Active clinical trials for "Premature Birth"

Preterm delivery (PTD), together with low birthweight (LBW), is the leading cause of infant death and illness, affecting 500,000 births with annual medical costs of more than $26 billion in the U.S. each year. Identifying changeable risk factors to reduce PTD is considered a top research priority. Recent research has shown genital herpes infection (HSV) is associated with increased risks of PTD and LBW. More importantly, treating this infection, including infection with no symptoms, using readily available antiviral medications can be effective in removing the risk due to HSV. Thus, early identification and treatment of HSV in pregnant women could be an effective way to prevent PTD and LBW. Currently, many pregnant women with HSV infection, especially those with no symptoms, choose not to treat due to (a) a lack of demonstrated benefit of treatment and (b) general hesitance to use medications during pregnancy due to safety concerns for the fetus. Thus, emerging evidence of an increased risk of PTD/LBW associated with HSV infection, if untreated, and treatment effectiveness by anti-herpes medications has significantly changed current treatment paradigms among pregnant women. This evidence also provides new hope that effectively treating HSV infection among pregnant women, especially before the 3rd trimester, could lead to a new method to reduce PTD and LBW and reduce racial/ethnic disparities in these risks due to high rates of the infection in minority groups. To further examine the effectiveness of treating HSV in pregnant women to reduce adverse pregnancy outcomes, the investigators propose to conduct a prospective cohort study with a two-stage design combining the large pregnant women population (N=90,000) in Stage I identified through Kaiser Permanente Northern California (KPNC) electronic medical records (EMRs), with a Stage II sample to collect detailed information on additional factors that might muddle our understanding of this issue. This study will address the following: (1) Does treating HSV infection in pregnant women reduce the risk of PTD or LBW? (2) Does timing of the treatment during pregnancy influence treatment effectiveness? (3) Do other factors influence treatment effectiveness? and (4) Does HSV infection in pregnancy, if untreated, increase the risk of PTD and LBW, compared to no infection? Answers to these questions will be valuable to pregnant women and clinicians, and directly address their concerns when making treatment decisions

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

To test the hypothesis that progressive feeding without minimal enteral feeding (MEF) compared to progressive feeding preceded by a 4-day course of MEF will result in an increased number of days alive on full enteral feeding in the first 28 days after birth in extremely preterm infants receiving human milk.

The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.

The investigators will apply xenon-129 (129Xe) and non-contrast enhanced magnetic resonance imaging (MRI) acquisition and analysis methods in 50 subjects aged between 20 and 29 years born pre-term (with and without a diagnosis of bronchopulmonary dysplasia [BPD]) and at term to characterize and probe the relationship between lung structure and function using imaging.

The purpose of this study is to examine whether the value of vaginal fluid cytokine levels as well as computerized fetal ECG analysis are suitable clinical parameters to detect an imminent intra-amniotic inflammation with a high risk of fetal inflammatory response syndrome (FIRS) or a neonatal early onset sepsis (EOS) and whether these parameters can be determined on a daily basis in the clinical monitoring of pregnancies complicated by PPROM.

The study entitled 'Effect of maternal hemoglobin on neurobehavioral development of late preterm neonates' was done with an objective to determine whether low maternal hemoglobin (<11gm/dl), in late preterm neonates(>34weeks but less than 37weeks gestational age) correlates with poor neurobehavioral outcome using the Neurobehavioral Assessment of Preterm Infants(NAPI) tool, thereby allowing for earlier rehabilitative intervention to be undertaken to improve their long term outcomes and to generate useful data on a previously well recognised but under researched entity.

Determine if the stool or vaginal microbiome and urinary metabolite profiles in a pregnant obese population of African American women differ from their pregnant non-obese counterparts Determine if the stool or vaginal microbiome and urinary metabolite profiles vary by class of obesity and magnitude of excess weight gain in this population of pregnant African-American women. Assess the ability of the stool, vaginal microbiome, or metabolites, or the combination of all biomarkers as predictors of preterm birth (PTB) and onset of labor. Determine if any dietary or clinical variables are correlated with changes in the microbiome or urinary metabolites or modify their association with PTB

This study will provide information on the pharmacokinetics, safety and effectiveness of off--label drugs used in critically ill premature infants: doxapram, fentanyl, midazolam, paracetamol, phenobarbital, sildenafil, levetiracetam, ibuprofen and fluconazole. PK/PD analysis with NONMEM (non-linear mixed effects modelling) will result in (adapted) dosage guidelines, thus contributing towards an improvement in the quality of care and cost efficiency. Furthermore the development of Dried Blood Spot (DBS) analysis is investigated for these drugs as a minimally invasive method for conventional patient care and to perform pharmacological studies in children. The adapted dosage guidelines will be implemented directly into clinical practice in collaboration with the NKFK. Therefore the study is designed as an observational multicenter study to be able to collect sufficient data for the drugs of interest.

The purpose of the study is to collect information regarding the safety of dapoxetine hydrochloride when used in clinical practice to treat men with premature ejaculation. Dapoxetine hydrochloride is a selective inhibitor of serotonin reuptake that is indicated for the treatment of patients with premature ejaculation.