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Premature Birth clinical trials

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NCT ID: NCT02989116 Recruiting - Preterm Birth Clinical Trials

Executive Training and Brain in Children

APEX
Start date: October 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a daily executive training to cognitive inhibition, working memory or mindfulness as compared to an active control condition has a near- and far-transfer impact on brain and behavioral measures as collected in children aged 9-10 years, either born preterm or full-term.

NCT ID: NCT02983240 Recruiting - PreTerm Birth Clinical Trials

Electrical Inhibition of Human Preterm Contractions

Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to explore a new method to stop preterm uterine contractions using an electrical device. The device, an "electrical pacemaker for the uterus," has been approved by the Food and Drug Administration (FDA) for clinical research in pregnant women. The purpose of this study is to evaluate the feasibility and safety of the device. The investigators hypothesize that human preterm uterine contractions can be safely and objectively inhibited with a weak electrical current provided by an electrical inhibition (EI)/uterine pacemaker device, and that this effect relates to the timing and length of EI exposure.

NCT ID: NCT02977000 Recruiting - Clinical trials for Retinopathy of Prematurity

Oral Propranolol Improve Retinopathy of Prematurity Outcomes in Very Preterm Infants

Start date: May 2016
Phase: N/A
Study type: Interventional

Retinopathy of prematurity (ROP) is a major cause of blindness and visual impairment in children in both developing and developed countries around the world. ROP is a multifactorial disease characterized by perturbation of normal vascular development in the retina. The pathogenesis of ROP is hypothesized to consist of two distinct phases of which the second phase is characterized by hypoxia-induced up-regulation of vascular endothelial growth factor (VEGF) and retinal neovascularization. Recent studies have shown a relationship between the β-adrenergic system and angiogenesis. This relationship has been observed in several diseases, like infantile hemangiomas, ROP, and neoplasias. Studies in animal models have shown that norepinephrine stimulates VEGF expression and secretion in retinal cells. In oxygen induced retinopathy, blockage of β-adrenergic receptors (β-AR) can inhibit the angiogenic cascade and interfere with further proliferation of retinal vasculature. Also, angiogenesis seems to be impaired in β-Argene deficient mice, when exposed to hypoxia and other stimuli, but this function is restored after gene therapy. Assuming in human preterm newborns with ROP that VEGF overexpression and retinal neovascularization in response to hypoxia might involve b-AR activation, we design prospective randomized study to assess the effect of oral propranolol on the progression of early stages of ROP in very low birth weight infants.

NCT ID: NCT02923973 Recruiting - Preterm Birth Clinical Trials

Transvaginal Ultrasound Cervical Length Screening in Singleton Pregnancy With Prior Spontaneous Preterm Birth

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

Preterm birth (PTB) is the major cause of perinatal morbidity and mortality. Worldwide, about 15 million babies are born too soon every year, causing 1.1 million deaths, as well as short- and long-term disability in countless survivors. Few prognostic tests are available to predict PTB. A short transvaginal ultrasound cervical length (TVU CL) has been shown to be a good predictor of PTB.Different strategies have been adopted for prevention of PTB. The evidence supports the use of vaginal progesterone in singleton pregnancies with short cervix, while cervical cerclage seems to be beneficial only in the subgroup of singleton gestations with both prior spontaneous PTB and TVU CL ≤25mm, and not in singletons without prior PTB, nor in multiple gestations. However, so far there are no level-1 data on the efficacy of TVU CL screening neither in low risk nor in high risk pregnancy Thus, the investigators aim to assess the efficacy of a policy of TVU CL screening in singleton pregnancy with prior spontaneous PTB

NCT ID: NCT02904070 Recruiting - Premature Delivery Clinical Trials

Interest of Placental Alpha-microglobulin-1 Detection Test to Assess Risk of Premature Delivery in Reunion Island

PARTOSURE-OI
Start date: March 2014
Phase: Phase 4
Study type: Interventional

Prematurity is the leading cause of mortality and perinatal morbidity. Despite the many preventive measures and use of tocolytic therapy, the incidence of premature births has not decreased in recent decades. In 2010 the preterm birth rate (single child, born alive) was still 5.5% in France and 11% in the population of Reunion. In 50% of cases, premature birth is related to spontaneous premature labor layout without rupture of amniotic membranes, called threat of premature birth.The threat of premature birth, defined by the combination of cervical modifications and regular and painful uterine contractions from 22 weeks of amenorrhea and 36 weeks of amenorrhea + 6days, is the major cause of hospitalization in pathological pregnancies services. But all threat of premature delivery situations do not cause premature delivery. In our service, only 30% of patients hospitalized for threat of premature delivery give birth prematurely in accordance with published international data. The diagnosis of threat of premature delivery is difficult and it is still not possible to differentiate a "false labour" of a "real labour". Currently the diagnosis of threat of premature delivery in routine is based on the combination of vaginal examination, the ultrasound, cervical length, but this strategy lacks specificity. In absence of prognostic tool for predicting more reliably the risk of premature delivery in situation of threat of premature delivery, the medical cares are maximalist.: hospitalization, conducting paraclinical investigations, prescription of tocolytics treatments and conducting antenatal corticotherapy. it seems particularly necessary to identify more efficient prognostic criteria that the clinic and ultrasound for judging the severity of threat of premature delivery in other words to predict the risk of premature delivery to adapt and adjust the care of patients after diagnosis of threat of premature delivery.

NCT ID: NCT02844205 Recruiting - Premature Newborn Clinical Trials

Reproducibility of a New Practical Newborn Behavioral Observation Scale

Start date: November 2015
Phase: N/A
Study type: Observational

Neonatal intensive care is necessary for the survival of preterm baby. Several studies show the deleterious effect on the immature brain due to stimulations caused by the environment and hospital care. However, a specific and individualized support to the development during the first weeks of this preterm patient has a positive effect on newborn development. A new practical newborn behavioral observation scale has been developed by the investigators care unit in order to adapt care and individualized support to the development for each patient. The goal of this study is to estimate the external reproductibility of this scale by experimented nurse in order to implement an individualized care program.

NCT ID: NCT02842190 Recruiting - PreTerm Birth Clinical Trials

NIPPV Versus Bi-level Nasal Continuous Positive Airway Pressure Following Extubation

Start date: January 15, 2016
Phase: N/A
Study type: Interventional

Mechanical ventilation is important in the care of preterm infants with respiratory failure, but may be associated with lung injury. Efforts are needed to avoid or minimize the use of mechanical ventilation. However, there is no consensus on the best non-invasive ventilation mode after extubation in preterm infants. Objective: To compare the effectiveness of nasal intermittent positive pressure ventilation (NIPPV) versus bi-level nasal continuous positive airway pressure (BIPAP) following extubation in preterm infants ≤ 1250 g birthweight.

NCT ID: NCT02841813 Recruiting - Preterm Birth Clinical Trials

Effects of Genomic and Metabolomic Variations of Choline on Risk of Preterm Birth and Clinical Outcomes in Preterms

Start date: March 2016
Phase: N/A
Study type: Observational

The incidence of preterm birth increases annually. Premature delivery has become the leading cause of neonatal illness and death. For the survived premature babies, the incidence of sequelae is also higher than the full-term babies, which brings a heavy burden to a family and society. Preterm birth has become the important factor affecting the quality of births. The occurrence of premature birth is the outcome of combined action of genetic and environmental factors. However, its etiology is not clear. Recent studies have shown that the risk of preterm birth is associated with dietary factors. Choline is an essential nutrient for human health and it plays an important role in the growth and development of fetuses and neonates. The investigators previously found that serum levels of free choline in preterm mothers were lower than those in normal mothers with full-term birth. Serum levels of free choline also reduced in preterms after receiving parenteral nutrition (PN). However, the relationships between choline and preterm birth is not clear. Therefore, this study is aimed to explore the effect of choline intake during pregnancy and genetic polymorphisms on the risk of preterm birth and on the clinical outcomes in preterms receiving total PN therapy. Healthy Chinese pregnant women with their healthy term infants will be recruited as the control group, while Chinese women with preterm delivery and their preterm infants will be recruited as the preterm group. Dietary choline intake during pregnancy will be evaluated by semi-quantitative food frequency questionnaire and 24-h dietary recall questionnaire. Gene polymorphisms in the key enzymes of choline metabolism will be identified among the participated women and neonates through Real-time polymerase chain reaction. Choline and its related metabolites will be assayed using high performance liquid chromatography combined with mass spectrometry among all mothers and preterms before and after 7-days PN treatment. The influence of genetic risk factors and metabolic changes of choline on the physical and mental development of preterms will be evaluated. The results of this study will contribute to a comprehensive understanding of the role of choline and the relative gene polymorphisms on the risk of preterm birth, which will be helpful for estimating the high risk in advance. The results will also provide the scientific evidences to establish the personalized amount of choline intake among women and infants, optimize nutrition support for pregnant women and preterms, and promote better prenatal and postnatal care.

NCT ID: NCT02822027 Recruiting - Preterm Infants Clinical Trials

Intravenous Immunoglobin Transfusion in Preterm Infants With Encephalopathy of Prematurity

Start date: June 1, 2016
Phase: N/A
Study type: Interventional

Infection and inflammation is related to increased encephalopathy of prematurities.

NCT ID: NCT02819570 Recruiting - Clinical trials for Premature Rupture of Membrane

Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis