View clinical trials related to Premature Birth.
Filter by:Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator. Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control. The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France). The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.
Most fatty acids, important for development and especially the Omega-3 fatty acids for the brain development are transferred in the third trimester with means that in the premature infant this transport via the placenta is interrupted and the infant is dependent on the concentrations in breast milk which vary depending on the mother's diet and her stores. It has even been suggested that low Omega-3 would be a cause of premature delivery. Many countries have much higher levels of Omega-3 fatty acids in breast milk than found in Sweden and breast milk substitutions are generally now supplemented with the Long Chained Poly Unsaturated Fatty Acids (LCPUFA). Therefore the supplementation to be given can not be seen to give any risks for the infant. On the contrary, several studies have shown that mother who eat equal to or less than twice fish a week during pregnancy give birth to infants with impaired development. Low Omega-3 levels in premature infants between gestational ages of 23 and 40 weeks can be one reason for Retinopathy of Prematurity (ROP) development. Restoration of Omega-3, Dokosahexaenacid (DHA) and Eikosapentaenacid (EPA) to normal in utero levels may prevent ROP by allowing normal vessel growth and survival. An increase of Omega-3 levels bringing levels to within physiological range may prevent development of ROP.
Premature ovarian insufficiency (POI) is a life-changing condition that affects women in their reproductive age. There is a lack of reports which focus on how to improve the reproductive outcome of these women who wish to conceive spontaneously or use assisted conception with their own oocytes. However, one could surmise that it is important to lower gonadotropin levels into the physiological range before embarking on any treatment, even if natural conception is the only choice for the woman/couple.
The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations on blood arginine levels and the genes that are involved in body nutrition and fighting infection in premature babies. They will also investigate the effect of supplementing arginine on these genes. The investigators will undertake a single centre exploratory physiological study in 12 very premature infants receiving PN. 4 of these infants will be supplemented with arginine. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 10 days of life. They will take blood for analysis at prespecified intervals for microarray, ammonia and IGF-1 levels. Microarray findings will allow the investigators to describe the effect of arginine on gene activity in preterm infants.
This study will evaluate the accuracy of both an electronic stethoscope and electrocardiogram (ECG) to evaluate heart rate in neonatal patients in the delivery suite. The initial phase of this study will assess the electronic stethoscope use on stable neonates on the neonatal care prior to use in the delivery room.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. In singleton gestations a short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB. Different strategies have been adopted for prevention of SPTB. Growing interest has focused on pessary for prevention of SPTB. Cervical pessary is relatively non-invasive, easy to use, does not require anesthesia, can be used in an outpatient clinic setting, and it is easily removed when necessary. However, a recent systematic review and meta-analysis of randomized clinical trials showed that in singleton pregnancies with short cervix, prophylactic use of the pessary did not reduce the rate of spontaneous preterm delivery or improve perinatal outcome. 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 women with both prior SPTB and TVU CL ≤25mm. Interestingly, only 235 singletons without prior SPTB,7 and 504 singletons gestations with prior SPTB,6 have been included in randomized studies on cerclage for TVU CL ≤25mm. A meta-analysis of four trials showed that cervical cerclage did not prevent SPTB in women with short TVU CL and without prior preterm birth.7 However, even if the statistical significance were not reached, they found a reduction in SPTB <35 weeks by 16% in singletons with short TVU CL and without prior SPTB (20.6% vs 31.2%; relative risk (RR) 0.84, 95% confidence interval (CI) 0.60 to 1.17) and by 24% in singletons without risk factors for SPTB (25.6% vs 33.3%; RR 0.76, 95% CI 0.52 to 1.15). Therefore, the aim of this study is to evaluate the efficacy of cervical cerclage in prevention of SPTB in singleton pregnancies with short TVU CL in second trimester, without prior SPTB.
Inadequate maternal nutrition is likely to undermine the potential impact of infant and young child feeding (IYCF) improvements made in the Alive & Thrive (A&T) first phase because it is linked to poor fetal growth leading to small-for-gestational age and pre-term newborns. These babies do not respond to growth promoting feeding practices as well as normal newborns do. In Phase 2, Alive & Thrive decided to focus on integrating a package of maternal nutrition interventions in a large-scale maternal, newborn and child health program (MNCH). This proposed evaluation aims to assess the feasibility of integrating maternal nutrition interventions into an existing MNCH platform in Bangladesh, using a cluster-randomized evaluation design.
The Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.
The purpose of this study is to determine whether iron-fortified PN is effective in the preventative and treatment of preterm infants. Preterm infants are at risk for anemia especially in preterm infants. Anemia effects growing development, clinical prognosis, cognition, movement, learning ability and behavioral development. As enteral nutrition is not feasible soon after birth in most preterm infants, parenteral iron administration is an efficacious method for investigators to select. For most preterm infants, the use of parenteral nutrition(PN) is very common during the first ten days of life, so the investigators hypothesis that iron-fortified PN may have a preventative and treatment effect on preterm infants using PN as a supplementation of oral nutrition; Iron-fortified PN can also improve iron store status of preterm infants. The higher concentration of iron used in this study, the larger preventative or treatment effect on preterm infants anemia; it is safe to add small dose of iron agent to PN.
This prospective non-intervention cohort study will enroll women in the first or early second trimester of pregnancy and follow them through delivery (or end of pregnancy) and 1 year postpartum. Infants will also be followed until 1 year postpartum. Detailed medical and obstetrical information will be collected, as well as biological samples, in order to better elucidate the biological mechanisms leading to preterm delivery among Zambian women, in an effort to identify new strategies for prevention.