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Premature Birth clinical trials

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NCT ID: NCT02601872 Not yet recruiting - Premature Infant Clinical Trials

Erythropoietin in Premature Infants to Prevent Encephalopathy

Start date: November 2015
Phase: Phase 2
Study type: Interventional

The main goal of this trial is to investigate whether early administration of human erythropoietin(EPO) in preterm infants improves neurodevelopmental outcome at 18 months corrected age. This study is designed as randomized, double-masked, placebo controlled multicenter study involving at least 312 patients.

NCT ID: NCT02598323 Not yet recruiting - Premature Labour Clinical Trials

Prevention and Treatment of Premature Labour for Asymptomatic Pregnant Women

Echo-col
Start date: November 2015
Phase: N/A
Study type: Interventional

State of the question and research objective: International trials have shown that ultrasound measurement of the cervix identifies a population at high risk of preterm delivery. In case of short neck several types of treatments can be recommended: progesterone, the establishment of a strapping or pessary. These three treatments reduce the risk of preterm delivery. There is no French study. The objective of this study is to reduce prematurity in the PACA region Monaco-Corsica by introducing a routine ultrasound screening strategy asymptomatic short necks. Population concerned: All patients with active singleton pregnancy between 16 and 26 SA SA are eligible to ultrasound of the cervix. - Primary endpoint: delivery rate before 37 weeks. - Criteria secondary judgments rate of deliveries before 37 weeks, neonatal mortality morbidity. Expected result: a prematurity of 50%

NCT ID: NCT02534090 Not yet recruiting - Clinical trials for Necrotizing Enterocolitis

Evaluation of Feeding Intolerance in Premature Infants Using Near Infrared Spectroscopy

NIRS/NICU2
Start date: November 2015
Phase: N/A
Study type: Observational

Nowadays feeding intolerance (FI) is a common condition among preterm infants. It has been estimated that 16%-29% of premature infants admitted to neonatal intensive care units (NICUs) develop feeding intolerance at some point during their length of stay. The most frequent signs of FI are the presence of abdominal distension, abundant and/or bilious gastric residuals and vomiting suggesting an inability of the infant to further tolerate enteral nutrition, it increases with decreasing in gestational age (GA) and birth weight (BW). FI represents one of the most uncontrollable variables in the early nutritional management of these infants, and may lead to suboptimal nutrition, delayed attainment of full enteral feeding and prolonged parenteral nutrition supply. NIRS has been used in preterm infants to evaluate changes in cerebral perfusion and oxygenation. It provides real time insight into the oxygen delivery, presented as regional oxygen saturation rSO2 with lower values than SpO2 distal pulse-oximetry where is mostly measured as arterialized capillary bed (around 55% vs 98% Oxygen saturation in regional NIRS vs conventional pulse-oximetry). Light easily penetrates the thin tissues of the neonate through bone and soft tissue, particularly the thin capillary bed of the tissues; NIRS provides non-invasive, continuous information on tissue perfusion and oxygen dynamics. This technique uses principles of optical spectrophotometry that make use of the fact that biological material, including the skull, is relatively transparent in the NIR range. Dave et al. evaluated the abdominal tissue oxygenation with NIRS, and showed that preterm infants change their cerebral - splanchnic oxygenation ratios during feedings, mainly because an increasing in the splanchnic oxygenation. Gay et al. performed abdominal NIRS in premature piglets showing association of perfusion/oxygen changes with NEC spectrum. The investigators would like to evaluate the association between feeding intolerance and unchanged splanchnic regional saturation and variation in the cerebral splanchnic ratio. Innovation: FI diagnosis follows a subjective approach, where the clinician is worried in further risk of develop Necrotizing enterocolitis (NEC). This non-studied relationship (FI and NEC) lower the threshold for the diagnosis of FI. Furthermore, infants with FI diagnosis commonly are subject of stop or slow the progression of feedings, increasing the risk of intestinal villi atrophy, and increase the length of parenteral nutrition support, and also the length of stay in the NICU settings. If NIRS technology help the clinicians to detect true abnormalities objectively as a new monitor assessing adequate feeds progress decreasing failure to feed, and therefore diminishing the need for parenteral feeds and further complication associated with it.

NCT ID: NCT02528851 Not yet recruiting - Preterm Infant Clinical Trials

Cardiorespiratory Effects of "Higher" Versus "Equivalent" CPAP Upon Extubation From High EAP in Preterm Infants

CO-PAP
Start date: October 2015
Phase: N/A
Study type: Interventional

The aim of this study is to compare the cardiovascular and respiratory effects of "higher" versus "equivalent" CPAP pressures post-extubation from high endotracheal airway pressures (EAP), defined as at least 8 cm H2O (water), in the form of a randomized controlled cross-over trial. Endotracheal airway pressure (EAP) will be defined as mean airway pressure (MAP) [if on high frequency ventilation] or positive end-expiratory pressure (PEEP) [if on conventional ventilation] at time of extubation. Participants will be randomized to "higher" CPAP group (CPAP level 2cm H2O higher than the extubation EAP) or "equivalent" CPAP group (CPAP level equal to the extubation EAP) before undergoing crossover to the other arm. We hypothesize that "higher" CPAP levels, when compared to "equivalent" CPAP levels, do not adversely impact the cardiorespiratory status when a patient is extubated from high EAP.

NCT ID: NCT02470676 Not yet recruiting - Preterm Birth Clinical Trials

Cervical Pessary vs Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial

Start date: July 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations. All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial. Women who meet eligible criteria will be invited to participate in the clinical trial. Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary). Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.

NCT ID: NCT02304237 Not yet recruiting - Premature Birth Clinical Trials

Vaginal Compared With Intramuscular Progesterone for Prevention of Preterm Birth in High Risk Pregnant Women

Start date: December 2014
Phase: Phase 3
Study type: Interventional

This study is for compare the efficacy of two different regimens(vaginal vs intramuscular) of progesterone therapy in prevention of preterm birth in high risk pregnant women.

NCT ID: NCT02196103 Not yet recruiting - Pregnancy Clinical Trials

Management of Labor in Patients With Previous Cesarian Section

Start date: September 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Induction of labor in women desiring TOLAC has long been a topic of controversy. The paucity of published data on mechanical cervical ripening in the setting of TOLAC and term PROM has led us to undertake the present clinical trial.

NCT ID: NCT02109302 Not yet recruiting - Clinical trials for Premature Ejaculation

Primary Premature Ejaculation Genetics

Start date: n/a
Phase: N/A
Study type: Interventional

The main objective of our study is to identify the first genetic etiology of primary Premature Ejaculation (PE). We will test and evaluate the existence of genetic determinism conferring susceptibility to a life-long syndrome (primary premature ejaculation) in some patients. To this end, we plan to establish a collection of biological samples and a database of patients with this extreme syndrome, which we will analyze by Genome Wide analysis. This will lead to improvements in the biological understanding, the "knowledge" of physicians of the disease, and should improve the patients' quality of life. Not all PE cases have the same physiopathology and treatment efficiency, which depend on the specific mechanism involved in the clinical context. Our work will make it possible to develop new therapeutic approaches suitable for a large proportion of individuals presenting PE. This integrative approach combining researchers, patients and ethics committees will facilitate profound reflection, promoting the creation of suitable structures capable of receiving patients for appropriate consultations. This unique study of PE should also favor industrial partnerships.

NCT ID: NCT02043249 Not yet recruiting - Preterm Delivery Clinical Trials

Cord Milking and Activity Of The Immune System In Preterm Infants

Start date: January 2014
Phase: N/A
Study type: Interventional

In the embry life there is a passage of IgG type, from the mother to tha embryoyo and only in the age of 3-5 month after birth the infant start to develop them by himself. In preterm infants the starting point of the level of the IgG's is lower from the level of term infants. Delayed cord clamping /milking it was prooved in many researches as benificial in terms of : levels of hemoglobin; hematocrit and feritin in the neonats. Also benefits were proved by means of less need for blood tranfusion, less intra ventricular hemorrhage; necrotzing entero colitis and iron deficiency anemia. The hypothesis is that delayed clamping /milking it will increse the level of IgG's in preterm infants. The end point hypothesis is that delayed cord clamping /milking cause to less fever disease or hospitalization it the neonats.

NCT ID: NCT01985594 Not yet recruiting - Preterm Labor Clinical Trials

Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial

UTROGESTAN
Start date: November 2013
Phase: Phase 2
Study type: Interventional

RESEARCH HYPOTHESIS -Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect