View clinical trials related to Premature Birth.
Filter by:Every year, globally, about 15 million babies are born preterm (before 37 weeks). This number is rising. Preterm birth (PTB) complications are the leading cause of death among children under 5 years of age, responsible for nearly 1 million deaths annually. PTB poses a strain on scarce health resources: each very premature baby costs tens of thousands of pounds in newborn care. One in 4 babies born before 28 weeks develop neurological impairment, a parent often having to give up work to care for an affected child. The prediction and prevention of PTB remain challenging because current methods, such as measuring the cervix by ultrasound, have limited accuracy. If a technique that reliably predicts PTB could be developed, there are care measures that can be employed to delay birth to reduce long-term disability/impairment. The Investigators have been studying whether they can detect the changes in cervical tissue structure and composition that precede PTB by using very low current Electrical Impedance Spectroscopy (EIS). Evidence recently showed that women at high risk of PTB (history of previous PTB), who deliver preterm, including delivery before 28 weeks gestation, have lower cervical "resistance" in mid-pregnancy than those who deliver at term. With NIHR funding, the investigators have developed a new device, based on a technique called magnetic impedance spectroscopy (MIS) that should address limitations of the EIS device for assessing PTB risk. The investigators now want to refine the new MIS device by minimising the signals it receives from other tissues around the cervix and making its measurements at internal body temperature more stable. The researchers also conduct clinical experiments to test whether it predicts PTB better than the previous EIS device, and check whether pregnant women find its use acceptable. This information will allow them to obtain UK regulatory approval to test the device in larger trials.
Preterm birth predisposes infants to greater risk for respiratory morbidities and the need for pulmonary care compared to term infants both in the short-term and long-term. In the short-term, preterm birth is a high risk factor for development of bronchopulmonary dysplasia (BPD), the second most common chronic pediatric respiratory disease after asthma. In the long-term, following discharge from the neonatal intensive care unit (NICU) and the hospital, preterm birth carries a high risk for respiratory morbidities (e.g., wheezing, cough, doctor visits, and hospitalizations for respiratory infections) and resource use, which in turn predisposes infants to the development of lung diseases in childhood and adulthood, including airway hyperresponsiveness, asthma, and chronic obstructive pulmonary disease (COPD). There is a significant unmet need for safe and efficacious approaches in the prevention and treatment of respiratory morbidities of prematurity. The study will be conducted in the neonatal intensive care unit (NICU) in preterm infants to determine safety, tolerability and lung delivery performance of RVT-1601, a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer/face mask.
According to the World Health Organization, preterm birth (from 20 to 37 gestation week) is a significant global health problem, as preterm infants represent an estimated 15 million infants per year worldwide. One of the important problems experienced by the preterm infants, leaving their intrauterine environment earlier than normal, while receiving special treatment and care in Neonatal Intensive Care Unit is the painful procedures. Exposure to pain may change preterm infants' brain structure and organization as well as impair brain development through oxygen desaturation, leading to generation of free radicals that can damage fast-growing tissues. For this reason, preterm infants need to be supported and protected more in pain procedures. Orogastric Tube (OGT) is a feeding method that is used to support the nutrition of preterms that cannot be fed orally and causes OGT insertion pain. Although non-pharmacological methods are effective in reducing the pain caused by OGT insertion in preterms, a limited number of studies have been found. There was no study using combined nonpharmacological methods to reduce OGT insertion pain.To evaluate the efficacy of the use of expressed breast milk, swaddling and facilitated tucking methods alone and combination in reducing the pain caused by OGT insertion in preterms. Randomized controlled trial. Three level III neonatal intensive care units in Turkey. Preterm infants born 32-34 weeks of gestation were randomly assigned to six groups: routine care group (n=33), swaddling group (n=30), facilitated tucking (n=32), expressed breast milk (n=31), swaddling+expressed breast milk group (n=30), and facilitated tucking+expressed breast milk group (n=31). OGT insertion included four phases: baseline (the last 1 min of the 30 min without stimuli), OGT insertion, recovery (1 min after OGT insertion), recovery (2 min after OGT insertion). Four phases of OGT insertion procedures were videotaped. Premature infant pain profile (PIPP) score, heart rate, and oxygen saturation were assessed by two independent evaluators who were blinded to the purpose of the study. Data were analyzed by analysis of variance for the multiple repeated measurements, bonferroni, Generalised Estimating Equation logistic regression. 187 preterm infants completed the protocol.
The study will follow a prospective cohort of racially and economically diverse mothers of premature infants for 3 weeks following delivery to test whether antenatal education of the support person of mothers may decrease time to initiation of breast pumping, decrease time to lactogenesis stage II and increase breast milk production.
The purpose of this study is to demonstrate how well aflibercept works in babies with ROP, comparing it with laser therapy. The study also has the objective to demonstrate how safe aflibercept is when used in babies, and describe how the drug moves into, through and out of the body.
Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.
This work is designed to study the effect of the early use of caffeine citrate in preterm neonates who need respiratory support on morbidity and short term neonatal outcome.
The purpose of this study is to test the efficacy of a combination of motivational interventions and a brief therapy session to increase the adherence to medication-assisted treatment (MAT) for opioids.
Preterm birth (PTB) is the primary cause of infant death worldwide. It has been shown that a vaginal microbiota deplete in Lactobacillus species is a risk factor for preterm labour. Conversely a vaginal microbiota dominated by Lactobacillus crispatus appears to be protective for these adverse outcomes. A wide range of 'over the counter' Lactobacillus spp. containing products targeted at 'vaginal health' and formulated for vaginal administration are available, but most of them do not contain vaginal species of Lactobacillus. The primary aim of this study is to determine whether vaginal supplementation with L. crispatus CTV-05 is associated with colonisation.
This single-group study will assess growth and tolerance of infants fed a post-discharge preterm infant formula containing a prebiotic.