (AIE) or neonatal death related to severe perinatal asphyxia.
The goal of this observational study is to explore the impact of pregnancy depression on infant feeding, and to explore the two-way relationship between postpartum depression and infant feeding. Participants will be asked to finish questionnaires four times (24 weeks of pregnancy to before delivery, 2 month postpartum, 4 month postpartum, 6 month postpartum).
Around the time of birth, some babies experience a condition called asphyxia, which means that their brain and other organs do not receive enough blood and/or oxygen to work properly. This life-threatening condition accounts for nearly 1 out of 4 deaths of all babies around the world, and often leads to severe brain damage, cerebral palsy, epilepsy, and trouble with learning and functioning in everyday life. At this time, no treatment is available to repair the brain damage caused by asphyxia. Excitingly, a drug called sildenafil (Viagra®) is already given safely to babies who suffer from increased blood pressure in their lungs' vessels. Recent studies using a laboratory model of asphyxia at birth suggest that sildenafil may also repair the brain damage caused by asphyxia. Similarly, recent small studies have shown that it is both feasible and safe to give sildenafil to human babies, who suffered from asphyxia at birth. These studies also highlight the first promising signs that sildenafil may improve how the brains of these babies work, which is consistent with the abovementioned laboratory studies. On the basis of these previous researches, the investigators predict that sildenafil can repair the damage to a baby's brain. The investigators will test whether sildenafil can be safely given to a large group of human babies who suffer from asphyxia at birth, and will confirm whether sildenafil improves or not how their brains and hearts/lungs work. This project will enable to determine whether sildenafil is a promising treatment for repairing brain damage in babies who suffer from asphyxia at birth. This project may also provide new solutions for these babies to improve their future life.
Perinatal depression and anxiety (PDA) are the leading causes of maternal mortality in developed countries. Women with a history of depression have a 20 fold higher risk of PDA at subsequent pregnancies. The adverse outcomes extend beyond maternal well-being to long-term deficits in children and families. The gut-brain axis is a newly recognized key player in mental health disorders. Specifically, the microbial composition of the gut along with their metabolites are directly involved in disease onset and course. Recent clinical studies have identified diet as the most powerful environmental factor in manipulating gut microbiome. Given vulnerability and resistance of pregnant women to pharmacotherapy, particularly in those with a predisposition to mood disorders, as well as pregnant women's high motivation and commitment to improving gestational diet, a dietary/supplemental intervention to 'optimize' gut microbiome, is a favored approach in disease management. The study investigators aim to exploit microbial responsiveness to diet together with this maternal motivation, to alter the risk and severity of a universal public health concern that has dire and long-term consequences for new moms and their children. The investigators of this trial, will first study the challenges in pursuing a study aimed at changing the microbiome of pregnant women with a history of mood disorders. Pregnant women in their second trimester will be recruited. Each will be assigned or randomized to one of four groups that will use a combination of diet, supplementation with probiotics, fish oil or no intervention. Each participant will meet with the study team virtually every 3 months until 1 year after delivery. At each study visit participants will be required to complete some questionnaires about their food intake, mood, and other health related measures and will provide a stool sample using the stool collection kits provided. The findings from this study will help strategize for a larger study that will allow for comparison of the effects of diet, and/or supplementation with Omega-3 Fatty Acids (O3FA) and probiotics on the microbiome and the onset and severity of PDA.
The goal of this randomised control trial is to establish the safety and efficacy of whole-body hypothermia for babies with mild hypoxic ischaemic encephalopathy, inform national and international guidelines, and establish uniform practice across the NHS. The main questions it aims to answer are: 1. Does whole-body cooling (33.5+0.5°C) initiated within six hours of birth and continued for 72 hours, improve cognitive development at 24 (±2) months of age after mild neonatal encephalopathy compared with normothermia (37+0.5°C)? 2. Does a prospective trial-based economic evaluation support the provision of cooling therapy for mild encephalopathy in the NHS on cost-effectiveness grounds? Participants will have the following interventions: - Randomisation into one of the following groups - Whole body hypothermia group - Targeted normothermia group - Bayley Scales of Infant and Toddler Development 4th Edition (Bayley-IV) examination at 24 (±2) months of age. Researchers will compare the mean Cognitive Composite Scale score from the Bayley IV examination between the two groups.
The goal of this pilot feasibility/acceptability study is to evaluate the effectiveness of a telehealth approach to increase access to services and reduce depression/anxiety symptoms and risk of substance use in a population of women with perinatal depression/anxiety and elevated substance use risk. The main questions it aims to answer are: - Assess the acceptability and feasibility of a telehealth approach to deliver an 8-week evidence-based group intervention to women with perinatal depression/anxiety and mild to moderate substance use risk. - Obtain preliminary data on treatment response to a telehealth 8-week evidence-based group intervention. Participants will participate in an 8-week evidence-based group intervention and complete the study questionnaire including depression severity, treatment adherence, and substance use risk which will be evaluated at baseline, post-intervention, and 2-month follow-up.
Background: The gestational diabetes mellitus and perinatal depression are both global public health issues with high prevalence. Non-perinatal diabetes mellitus and depression are confirmed to have reciprocal influence, which is bidirectional relationship. However, there are still no any confirmations of relationship in the perinatal period. The reason could be that these kinds of studies mostly had been done for postpartum depression, they had rarely been discussed with a clearly sequential influence between gestational diabetes mellitus and perinatal depression. Additionally, there have not been so many Asian countries which been done this kind of studies, therefore, this study will focus on the relationship of primiparous gestational diabetes mellitus and perinatal depression. Purpose: This study will discuss the bidirectional relationship of gestational diabetes mellitus and perinatal depression. In the other words, the prenatal depression influences on gestational diabetes mellitus, and vice versa. Those changeable factors, such as social support, health behavior, prenatal body index, weight gain during pregnancy, perinatal complications…etc, will be tested for whether they could be regulators or not between the gestational diabetes mellitus and perinatal depression.Afterwards, a part of participants with diagnosis of gestational diabetes mellitus will receive the intervention of health education to influence the health behavior, then depression and other obstetrics and gynecological results will be tested for effects.
Birth/Perinatal asphyxia in Pakistan continues to be a leading cause of neonatal mortality and morbidity. It is estimated that around 80 to 120,000 neonates either suffer from or die from birth/perinatal asphyxia every year. In addition to the large number of deaths a larger number of babies who survive suffer from neuro-developmental disorders adding to the health burden to the society and the nation. To date other than prevention (which requires global efforts to improve maternal education and health care) the therapies available to treat infants who have suffered from birth asphyxia have been either technically too complex or extremely expensive.
In December 2019, infection with a novel coronavirus SARS-CoV-2 emerged in China and has since spread throughout the world. Forms of varying severity of COVID-19, a disease induced by this emerging virus, have been described in pregnant women. In addition to the direct effects of the virus on the pregnant woman and the fetus, the pandemic context itself is likely to act as a psychological risk factor and to alter the protective factors for mental disorders. This pandemic context is in itself anxiety-provoking, even traumatogenic, particularly because of the potentially lethal infectious risk that it carries, all the more so in psychologically vulnerable populations. In addition to the fear of viral contamination, in the perinatal period, the fear of childbirth also includes a more or less important part of anxiety-producing uncertainty. This addition of stress factors is likely to increase the prevalence of perinatal anxiety disorders, particularly psychotraumatic experiences of childbirth and peri-traumatic dissociative states. Health and social measures, such as confinement, restriction of access of accompanying persons to maternity services, or contagious isolation of mothers suspected of being infected or infected, which may furthermore impose a mother-infant separation, are also likely to have psychopathological consequences. Studies specifically concerning the psychological effects of the COVID-19 pandemic context have been published. Among them, the French COVIPREV study, carried out in the general population during the first and second week of the containment period (beginning mid-March 2020), reported a prevalence of anxiety of 26.7% and 21.5% respectively. These prevalences are significantly higher than the usual prevalence estimated at 13.5% in the same population. Many international studies show an increase in the prevalence of postnatal depression in the current pandemic context. In the population of pregnant women, an Italian study on the psychological impact of the COVID-19 pandemic in 100 women in pregnancy, with no psychiatric history, in Naples during the second half of March 2020, found a positive score on the Impact of Event Scale-Revised (IES-R) for more than half of the women and a positive anxiety score on the State-Trait Anxiety Inventory (STAI-S) for 68% of the women The same observation was made in Quebec where two cohorts of pregnant women (between 4 and 41 weeks of amenorrhea) subjected to self-questionnaires evaluating different dimensions of their mental health, a first one recruited before the pandemic phase of 496 women and a second one of 1258 women recruited online between April 2 and 13, 2020, have been analyzed. Women in the second cohort had significantly higher levels of depressive and anxiety symptoms, more dissociative symptoms and post-traumatic stress symptoms. In China, a multicenter study in 25 hospitals in 10 provinces across the country that included 4124 women in the third trimester of pregnancy from January 1 to February 9, 2020, when the epidemic was publicly announced on January 20, 2020, again reported increased levels of anxiety and depressive symptoms on the Edinburgh Postnatal Depression Scale (EPDS) in pregnant women after the announcement compared to before. Finally, similar results are reported by Turkish researchers showing again a high prevalence of depressive symptoms during pregnancy (35.4%) during the COVID-19 pandemic. In the perinatal context, it has been documented that post-traumatic stress disorder is strongly associated with the risk of perinatal depression. In the context of the COVID-19 pandemic, three maternity units of the PREMA University Hospital Federation (FHU PREMA), the Paris Saint-Joseph Hospital Group (GhPSJ), the Louis Mourier Hospital (APHP) and the Port-Royal Maternity Unit (APHP), in partnership with the Boulevard Brune Psychopathology Center (CPBB) and the Psychiatry Department of the Louis Mourier Hospital (APHP), have set up, as of June 2020 a care protocol consisting of a screening offered systematically to women in postpartum at D1 of their delivery, intended to identify those presenting anxiety and depressive perinatal symptoms using the Edinburgh Postnatal Depression Scale (EPDS). Thus, the PsyCOVIDUM project to estimate the prevalence of depressive symptoms in the immediate postpartum period just after delivery at different times during the pandemic episode was initiated in the three FHU PREMA maternity hospitals. This study aims at the constitution of a DNA and serum biobank in voluntary women presenting or not a depression with an antenatal onset identified at the maternity hospital. This collection would eventually allow the evaluation of the role of inflammatory and genetic biological factors in the occurrence of antenatal onset depression on an independent cohort.