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Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.
A randomized controlled trial of impact of wearable, wireless breast pumps on how often and how much milk mothers of premature infants can pump.
Study focuses on determining if daily versus every-other-day (EOD) oral iron at the same dose per kilogram per day will achieve similar incidence of iron replete status at 36 weeks post-menstrual age in premature neonates
Preterm Premature Rupture of Membranes (PPROM) before 37 weeks of pregnancy is responsible for 40% of preterm births in the United States. The PPROM Registry aims to identify possible causes of PPROM, evaluate trends in expectant management, measure maternal and fetal care, and to review short term and long term outcomes of affected pregnancies and births.
Adverse childhood experiences (ACEs) are directly related to cardiovascular morbidity and mortality, and impaired vascular endothelial function (VEF) is an independent predictor of future cardiovascular disease (CVD) risk \[1, 2\]. Previous work from our lab (IRB 202010095) and others \[3\] demonstrates impaired VEF in young adults with prior exposure to ACEs even in the absence of clinical CVD risk factors. Sirtuin 1 (SIRT1) is a class III histone deacetylase (HDAC) that plays a role in regulating vascular homeostasis and reductions in SIRT1 are associated with age-related endothelial dysfunction \[4\]. We have shown that ACEs-related impairments in VEF are accompanied by reductions in SIRT1 \[5\]. However, the mechanisms by which ACE exposure promotes VEF remain unknown. The goal of this project is to establish proof of concept that alterations in vascular SIRT1 expression and activity mediate premature vascular aging in individuals with \>=4 ACEs compared to those with 0 ACEs and that, because NAD+ is an essential substrate for SIRT1, increasing NAD+ bioavailability will restore VEF in those with \>=4 ACEs. Thus, we will use a robust translational approach coupling in vivo and in vitro measures of endothelial function, inflammation, oxidative stress, and SIRT1 expression and activity in young adults with (n=30-35) versus without (n=30-35) ACE exposure in a cross-sectional study, and during a randomized controlled trial employing a novel 4-week nicotinamide riboside (NR) supplementation approach to increase SIRT1 activity by increasing cellular NAD+ in ACE+ (n=15/group) to accomplish the following specific aims: 1. Determine the mechanisms by which ACE exposure alters the regulation of VEF by SIRT1. We hypothesize that compared to those without ACEs (ACE-), ACE+ will have (H1a) elevated endothelial oxidative stress and inflammation, (H1b) accompanied by reduced endothelial SIRT1 expression and increased p66SHC expression and acetylation of p65 and p53, (H1c) in association with lower VEF. 2. Determine how targeting SIRT1 by increasing NAD+ bioavailability affects VEF in young adults with ACEs. We hypothesize that systemic NR supplementation will (H2a) augment cellular SIRT1 activity and (H2b) improve VEF in ACE+. \[1\] Felitti, V.J., Anda, R.F., Nordenberg, D., Williamson, D.F., Spitz, A.M., Edwards, V., Koss, M.P., \& Marks, J.S. (1998). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The adverse childhood experiences (ace) study. American Journal of Preventive Medicine, 14(4), 245-258. https://doi.org/10.1016/S0749-3797(98)00017-8. \[2\] Jenkins, N.D.M., \& Robinson, A.T. (2022). How do adverse childhood experiences get under the skin to promote cardiovascular disease? A focus on vascular health. Function (Oxf), 3(4), zqac032. PMC9279110. 10.1093/function/zqac032. \[3\] Rodriguez-Miguelez, P., Looney, J., Blackburn, M., Thomas, J., Pollock, J.S., \& Harris, R.A. (2022). The link between childhood adversity and cardiovascular disease risk: Role of cerebral and systemic vasculature. Function. 10.1093/function/zqac029. \[4\] Thompson, A. M., Wagner, R., \& Rzucidlo, E. M. (2014). Age-related loss of SirT1 expression results in dysregulated human vascular smooth muscle cell function. American Journal of Physiology-Heart and Circulatory Physiology, 307(4), H533-H541. \[5\] Jenkins, N.D.M., Rogers, E.M., Banks, N.F., Tomko, P.M., Sciarrillo, C.M., Emerson, S.R., Taylor, A., \& Teague, T.K. (2021). Childhood psychosocial stress is linked with impaired vascular endothelial function, lower sirt1, and oxidative stress in young adulthood. Am J Physiol Heart Circ Physiol, 321(3), H532-H541. PMC8461842. 10.1152/ajpheart.00123.2021
Background: Premature ovarian insufficiency (POI) is a condition in which women under the age of 40 years have absent or irregular menstrual cycles. POI can cause infertility, signs of menopause, osteoporosis, and other symptoms. Hormone replacement therapy (HRT) is a treatment that gives women extra hormones, such as estrogen and progesterone. HRT works well in adult women. Researchers want to find the most effective doses and regimens for adolescents. Objective: To monitor the effects of HRT on adolescents with POI. Eligibility: Female adolescents aged 11 to 19 years diagnosed with POI. Healthy volunteers are also needed. Design: All participants will have clinic visits every 6 months for 2 years. Each visit may last 2 days. Each visit may include: Blood and urine tests. A test of their heart function. A test to measure the stiffness of their blood vessels. Participants will lie flat with a blood pressure cuff on a leg and a meter on the neck while the cuff inflates. A test of their grip strength. Participants will squeeze a handheld device as hard as they can. Two scans to measure bone density. For one, participants will lie on a table while a scanner passes along their body. For the other, participants will sit in a chair and insert their forearm, then their lower leg, into a scanner. A test to measure skin pigmentation. Participants skin will be touched lightly with a device. An optional visual exam of the vagina. Some vaginal fluid may also be collected with a cotton swab/cytobrush. Participants with POI will receive HRT. They will be given estrogen patches and progesterone pills.
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants over a period of 6 months.
A prospective sham-controlled randomized clinical trial to assess the effect of low-level tragus stimulation (LLTS) in patients with frequent premature ventricular complexes (PVCs)
The purpose of this study is to design, develop, validate and pilot test an interactive Maternal Resuscitation Navigation Application (MARINA) for the purpose of providing information and guidance about the expected events that a premature infant will experience during initial resuscitation upon delivery. This information will be shared via computer app prior to the time that the mother would be in distress due to active labor. The application will be pilot tested for functionality, usability and feasibility of future use and research in clinical settings. Focused aspects of the application will include simulated video of the active delivery environment, explanation of each team member's role in resuscitation and specific activities involved in premature infant resuscitation. To assure the application addresses key information mothers would desire, the application will include content developed with input from a consulting group of mothers who have experienced premature infant resuscitation in the delivery room. Additionally, prior research by the research team will inform the build of this application. The application will have the ability for mothers to choose whether to view close up procedures (bag/mask positive pressure oxygen delivery, intubation, line placement, etc.). She may alternatively select to only view the broader view of the room while listening to the description of activities occurring at that time. The mother will be able to choose her level of interactivity depending on her comfort level. The application will go through multiple levels of testing throughout the development process. After an iterative process, when the research team finds the application acceptable, a small group of consulting parents and experienced clinicians will review the application for functionality (ease of use) and content validity. Aim 2: To pilot test the functionality, usability and feasibility of the interactive Maternal Resuscitation Navigation Application (MARINA) for future use and research in clinical settings to reduce maternal distress associated with premature infant resuscitation.
Background: Turner Syndrome, galactosemia, and premature ovarian insufficiency are all conditions that may make it very hard or impossible for a person to become pregnant and have their own child. Researchers want to learn more about why this happens and if freezing Gonadal tissue allows for fertility preservation. Objective: To find out why people with certain conditions have can have premature ovarian insufficiency (POI or early menopause) and individuals with variations in sex characteristics have trouble getting pregnant and if freezing the gonads tissue from them will help to have their own child in the future. Eligibility: Individuals aged 2-21 who have Turner Syndrome or galactosemia. Also, females aged 13-21 with premature ovarian insufficiency, individuals with variations in sex characteristics, and individuals 2-35 receiving high-risk gonadotoxic therapy Design: Participants will be screened with a medical history. Participants may have a physical exam and blood tests. Their body measurements may be taken. These include weight, height, arm span, skin fold, and sitting height. They may fill out surveys about their quality of life, body image, and health. Participants may have a transabdominal pelvic ultrasound. A probe will be placed on their belly and will take pictures of the organs in the pelvis. They may have a transvaginal pelvic ultrasound performed while asleep in the operating room if needed. Participants may have surgery to remove an gonads and skin biopsy. The removed tissue will be frozen and stored. The tissue will have to be stored for many years. NIH will pay to store the tissue for 1 year. After that, participants will have to pay for storage. A piece of the gonads (no more than 20%) will be used for research Travel, lodging and meals for participants traveling greater than 50 miles will be reimbursed based off the government rate. Local participants will not be reimbursed. Participants will have a checkup 6 weeks after surgery one or more follow-up visits 6-18 months after surgery. They may have phone follow-up every 12-24 months after surgery. Participation will last 30 years.