Active clinical trials for "Premature Birth"

The overall objective of the proposal is to evaluate the ability of ultrasound to predict the body composition of toddlers in the outpatient clinical setting and to evaluate the relationship between body composition and neurodevelopment.

Newborns admitted to an intensive care unit often require artificial ventilation. For that purpose an endotracheal tube needs to be placed into the trachea, a procedure named endotracheal intubation. The newborns need to be sedated to keep them comfortable, to stop moving and to relax in order to enable the success of the procedure. For this sedation an anesthetic agent named propofol is often used. The used dose of propofol has not been properly studied and as a consequence patients are under- or over -sedated and propofol leads to side effects such as hypotension. The current study aims to find the most appropriate dose of propofol for newborns of different gestational ages and of different post-natal ages. We will use propofol in different doses and after each 5 included patients per age group we will analyze whether the dose needs to be increased or decreased. The effect of the propofol will be extensively monitored and we will study the level of sedation, the quality of intubation, the stability of the patient en the occurrence of side effects. At the end we aim to have appropriate guidelines for propofol doses in newborns of all ages.

The Early Prediction Study is a longitudinal population-based cohort study for very preterm infants ≤32 weeks gestational age. Preterm infants recruited from three greater Cincinnati and two Dayton area neonatal intensive care units (NICUs) will undergo advanced MRIs at 41 weeks postmenstrual age and neurodevelopmental testing at the corrected ages of two and three years correct age. The goal of the Early Prediction Study is to accurately predict motor, cognitive, and behavioral deficits in individual very preterm infants using neuroimaging technologies and established epidemiologic approaches.

This will be a randomized prospective and open-label study with no placebo control or blinding of the participants and the research team members. The study is to compare the effectiveness of vaginal progesterone versus combination of vaginal progesterone and Arabin cervical pessary in the prevention of preterm delivery among patients with incidental shortened cervical length. As part of standard clinical care, all pregnant patients usually have cervical length measurements at the mid-trimester during the anatomy scan from 18 to 24 weeks with the GE ultrasound Volusion 8 using the vaginal probe. Patients with short cervix will be counseled and offered the opportunity to participate in the study. All participants will be taught how to use the vaginal progesterone once daily prior to bedtime. In addition, those in the combination group will have the cervical pessary placed in the clinic right away or within a week if they request for more time to brood over their diagnosis and weigh on the option of inserting Arabin pessary. All participants will be followed up in the high-risk obstetric clinic as per standard prenatal care. Frequency of follow up visits will be individualized depending on patient's need and comorbidities. , Participants will be requested to bring the remnant of the vaginal progesterone to the clinic to assess compliance. Participants in the study will continue their prenatal care with UIC high-risk obstetric clinic until delivery. The study recruitment will occur for a period of 2 years starting from November 2016 to October 2018 or until all the anticipated numbers of study subjects have been attained. There will be 10 % over-sampling to cater for those who will drop out from the study or loss to follow up after randomization, and those who delivered in another hospital. Participants will have access to one of the investigators or the high- risk clinic nurse for any complaints related to their conditions. Participants can opt out at any stage of the study if they do not want to continue further or if there are any adverse effects.

Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better. Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best. Studies of automated control have shown that infants spend more time within their intended target oxygen saturation range. These have not included measurements of transcutaneous oxygen. There are no previous studies directly comparing automated respiratory devices. The investigators aim to show the transcutaneous oxygen levels as well as the oxygen saturation levels when babies have their oxygen adjusted using two automated (servo) control devices delivering nasal high flow. For a period of 12 hours each baby will have their oxygen adjusted automatically using each devices for 6 hours respectively. The investigators will compare the range of oxygen levels that are seen between the two respiratory devices.

Bronchopulmonary dysplasia of premature infants is a common respiratory disease in premature infants. Long-term complications such as recurrent respiratory infection and abnormal lung function may occur in the survivors, and may increase the risk of dysplasia of the nervous system. In the past 30 years, although the monitoring and treatment technology of premature infants has been significantly improved, the incidence of BPD still shows no downward trend, and effective treatment and prevention methods for BPD are still lacking. The progress of clinical research on BPD is slow, one of the important reasons is that the definition of BPD is still not consistent, and its diagnostic and grading standards lack objectivity. To summarize the development of diagnostic criteria for BPD in the past 30 years, there are still the following disadvantages. 1. 2. In the above study, all proposed alternative BPD classification standards did not completely separate HFNC and NIV. In view of this, this study separated HFNC and other NIV to form a new revised BPD classification standard. On this basis, a nested case-control study was conducted to compare the differences between the newly proposed classification standards and NICHD standards in 2001, Rosemary standards in 2018 and Jensen standards in predicting long-term respiratory outcomes and other systemic complications in premature infants, so as to provide a standard for more accurate diagnosis and evaluation of BPD in premature infants.

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

The study will evaluate the effect of oral formulation of insulin on preterm infants, born between 26-33 weeks of pregnancy, weighing over 750 grams, who meet the inclusion and exclusion criteria established in this protocol.

Patent ductus arteriosus (PDA) is one of the most common complications in premature infants. Successful pharmacological closure of PDA with indomethacin was first reported in 1976. Since then indomethacin treatment has become the standard or prophylactic treatment for clinically significant PDA in premature infants. Clinically there is a high incidence of complications associated with indomethacin treatment, including hypoglycemia, necrotizing enterocolitis, GI bleeding, extension of IVH. More recently, ibuprofen has been shown to be effective for the closure of patent ductus arteriosus in premature infants without reducing mesenteric, renal, or cerebral blood flow.Ibuprofen has been shown to close the ductus in animals without reducing cerebral,intestinal or renal blood flow. Furthermore, ibuprofen enhanced cerebral blood-flow autoregulation and had some neuroprotective effect. In recent years, our strategy of PDA treatment for ELBW infants was essentially early targeted indomethacine treatment depending on echocardiographic shunt flow pattern of PDA. (Arch Dis Child 1997;77:F36-F40. Acta Paediatr Tw 1998;39:33-7. and Arch Dis Child 1999;79: F197-F200.) By this regimen, infants will be eligible for the study if their birth weight less than 1000 gm and if they had PDA without other structured cardiac anomaly confirmed by echocardiography shortly after birth (as close as possible to12 hours). After parental informed consent is obtained, infants will be randomly assigned to two groups based on a double-blined design. INDO group will receive echocardiographic assessment at interval of 12-24 hours or clinically necessary, and if the PDA had pulsatile or growing flow pattern, indomethacin is given; if the PDA had flow patterns other than growing or pulsatile pattern, no treatment is given. The subsequent dose of indomethacin is according to the echocardiographic flow patterns at interval of 24 hours from the last dose. When indomethacin was fail to close after the first course, the second course of another 3 doses of indomethacin or ibuprofen will be given. In spite of infants of INDO group or IBUO group, if PDA fail to close after 2 courses of treatment, surgical ligation of PDA would be considered according to the infant's clinical condition. Our historical data showed that the incidence of complication was about 30%. Permitting 5% chance of type I error and 20% of type II error and an absolute reduction of the incidence by 20%, 30 infants in each group is needed to detect a difference. Primary outcome of the assessment is the closure rate of PDA and the incidence of death or pulmonary hemorrhage. Secondary outcome is IVH or PVL, NEC, oliguria and CLD. We expect that, by using this treatment regimen, a high PDA closure rate can be achieved and the survival of very premature infants may be increased.

To evaluate the treatment efficacy and safety usig extended release nifedipine, as maintenance therapy to pregnant women who were hospitalized and treated for preterm labor until 34 weeks' gestation. After the PTL will stop, we will randomize these women for the treatment group and the control (no treatment) group. The main outcome will be preterm delivery before 34 weeks' gestation. the secondary outcome will be the side effects of the medication and the newborn/mother health variables.