View clinical trials related to Preterm Birth.
Filter by:The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1. Can cell-free RNA-based biomarkers predict which pregnant people are at greatest risk of developing adverse pregnancy outcomes (e.g., preterm birth, preeclampsia)? 2. What is the performance of such biomarkers when predicting an adverse pregnancy outcome (e.g., sensitivity, specificity, PPV, NPV, TPR)?
Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated. Previous preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth. Infections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation). Synbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.
This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.
Neonatal intensive care relies on indwelling plastic medical devices fundamental in respiratory support, intravenous catheterization, and nutrition. While being in a critical developmental period, constant exposure to these invasive medical devices puts premature neonates at risk of plasticizers' potential toxicity. Despite novel regulations and development of alternative plasticizers (AP), reference to guide manufacturers and an overview of the prevailing exposure levels to DEHP or alternatives in the neonatal intensive care unit (NICU) are still missing. The three main objectives of this project are: (1) to assess current exposure to plasticizers in the NICU, (2) to identify the sources of exposure and (3) to study the resultant long-term health risk in premature neonates. These objectives are addressed in three work packages (WP). In work package 1, in vivo exposure of premature neonates to phthalates and alternative plasticizers is assessed by determining their metabolites in biological matrices (urine and hair). Work package 2 explores ex vivo leaching characteristics of different plasticizers from medical devices used in the NICU. Finally, Work package 3 studies the long-term neurocognitive and lung development in relation to plasticizer exposure in the NICU.
This is a cross-sectional study of a randomized clinical trial to investigate nutritional aspects of pre-scholar aged children born preterm submitted to an early stimulation program versus conventional care program. The preterm-born children participated in the project entitle "Early Intervention Program for Preterm Infants and Their Parents: establishing the impact at 18 Months Corrected Age" (NCT02835612), which performed a continuous early stimulation in very and extremely preterm infant's families in their first 12 to 18 months. In the present study, preterm born children currently with 3 to 6 years old and their mothers (or legal guardian) are once more invited to a one-day visit for a nutritional and clinical evaluation at the Clinical Research Center of Hospital de Clínicas de Porto Alegre/Brazil. In the consultation, preterm born children and theirs mothers are submitted to the following exams: body composition by electrical bioimpedance, clinical and physical evaluation, anthropometric measurements, and children's eating habits, eating behavior and parental educational style in food through specific questionnaires. Moreover, this study will also investigate a group of pre-scholar health children born at term to obtain reference values for variables analysed. The goal with these findings is to determine if an early stimulation program could present a positive impact in anthropometric outcomes and nutritional aspects in this more vulnerable preterm born population.
Data on parent-infant physical closeness and infants' auditory environment will be collected among preterm infants when they are at gestational age of 32 to 34 weeks. The follow-up includes eye-tracker test at 7 months of corrected age for face preferences of the infants and simultaneously parents' eye movements and pupil diameter responses. During the second year, the follow up includes MacArthur Communicative Development Inventories (lexical development) at 12 and 24 months of age; language development test (Reynell Developmental Language Scales III) and developmental test (Bayley Scales for Infant development Edition III) at 24 months of corrected age.
Pregnant women are a vulnerable and high-risk population, as COVID-19 is associated with an increased risk preterm birth, cesarean section, and maternal critical care. This study will examine the factors that impede testing for SARS-CoV-2 (the causative virus among pregnant women), help determine optimal testing strategies by evaluating the necessity of testing for asymptomatic disease in pregnancy, inform prenatal care plans by assessing the full impact of infection, and contribute to a provider's ability to counsel women and create prenatal care plans if they are pregnant or considering pregnancy.
Yearly 15 million babies worldwide are born too soon. 10% of these preterm births occur very early before 32 weeks of gestation and these newborns are at high risk for neurodevelopmental disorders later in life. Neurocognitive disorders now touch 27% of the European population, and 5% or 3.3 million children suffer from social and learning difficulties, including attention-deficit hyperactivity disorders and autism, whose rates are increasing and prematurity contributes to this rise. Cognition, and socio-emotional competence are based on intact brain structure and functions that are formed early in development, both pre- and post-natally, and are heavily influenced by environment. Ramon y Cajal in his studies on the making of the brain clearly stated: "The total arborisation of a neuron represents the graphic history of conflicts suffered during its developmental life". Understanding how environment affects early brain development and defining timing and mode of early interventions to enhance brain development in high risk populations, such as preterm infants, is currently acknowledged as a fundamental endeavor for the scientific community (see guidelines of the National Scientific Council for the Developing Child). Interventions to improve and maintain cognitive and socio-emotional skills are to become an essential tool of medical care for high-risk infants. The goal of this study is to test the impact of a Mindfulness-based intervention - considered to target brain networks previously described as affected by prematurity and improve socio-emotional and executive functions. Mindfulness based intervention (intentional self-regulation of attention) will be performed in 10-13 year old preterm children, both from our prior studied preterm cohorts. Overall, our planned research will fill an important gap in our theoretical understanding of the brain vulnerability linked to prematurity. Even more importantly, the compelling issue of how to build cognitive and emotional resilience in preterm children will be addressed by preventing the onset of difficulties and reducing them with appropriate interventions.
The early birth of a premature baby can be a devastating and unplanned situation for parents. Often, their baby cannot be readily held; they can be very sick and fragile. Parents can feel helpless; bonding may be more difficult, parental control is superseded by medical necessity and parents can feel tremendous guilt whenever they are unable to be present at their baby's bedside. The investigators believe that giving parents an opportunity to provide comfort in the form of the mother's voice, pre-recorded and played to her baby, will improve her feeling about her baby in the NICU. The investigators hypothesize that playing the mother's recorded voice to her extremely preterm infant while in the incubator when she cannot be present will improve the depression, anxiety and stress as well as overall feeling about her baby. The investigators will assess the change in depression, anxiety and stress with the use of a validated tool (the DASS21), as a result of the intervention. The investigators will also assess the improvement of her feelings with a questionnaire () to be administered before and after the intervention. The investigators predict that her depression, anxiety and stress as well as positive feeling will increase after the intervention. The investigators also predict that the infant's vital signs will remain stable and/or improve when the recording is played.
This prospective, randomized, controlled study evaluates the safety and efficacy of a preterm birth (PTB) prevention strategy versus standard of care pregnancy management to reduce the incidence of adverse pregnancy outcomes.