View clinical trials related to Neonatal Asphyxia.
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.
Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a "Treatment for hypoxic-ischemic encephalopathy in neonates," which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.
Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour. Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs. Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.
The study aims are to evaluate the impact of supportive follow-up strategies for a novel twinned training and capacity-sustaining program among frontline health workers (providers) attending facility-based births in remote and district level health facilities in Uganda. The program is designed to improve provider competencies, provider performance and health outcomes among women giving birth and newborns.
This is an historic cohort study based on the birth and delivery register of the HFME maternity ward. This study aim at understanding the evolution of asphyxia at birth, at all gestational ages, identifying causes and describing neonatal outcomes since 2000, when a second line strategy for foetal surveillance (fetal ECG) and systematic umbilical acid-gas cord blood were introduced in our maternity ward. The investigator's hypothesis was that the neonatal asphyxia decrease could be due to 3 main factors including second line strategy introduction, systematic umbilical cord acid-base implementation and improvement in antenatal risk factor screening for asphyxia. The investigator's second hypothesis was that neonatal prognosis in neonates with acidosis was improved with systematic early after birth EEG evaluation, allowing early treatment and surveillance.
Background: About 10% of all newborns may have difficulty breathing and require support by trained personnel. In Peru, 90% of deliveries occur in health facilities; however there is not a national neonatal resuscitation and certification program for the public health sector. In addition, the Andes and the Amazon regions concentrate large rural remote areas, which further limit the implementation of training programs and the accomplishment of continuous certification. Neonatal resuscitation training through the use of information, communication and technology (ICT) tools running on a computer, tablet or mobile phone may overcome such limitations. This strategy allows online and offline access to educational resources, paving the way to more frequent and efficient training and certification processes. Objective: To evaluate the effects of a neonatal resuscitation training and certification program that uses a multi-platform ICT (MP-ICT) strategy on neonatal health care in remote areas. Methods: The investigators propose to conduct the study through a cluster-randomized trial, where the study and analysis units are the health care facility. Eligible facilities will include primary and secondary health care level facilities that are located in provinces with neonatal mortality rates higher than 15 per 1,000 live births. The investigators will compare the proportion of newborns with a heart rate ≥100 beats per minute at 2 minutes after birth in health care facilities that receive MP-ICT training and certification implementation, with those that receive conventional training and certification. Discussion: The investigators expect that the intervention show to be more effective than the current standard of care. The investigators are prepared to include it within a national neonatal resuscitation training and certification program to be implemented at national scale together with policymakers and other key stakeholders.
The overall objective is to determine whether a bundled In-hospital Newborn Resuscitation Edu-cation intervention (INSPIRE-D) improves process of care associated with improved newborn survival and neurologic outcomes.