Active clinical trials for "Premature Birth"

Study Design: Single Blind Placebo Controlled Randomized Trial, aiming to assess the efficacy and safety of adding sildinafile 50 mg to dapoxitine 30 mg in dapoxitine non responding premature ejaculation.

Premature ovarian insufficiency (POI) seriously affects the physical and mental health of women. Nowadays, Chinese herbs have huge appeal and potential in treating POI. We have created a new Chinese herbal combination TJAOA101, whereas its safety and efficacy still need to be validated. Hence, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of POI. We aim to provide a solid evidence for TCM in therapy of POI.

The aim of this prospective observational study (pilot study) is to test if synchronized noninvasive positive pressure ventilation (S-NIPPV) is feasible and works appropriately during transition from intrauterine to extrauterine life in very preterm infants in the delivery room.

Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.

achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.

The goal of this research project is to identify the long-term outcome of neurodevelopment in patients with retinopathy of prematurity(ROP) and the treatment of anti-vascular endothelial growth factor (VEGF) such as intravitreal injection of bevacizumab (IVB), ranibizumab, or aflibercept.Investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. Studies in both animalsand humans have found evidence of systemic bevacizumab exposure after IVB. In an animal study, IVB at an early age could result in more systemic bevacizumab exposure. Our study has further shown that VEGF levels in ROP infants were depressed for 8 weeks after IVB. VEGF plays an important role in neurogenesis in embryos and preterm newborns. In previous reports, blocking VEGF-A expression has been shown to impair brain vascularization and lead to neuron apoptosis in the retina. In addition, VEGF has been found to be lower in preterm pups compared to term pups, and this has been proposed to relate to the neurodevelopmental delay and reduced growth of the cerebral cortex in premature infants. Since neurogenesis may continue in the third trimester, further inhibition of serum VEGF in preterm newborns may have long-term effects on the development of the central nervous system and other systems. Currently, most studies reported neurodevelopmental outcomes in anti-VEGF treated premature infants before 2 years of age, and only one study reported 5 year outcomes. Our recent study also found that the neurodevelopmental outcomes at the mean age of 1.52 ± 0.59 years after birth were similar between ROP patients who did not require treatment and ROP patients with IVB treatment. Unfortunately, the value of early assessments of cognition in predicting cognitive functioning at school age and older is questionable.Many developmental deficits in cognition, emotional and behavioral development, and social adaptive functioning may emerge at older ages in the absence of neurodevelopmental impairment in toddlerhood. Visuomotor function deficit are also noted at school age in children who had normal development at 3 years of age. The above studies demonstrate a need for longer follow-up of the preterm infants to fully comprehend their neurodevelopmental outcomes. To our knowledge, currently there are no reports of neurodevelopmental outcomes in anti-VEGF treated premature infants beyond 5 years of age. Therefore, investigators propose this study hopefully to have a better understanding of the long-term safety of anti-VEGF on the treatment of ROP. This study will aim at (1) Understanding the long-term neurodevelopmental outcomes of intravitreal injection of anti-VEGF comparing to standard laser treatment for ROP in premature infants. (2) Compare the long-term neurodevelopmental outcomes in premature infants with ROP treated by different anti-VEGF agents. (3) Analysis the long-term ocular morphological and functional outcomes in premature infants with ROP with prior treatments. Investigators plan to recruit patients from our previous ROP cohort, who now aged 3 to12-years-old. Thepatients will be divided to six groups:premature without ROP (Group 0); ROP without treatment (Group 1); ROP with laser photocoagulation treatment (Group 2); ROP with anti-VEGF treatment (Group 3); ROP with laser photocoagulation + anti-VEGF treatment (Group 4); Fullterm (Group 5).Serialneurodevelopmental tests, such as Chinese Child Development Inventory (CCDI), Child Behavior Checklist (CBCL), The Berry-Buktenica Developmental Test of Visual-Motor Integration, Bayley Scales of Infant Development, Wechsler children's intelligence test- fourth editionand other neurocognitive tests and questionnaires, will be performed yearly in all patients. The detailed visual tests, such as best-corrected visual acuity, slit lamp examination, indirect ophthalmoscopy,and optical coherence tomography (OCT) will be performed every 6 months. Main outcome measures will be neurodevelopmental outcomes. The neurodevelopmental outcomes will be analyzed longitudinally and in the cross-section fashion. These outcomes will be compared between the five groups, and in the subgroup analysis. Secondary outcomes will include ocular morphological and functional results of these children. Finally, the correlation of ocular resultswith neurodevelopment outcomes will be analyzed. Investigators are fortunate to have the opportunity of following a longitudinal ROP cohort and monitor their long-term outcomes. In the long-term, this studywill improve understanding the long-term safety of anti-VEGF treatment for ROP, which is a heatedly debated topic. Investigators will also have a better knowledge which anti-VEGF might be safer than the other. Understanding these facts will help us to come up with a better treatment strategy for ROP in the future.

Objective: This trial is designed to compare between the effectiveness of nifedipine versus magnesium sulfate (MgSO4) for tocolysis in women with threatened preterm labor. Patient Population: The population will include pregnant women at gestational age between 32 and 36 weeks who are 18 years old or older and have signs of threatened preterm labor. Study Design: This is a single-center, prospective, randomized controlled clinical trial. A total of 264 women pregnant between 32 and 36 weeks having threatened preterm labor will be enrolled and randomized into two parallel treatment arms. Patients in the group A will receive nifedipine, while patients in group B will MgSO4 only. Treatment: All patients will be randomized on the day of enrollment. Patients with threatened preterm labor will receive the respective tocolysis in each group. All patients will receive corticosteroids for lung maturity according to the local protocol. Primary outcome: Number of women not delivered within 48 hours of starting tocolytic therapy. Secondary outcomes: perinatal mortality, a composite of adverse neonatal outcomes, birth weight, days on ventilation support, length of admission in neonatal intensive care, prolongation of pregnancy more than 7 days, delivery after 37 weeks of gestation, number of days till delivery, maternal mortality, maternal infection, and harm to mother from intervention.

The goal of this clinical trial is to study the effect of twice-daily saline enema (SE) in the treatment obstruction of prematurity (MOP) in infants with the birth weight ≤1.25kg. The main questions, the trial aims to answer are To validate the finding of our pilot study which had shown that twice-daily SE reduces the time to reach full enteral feeds in premature infant as compared to premature infant treated with Glycerine Suppository (GS), in a larger cohort. Infant with MOP fails to pass meconium in the first 48 hours of life and develop symptoms and signs like abdominal distension and feed intolerance. The other aims of this study are to test whether the intervention is Effective treatment for MOP Reduce the duration of ICU stay Reduce the rate of necrotizing enterocolitis, sepsis, Total Parenteral Nutrition (TPN) days and number of intravenous catheter days The study also wants to explore the impact of this intervention on the gut microbiome, gut-brain interaction and immune response of the new-born.

The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome. The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.

Early hemodynamic effects (within 3 hours of life) of Delayed Cord Clamping compared to Umbilical Cord Milking are still unknown. Four sites experienced in the use of NIRS and who have appropriate data collection equipment in the delivery room (Alberta, Ulm, Cork and San Diego) will obtain and report the physiological changes with UCM and DCC from birth until 24 hours of life. This data will yield the largest available sample of continuously recorded heart rate, cerebral tissue oxygenation, peripheral oxygen saturation, airway pressure, and administered FiO2 to delineate the short term responses to two methods of placental transfusion. In our initial trial we demonstrated increased blood pressure from 3-15 HOL with UCM compared to DCC in premature newborns <32 weeks, but did not show any differences in cerebral oxygenation.