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Premature Birth clinical trials

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NCT ID: NCT03696758 Completed - Infant,Premature Clinical Trials

Improving Right Ventricular Function in Young Adults Born Preterm

Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.

NCT ID: NCT03689166 Completed - Preterm Birth Clinical Trials

Effect of Probiotics on the Preterm Delivery Rate in Pregnant Women at High Risk for Preterm Birth

PROPEV
Start date: October 23, 2017
Phase: N/A
Study type: Interventional

Preterm birth (PB) continues to be the main cause of perinatal morbidity and mortality, with emotional and economic consequences. Despite improvements in health, PB prevalence remains stable, possibly due to complex causes such as maternal age, stress, multiparity, etc. Shortening of the uterine cervix in early stages of gestation is a risk factor for PB. The presence of abnormal vaginal microbiota in the early stages of pregnancy is als a risk factor for PB. However, no studies have analysed the impact of probiotics (live microorganisms which, in adequate amounts, confer a health benefit on the host) on the PB in high-risk PB patients (pregnant women with threatened preterm delivery, i.e., uterine contractions and cervical shortening, with a 30% PB risk before 34 weeks, and 50% PB prior to 37 weeks (> 6-10% PB). Similarly, the effect of probiotics on vaginal flora dominated by lactic acid-producing bacteria could be analysed.

NCT ID: NCT03680157 Completed - Premature Birth Clinical Trials

Comparing Rater Reliability of Familiar Practitioners to Blinded Coders

Start date: September 30, 2018
Phase:
Study type: Observational

The purpose of this study is to determine how coders who have seen multiple time points of the same dyad, and are therefore familiar with the case, rate emotional connection using the WECS compared to coders who are blinded to the case's previous time points. The investigator hypothesizes that the WECS will show external validity: that all coders will have high reliability on their WECS scores, despite exposure to the dyads' past videos by the clinical coders.

NCT ID: NCT03680001 Completed - Premature Birth Clinical Trials

Students Education Training in Emotional Connection

Start date: September 14, 2018
Phase:
Study type: Observational

The purpose of this study is to assess the effectiveness of different educational modules in training graduate students from Columbia University Irving Medical Center campus and from the Columbia School of Social Work to assess the emotional connection of mother/child dyads with accuracy. The investigators hypothesize that after completing the educational module involving recorded dyad interactions, subjects will achieve coding reliability with the PI.

NCT ID: NCT03677908 Completed - Premature Birth Clinical Trials

Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous

NEURONAUX
Start date: July 1, 2016
Phase:
Study type: Observational

Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.

NCT ID: NCT03677752 Completed - Child Development Clinical Trials

GP_Posit Intervention for Mothers of Preterm Infants for Maternal Sensitivity : Randomized Pilot Trial

GP_Posit
Start date: August 20, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the acceptability, feasibility and preliminary effects a GP_Posit intervention. GP_Posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. Preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.

NCT ID: NCT03675061 Completed - Pregnancy Preterm Clinical Trials

Evaluation of Vaginal PAMG-1 Detection by PartoSure Test in Preterm Delivery Threat in Actual Clinical Situation: Randomized Controlled Trial

PARTO-MAP
Start date: December 11, 2018
Phase: N/A
Study type: Interventional

Prematurity is defined as birth before 37 weeks of amenorrhea. It is the leading cause of perinatal morbidity and mortality. It is estimated that premature births to 15 million worldwide in 2010, including 60,000 children in France (7,4% of births) and 12000, born before 32 weeks of amenorrhea (term defining great prematurity). More than half of these births follow spontaneous work. Before 34 weeks of amenorrhea, prematurity requires specific maternal-fetal management centered primarily on antenatal corticosteroid treatment for fetal maturation including 2 intramuscular injections at 24 hour intervals. This cure can only be done once and its benefit is proven in the 7 (to 14) days before the birth (recommendation for the clinical practice of the French National College of Obstetricians and Gynecologists of December 2016). The single course of antenatal corticosteroids before 34 weeks of amenorrhea is associated in the neonatal period with reduction in morbidity and mortality, and in the long term with an improvement of the survival without sequelae, if the full cure is administered in the 7, to 14, days before birth. The second key element of the management of a premature delivery threats is the admission in a pediatric structure adapted to the degree of prematurity. The care of a premature delivery threats before 34 weeks of amenorrhea care leads to hospitalization with possible transfer to a maternity of pediatric adapted level, tocolysis, a biological and bacteriological assessment, and, sometimes, other examinations and treatments. The prediction of premature labor is a challenge. Current methods, such as vaginal examination, cervicometry and detection of fetal fibronectin, make it possible to obtain a negative predictive value (NPV) approaching 100% but a poor positive predictive value (PPV), thus 8 out of 10 patients hospitalized and treated for premature delivery threat no not give birth within 7 days, or even before 34 weeks of amenorrhea. A better prediction of preterm delivery has two benefits: administer antenatal corticosteroid therapy in high-risk patients at the right time and not treat not-at risk patients. The PartoSure® test, which detects the placental protein vaginal alphamicroglobulin-1 (PAMG-1), has satisfactory metrological qualities according to observational studies : NPV 98% and PPV 75% of delivery within 7 days. However this test has never been evaluated in real clinical condition. In our study, the result of the test becomes decisional for the care. The hypothesis is that use of this test will improve the prediction of preterm delivery during a first consultation for preterm delivery threat and thus allow more frequent prenatal corticosteroid treatment in optimal period, avoiding treating non-at risk patients.

NCT ID: NCT03671759 Completed - Clinical trials for Premature Ventricular Contractions

Coffee and Real-time Atrial and Ventricular Ectopy

CRAVE
Start date: May 1, 2019
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) and heart failure (HF) are morbid, costly, and incompletely understood diseases that have reached epidemic proportions worldwide. A dose-dependent relationship exists between premature atrial and ventricular contractions (PACs and PVCs) and development of AF and HF, respectively. Identifying and understanding the mechanisms of additional modifiable risk factors for ectopy has the potential to markedly reduce the healthcare burden of these diseases. In considering how to modify the prevalence of these ectopic beats, the investigators believe common exposures in daily life are prime candidates. Current guidelines suggest that caffeine may be an important trigger for frequent ectopy, although large population-based studies have not demonstrated an association between caffeine consumption and development of clinically significant arrhythmias. No study has employed an actual randomization intervention to assess the effects of caffeine on cardiac ectopy. Utilizing the Eureka platform, the investigators plan to utilize the N-of-1 strategy to rigorously investigate the real-time effect of caffeine intake on ectopy.

NCT ID: NCT03668860 Completed - Preterm Birth Clinical Trials

India Dexamethasone and Betamethasone

Start date: September 20, 2018
Phase: Phase 1
Study type: Interventional

An open label, randomized, two-period, crossover, study to compare the pharmacokinetics and pharmacodynamics of single dose Dexamethasone and Betamethasone administered orally and intramuscularly in 48 healthy, adult, female subjects under fasting conditions. This study is being conducted in Bangalore, India.

NCT ID: NCT03668626 Completed - Premature Birth Clinical Trials

Family-Centered Intervention for Preterm Children: Effects at School Age and Biosocial Mediators

Start date: October 17, 2018
Phase: N/A
Study type: Interventional

This study is to extend our previous research to longitudinally examine the effectiveness of intervention programs (FCIP and UCP) for VLBW preterm children in Taiwan at seven years of age. Gender and maternal education level matched term children will also be included to serve as the reference group for comparison of developmental outcomes. The intervention had been delivered from birth to one year of corrected age in the previous study. Effectiveness examined will include child and parent outcomes. Primary outcome refers to measures of child neurobehavioral and neurophysiological functions. Neurobehavioral assessment includes cognitive, motor and behavioral measurement. Neurophysiological assessment refers to electroencephalogram/event-related potential examination and cognition/motor dual tasks that will be used to investigate the neurological pathways underlying the effective intervention. Secondary outcomes refer to child growth and health, and the quality of parenting measures.