Active clinical trials for "Premature Birth"

The goal of the SENSITACT system is to activate an adaptive kinesthetic stimulation to treat apnea-bradycardia events on preterm infants, while minimizing deleterious effects, in particular arousals that can be due either to respiratory efforts or to kinesthetic stimulation itself. This novel system will provide an alternative treatment to apnea-bradycardia, with improved patient comfort and autonomy. In particular, it may become a complementary solution for the current treatments (Manual stimulation by caregivers, continuous or intermittent nasal positive pressure ventilation and methylxanthine therapies) that do not appear to be optimal and usually only allow a partial reduction in the number and severity of apneas.

This is a multicenter randomized study designed to determine if ultrasound indicated cerclage reduces the incidence of spontaneous preterm birth <34 weeks in asymptomatic women with twin gestations and cervical length ≤15mm, diagnosed by transvaginal ultrasound between 16 to 23 6/7 weeks of gestation.

The goal of this randomized clinical trial is to assess sulfasalazine as a potential treatment to prevent recurrent preterm birth. The main questions it aims to answer are: Does sulfasalazine down regulate corticotropin releasing hormone (CRH) levels in pregnant persons with a prior history of preterm birth? Does sulfasalazine reduce the incidence of recurrent preterm birth in pregnant persons given drug vs. controls? Consenting participants will be randomized to receive sulfasalazine or to a control group and will undergo serial blood draws to assess plasma CRH levels.

This study aimed to evaluate the efficacy and safety of applying 5% lidocaine cream to the sensitive area of the glans penis after its precise localization under the penile biological vibration threshold test for the treatment of primary premature ejaculation.

Cerclage placement is known to be beneficial in prevention of preterm birth when placed inn a certain subset of patients. Clinically, the number of sutures can also vary by surgeon preference to one or two sutures in one procedure. This is often decided in the operating room (OR) on the day of surgery but is poorly studied in the efficacy of maintaining the closed cervical length. Retrospective data found no significant benefit on placing two stitches instead of one in preterm birth rate but was extremely limited and heterogenous in many clinical characteristic among the cerclage procedures. There were suggestions that two cerclage sutures may reduce the risk of cerclage revision, birth before 20 weeks, and a nonsignificant improvement in outcome of early preterm deliveries. Therefore, two randomized controlled trials, one prospective study and one meta-analysis were performed. They did suggest a beneficial effect of double cerclage on obstetrical outcomes especially in earlier preterm birth rates although all were limited in sample size and therefore power. A randomized control trial with adequate sample size is still needed to answer the question of whether double cervical cerclage suture is more beneficial than a single suture. Therefore, we propose conducting a randomized control trial between a single or double suture in prophylactic and ultrasound indicated cerclage procedures.

Preterm infants are at risk of developing ROP (retinopathy of prematurity), an eye condition that can cause blindness. Preterm infants born before gestation week (GA) 30 are therefor screened regularly with eye examinations. These eye examinations are painful and despite a lot of research no clear method of pain relief have been found. Since pain in the preterm infant can lead to both short- and longterm negative consequences an effective pain relief during these examinations are of importance. In this study we will investigate if Clonidine can be effective as pain-relief during ROP eye examinations.

This randomized control trial is designed to explore the effect of low-level tragus stimulation in patients with frequent premature ventricular contractions.

Type 1 retinopathy of prematurity in zone I represents the most severe type of ROP and has the worst prognosis. It is unknown whether low-dose bevacizumab will be successful in these severe cases. Also unknown is the timing and extent of peripheral retinal vascularization after low-dose bevacizumab compared with the standard dose. The current study will evaluate whether doses of 0.063 mg and 0.25mg are effective as treatment for type 1 ROP, with ROP and retinal vessels all in zone I.

Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.

Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency (POI) Trial objectives and purpose: To study if rituximab therapy can improve ovarian response to gonadotropin stimulation and menstrual function in women with autoimmune POI. Treatment: Controlled ovarian hyperstimulation before and four months after an infusion of 1-gram rituximab (Mabthera®) twice with two weeks interval. Follow-up period 12 months after infusion. Primary outcome: Number of antral follicles and the size of the largest follicle in response to ovarian stimulation. Secondary outcomes: Reestablishment of spontaneous menstrual bleedings during the 12 months' study period Ovulation during the 12 months' study period Change in B-cell count, autoantibody indices and immunoglobulin levels (IgG) after treatment Safety outcomes: All adverse events. Of particular relevance are any hospital admissions, infections and allergic reactions. Study population: Fifteen women with autoimmune POI defined as absence of menstruation > 6 months and elevated serum level of follicle stimulation hormone > 40 International units (IU)/L. Inclusion criteria: Autoimmune POI defined as presence of autoantibodies against 21-hydroxylase (OH), side chain cleavage enzyme (SCC), 17-OH and/or neuronal apoptosis inhibitory protein (NACHT) leucine-rich-repeat protein 5 (NALP5) or other relevant autoantibodies; 18-35 yrs of age; body mass index 19-30. Exclusion criteria: Hypersensitivity to rituximab; severe infection; severe immunosuppression; cardiac disease; cancer; benign tumours of the hypothalamus, pituitary, or ovary; ovarian enlargement or ovarian cyst; vaginal bleeding of unknown aetiology. Time plan: The study is expected to start the spring 2017. It is expected to be closed spring 2023.