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Premature Birth clinical trials

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NCT ID: NCT04617717 Recruiting - Clinical trials for Ventricular Premature Complexes

Personalized Treatment for Patients With Premature Ventricular Beats

Start date: September 30, 2020
Phase:
Study type: Observational

Frequent premature ventricular beats (PVBs) are common, negatively affects the quality of life for many patients, and can lead to impaired contractile function. Rule-out of structural heart disease is key in the assessment of PVBs. Cardiac MR has a high sensitivity for structural heart disease, but the diagnostic gain from this resource-demanding procedure in the work-up of patients with PVBs is unknown. There is a need to establish the role of MR in the evaluation of patients with PVBs to improve diagnostic efficacy, establish treatment strategies, and promote further research. This project will answer three key questions: 1) What is the diagnostic gain from cardiac MR in patients with PVBs? 2) Is MR the real gold standard to rule-out structural heart disease in patients with PVBs? 3) Can non-invasive heart rate parameters guide the strategy for induction of PVBs during invasive electrophysiological procedures?

NCT ID: NCT04613167 Recruiting - Inflammation Clinical Trials

Markers of Cardiovascular Risk in Patients With Premature Coronary Artery Disease and Treatment

GEBI
Start date: November 10, 2020
Phase: N/A
Study type: Interventional

The aim of study is to examine the relationship between lipid subfractions, inflammation and structural-functional properties of the arterial wall in patients with premature coronary heart disease, to study genetic polymorphisms that determine lipid subfractions concentration on the functional and morphological properties of the arterial vascular wall in patients with early coronary heart disease, to study the effect of alirocumab and evolocumab on lipid subfractions, inflammation and structural-functional properties of arterial wall in patients with early coronary atherosclerosis and to study the influence of NOS-3 gene expression on the functional and morphological properties of the arterial vascular wall in the same patients. Impaired blood fat metabolism and chronic inflammation are intertwined as possible causes of atherosclerosis. Lipoprotein (a) (Lp (a)) is an important risk factor for coronary heart disease and a prognostic predictor in patients after myocardial infarction, but recent research suggests that subtilisin-kexin convertase type 9 (PCSK9) inhibitors are the only drugs that significantly reduce serum Lp (a) concentration. However, there are no data on the relationship between Lp (a) values and polymorphisms for Lp (a), indicators of inflammation and impaired arterial function, and response to treatment with various PCSK9 inhibitors in patients with early coronary heart disease.

NCT ID: NCT04595214 Recruiting - Premature Birth Clinical Trials

Develop a Multi-disciplinary Approach for a Personalized Prenatal Diagnostics and Care for Twin Pregnancies

PRETWINSCREN
Start date: December 21, 2020
Phase:
Study type: Observational [Patient Registry]

Different screening modalities evaluation to develop algorithms to predict pregnancy complications in twin pregnancies, and evaluation of serologic response to BNT162b2 Pfeizer/BioNTech vaccination.

NCT ID: NCT04593498 Recruiting - Atrial Fibrillation Clinical Trials

Excessive Supraventricular Activity and Atrial Fibrillation

ESA-AF
Start date: November 1, 2022
Phase:
Study type: Observational

The aim of the proposed study is to determine if individuals with excessive supraventricular ectopic activity (ESVEA) on Holter recording should be subjected to prolonged screening with Event loop recorder in order to detect previously undiagnosed Atrial fibrillation / flutter. Other biomarkers such as plasma biomarkers, high-end echocardiography and assessment of blood pressure and atrial stiffness will be studied and compared in ESVEA and control group as well as progression of atrial cardiomyopathy in ESVEA patients.

NCT ID: NCT04590677 Recruiting - Preterm Birth Clinical Trials

Prediction of the Onset of Term and Preterm Labour

PREDICT
Start date: October 20, 2020
Phase:
Study type: Observational

This study will collect samples from pregnant women in order to identify biomarkers that relate to onset of spontaneous preterm labour.

NCT ID: NCT04578522 Recruiting - Clinical trials for Premature Coronary Heart Disease

Correlation Between the Severity of Coronary Artery Disease and Peripheral Arterial Stiffness in Patients With Premature Coronary Heart Disease

Start date: September 29, 2020
Phase:
Study type: Observational

Premature coronary heart disease (CHD) refers to the onset of myocardial infarction in men < 55 years old, women < 65 years old. At present, researches on early-onset coronary heart disease mostly focus on its risk factors and clinical characteristics, but there is no relevant research on the relationship between early-onset myocardial infarction and atherosclerosis.

NCT ID: NCT04565210 Recruiting - Premature Clinical Trials

Effects of Oriental Music on Preterm Infants

Start date: October 15, 2020
Phase: N/A
Study type: Interventional

The goal of this study is to explore the effect of oriental music on premature infants' physiological and behavioral parameters during their hospital stay in the NICU.

NCT ID: NCT04562909 Recruiting - Premature Birth Clinical Trials

Evaluation of Postural Control in Premature Children

Start date: September 1, 2020
Phase:
Study type: Observational

To date, it is largely unknown whether preterm children experience balance problems and whether they have normal postural control. Assuming that postural adaptation is affected after preterm delivery because it depends on attention and fine motor control, the postural control and motor development of children born preterm less than 32 weeks in the 5-7 age period will be affected compared to their healthy controls. Identifying these situations according to their healthy peers will improve the general health of premature births and enable better intervention methods to be designed.

NCT ID: NCT04555590 Recruiting - Clinical trials for Parent-Child Relations

Implementation of an Evidence Based Parentally Administered Intervention for Preterm Infants

Start date: November 16, 2020
Phase: N/A
Study type: Interventional

Early developmentally-based behavioral intervention has well-established positive effects and is recommended as the standard of care to support early brain maturation, health, and development. However, few neonatal intensive care units (NICUs) provide this early intervention. H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) has established efficacy, and has a standardized protocol, making it ready for widespread implementation. The infant-directed component of H-HOPE provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation starting when infants are ready for social interaction. The parent-directed component of H-HOPE includes participatory guidance and support to help parents engage with infants in the NICU and the transition to home. In this NIH-funded research, H-HOPE improved growth, developmental maturity and mother-infant interaction, and reduced initial hospitalization costs and acute care visits through 6-weeks corrected age. This research tests whether H-HOPE can be implemented and sustained in five diverse NICUs, using a Type 3 Hybrid design to evaluate both implementation processes and effectiveness. The specific aims are to: 1) Identify the degree of implementation success; 2) Evaluate the effectiveness of H-HOPE for infants, hospital costs from H-HOPE enrollment until discharge, and parents, compared to a pre-implementation comparison cohort; and 3) Determine influences (facilitators and barriers) associated with implementation success and H-HOPE effectiveness, guided by the Consolidated Framework for Implementation Research (CFIR). An incomplete stepped-wedge design guides staggered roll-out for five clinical sites. Each NICU completes the CFIR implementation steps (Planning and Engaging, Executing, and Reflecting and Evaluating), followed by 6 months of Sustaining. For Aim 1, degree of implementation success is determined every two months as Sustainability (still offering H-HOPE), Reach (% of eligible parent/infant dyads receiving H-HOPE) and Degree of Implementation (mean H-HOPE services received per parent-infant unit) (primary implementation outcomes). For Aim 2, effectiveness is analyzed using generalized linear mixed models for infant, cost, and parent outcomes (primary outcomes: infant growth at discharge and acute care visits from discharge to 6-weeks corrected age). Propensity score analysis is used to make the pre- and post-implementation comparable. For Aim 3, a mixed methods analyses is used to identify influences from H-HOPE records and interviews that are associated with implementation success and effectiveness at each site and across sites. This is the first time implementation in a NICU is guided by the evidence-based CFIR framework, and results will make a major contribution to implementation science. This study will produce an evidence-based implementation strategy and Toolkit to disseminate nationwide. Widespread H-HOPE implementation will make a significant change in clinical practice and improve preterm infant health and health care costs.

NCT ID: NCT04542148 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes

Start date: February 10, 2022
Phase: Phase 2
Study type: Interventional

There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB.