View clinical trials related to Premature Birth.
Filter by:Extremely low birth weight (ELBW), birth weight less than or equal to 1000 g, infants are at high risk for developing brain injury in the first week of life. Intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL) are the most common injuries in this group of infants. Their incidence is inversely proportional to gestational age (GA) and birth weight (BW). These lesions are associated with neurodevelopmental delay, poor cognitive performance, visual and hearing impairment, epilepsy, and cerebral palsy; and instability of systemic hemodynamics during transition from intra- to extra-uterine life and during the early neonatal period is believed to be at their genesis. While the incidence of ultrasound- diagnosed cystic PVL has decreased dramatically over the last 2 decades, diffuse PVL detected by magnetic resonance imaging (MRI) is still prevalent in survivors of neonatal intensive care. Moreover, PVL, even when non-cystic, is associated with decreased cortical complexity and brain volume and eventual neurocognitive impairment. Currently, clinicians lack the tools to detect changes in cerebral perfusion prior to irreversible injury. Unfortunately, the incidence of brain injury in ELBW infants has remained relatively stable. Once translated to the bedside, the goal of this research is to develop a monitoring system that will allow researchers to identify infants most at risk for IVH and PVL and in the future, intervention studies will be initiated to use the changes in cerebral perfusion to direct hemodynamic management. The purpose of this study is to first understand the physiology of brain injury and then to eventually impact the outcomes in this high-risk group of infants by assessing the ability of the diastolic closing margin (DCM), a non-invasive estimate of brain perfusion pressure, to predict hemorrhagic and ischemic brain injury in ELBW infants. The information collected for this study will help develop algorithms or monitoring plans that will maintain the appropriate brain perfusion pressure and thereby, prevent severe brain injury.
In a hospital environment, initial parenting of a family with a preterm neonate will be very different than expected. This unusual and stressful situation may determine the self-confidence perceived by mothers and fathers in caring their baby and therefore could shape future interaction with him/her as well as neurodevelopmental and behavioral development of preterm infants. 24/7 neonatal units allow parents stay with their baby whenever they want but this free access nor guarantee neither encourage parenting self-efficacy if it isn`t hand in hand with a specific training program for parents.
Particular attention is paid to thermal management of preterm neonates in neonatal intensive care units because of the major risk of morbidity associated with hypothermia. Percutaneous central venous catheter placement is essential to ensure adequate caloric intake and intravenous administration of treatments, but this procedure can cause major body temperature variations, responsible for complications in these neonates, as convection incubator function is impaired during opening of the incubator, which can be prolonged (30 minutes to 2 hours) depending on the technical difficulties encountered during catheter placement. In parallel, the use of a polyethylene bag or sheet in the delivery room and for neonatal transport is now clearly defined and ensures stability or even a considerable temperature gain during transfer immediately after birth. In the light of several clinical cases, the use of a polyethylene bag during central venous catheter placement appears to be effective to prevent body temperature loss in preterm neonates. No data are currently available concerning the value of this method of prevention of hypothermia during this type of procedure. Preliminary studies conducted by our team on a dummy suggest that a polyethylene bag or sheet could be useful during this procedure by significantly reducing heat loss caused by convection and evaporation. However, compensation phenomena such as generalized vasoconstriction to cold in preterm infants are very poorly described, but can induce a functional conflict between mechanisms ensuring maintenance of homeostasis and those involved in maintenance of blood pressure.
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.
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.
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.
Spontaneous preterm birth (SPTB) remains the number one cause of perinatal mortality in many countries, including the United States. Multiple gestations are at increased risk of SPTB. A short cervical length (CL) on transvaginal ultrasound (TVU) has been shown to be a good predictor of SPTB, in both singletons and twins. The cervical pessary is a silicone device that has been used to prevent SPTB. The efficacy of the cervical pessary has been assessed in several populations including singletons with short CL, unselected twins, twins with short CL, and triplet pregnancies. Several randomized clinical trials (RCTs) have been published, and several are ongoing. However, no consensus on use of the cervical pessary in pregnancy or guidelines for management have been assessed.
This study evaluates the perinatal factors influencing body composition at discharge in very preterm infants and the relationship between fat free mass and further neurocognitive development.
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
In this project, the investigators will study a cohort of preterm infants, together with their parents, during NICU hospitalization and follow their developmental trajectory until the age of two. An important first scientific goal of the project is to identify objective stress markers that can be obtained easily and non-invasively in preterm infants during NICU hospitalization. This will include the development of novel techniques to measure stress related heart rate variability (HRV) and EEG maturation, as well as sleep stage markers for preterm infants. Secondly, the investigators will study the emotional and bonding processes in parents of preterm infants. Parental distress in terms of depressive symptoms, anxiety, perceived stress and parent-infant bonding will be measured at multiple measuring points. This will enable the validation of psychometric instruments in the specific population of parents of preterm infants. Also, the investigators can investigate the effect and predictive value of the course of parental depression, anxiety and stress scores on child's developmental outcome and on parent-infant bonding and attachment. Thirdly, studies on epigenetic changes due to prenatal stress are still scarce in humans. In this study, the investigators will include a cohort of mothers experiencing profound prenatal stress due to preterm labor, which will complement the earlier work that has been carried out in a low-risk population. The investigators expect more profound changes in methylation state of the NR3C1 and other promotor regions in their cohort of mothers exposed to important prenatal stress. Secondly, the methylation of oxytocin receptor regions will be studied in relation to attachment and bonding. An important overall goal of the project is to develop a Perinatal Stress Calculator that studies the value of the different neonatal, endocrinological, psychological and physiological stress-related parameters to predict differences in psychomotor, cognitive, behavioral, and emotional development. This longitudinal study design will enable the investigators to use the perinatal stress calculator to study the relation between the perinatal stress parameters and later developmental disabilities such as motor impairment, cognitive deficits, language delay but also social and behavioral problems such as attentional deficits and emotional self-regulation dysfunction.