View clinical trials related to Premature Birth.
Filter by:In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
Bronchopulmonary Dysplasia (BPD) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. These conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury. The study drug, rhCC10, is a recombinant version of natural human CC10 protein. Native CC10 is produced primarily by non-ciliated respiratory epithelial cells, called Clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs. The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (IT) dose of rhCC10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (RDS) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as Chronic Pulmonary Insufficiency of Prematurity (CPIP; asthma, cough, wheezing, multiple respiratory infections). CC10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). Together these properties suggest that administration of rhCC10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to CPIP in these infants. This study is funded by the FDA Office of Orphan Product Development (OOPD).
To date, the investigations in the field of the supplementation with DHA in premature babies have been focused on the study of neuronal and visual development, giving place to contradictory and ambiguous results, because they did not consider in many cases important aspects of this supplementation, such as the mother´s diet, dose, duration, etc., and precise studies have not been performed in the field of the oxidative damage, inflammation and bone development in this population. Hypothesis: If the composition of the mother´s milk is modified on the basis of her diet, a mother supplementation with high doses of DHA will increase proportionally the levels of this fatty acid in her milk, fact that will allows the premature newborn child receive a major dose of this fatty acid, and therefore this way, we will manage to improve the neuronal and visual development and to take part on the inflammatory process, oxidative damage and its evolution, together with the development or bone mass increase in the premature baby. Aims: Overall we aim to evaluate in a multidisciplinary way the effect of a mother supplementation during the lactation with high doses of DHA on the development and wellness of the premature newborn children. We try to deepen into the effect on the neuronal and visual development and to study, for the first time, the effect on the oxidative damage, pro- and antiinflammatory citoquines activity and bone metabolism in this group of newborn babies.
Pharmacokinetics analysis and development of pharmacokinetics model in pregnancy women and fetus
The purpose of this study is to understand if the "DHA gap" can be corrected by giving a daily dose of DHA oil to preterm babies. DHA is an essential omega-3 fatty acid, which means our body cannot make DHA. We have to take it in through our diet. DHA is important for normal brain and eye health and it may also decrease inflammation. This is important for premature babies because they are at a greater risk for getting diseases related to inflammation, especially in their lungs, eyes and intestines. Since DHA is so important for normal growth, you will find DHA naturally in breast milk and it is now added to infant formula. But the amount in breast milk and infant formula is about half of what your infant should expect to get in the womb (about 13-29mg per day in breast milk vs. 50-75mg per day in the womb). Very premature babies are at an even greater disadvantage because they cannot always eat very much right away and that is the only way they can get essential fatty acids in their body. This means premature babies are getting less DHA than they would in the womb and then the "DHA gap" continues for a longer period of time. This gap also comes at a time when their brain is growing most rapidly and their bodies need it the most. This trial is designed to see if giving DHA, even before the baby can take food orally, will raise his/her DHA blood levels to those of normal term babies.
Premature neonates admitted to the neonatal intensive care unit (NICU) require up to several hundred procedures during their hospitalization. Many of these are tissue-damaging procedures (TDPs) that cause pain. Through our NIH funded research, we made the novel observation that exposure to a single TDP can significantly increase ATP utilization and oxidative stress, as evidenced by increased plasma levels of hypoxanthine, uric acid and malondialdehyde in neonates exposed to TDPs as compared to controls (no TDP). Because neonates are exposed to numerous TDPs, it is relevant to explore the energy costs of repeated exposures to painful procedures, an important information that is currently not known, as the effect of this cumulative metabolic dysfunction could result in potentially treatable or preventable cell injury. Oral sucrose analgesia is frequently given to relieve procedural pain in neonates on the basis of its effect on behavioral and physiological pain scores. However, we found, through our prospective, randomized, double blind study funded by NIH, that although oral sucrose significantly reduced pain scores, its administration before a single TDP (heel lance) significantly increased ATP utilization. This is evidenced by higher plasma concentrations of hypoxanthine and uric acid in neonates given sucrose compared to control neonates (no TDP, no sucrose) or neonates just given a pacifier. These novel findings raise concern because preterm neonates have limited ATP stores and are susceptible to cell injury due to ATP depletion. In addition, it raises the relevant concern: If a single dose of oral sucrose can alter ATP metabolism, what are the effects of exposure to multiple doses of oral sucrose? More importantly, what is the effect of multiple TDPs and/or multiple oral sucrose dosages on ATP utilization, oxidative stress and cell injury? This application will also explore the effect of 30% oral glucose, another sweet solution currently used to relieve pain, on ATP metabolism. In this study, we will test the general hypothesis that exposure to multiple TDPs and/or multiple doses of oral sucrose analgesia compared to oral glucose or standard care, alter biochemical markers of ATP utilization, oxidative stress and cell injury. We will use a prospective randomized clinical research design to test this hypothesis during days of life 3-7 of human premature neonates. Increased ATP utilization will be quantified by concentrations of hypoxanthine, xanthine and uric acid measured using HPLC. Oxidative stress will be quantified by concentrations of allantoin using gas chromatography/mass spectroscopy, and cell injury will be quantified through urinary concentration of intestinal fatty acid binding protein, an early marker of enterocyte injury. Data from this application will provide insight into the cellular and biochemical effects of repetitive and accumulated TDPs and/or multiple doses of oral sucrose. With this knowledge, we will propose and test innovative strategies that will not only decrease pain but also will prevent cell injury or cell death.
The proposed feasibility study will evaluate the investigators ability to conduct a clinical trial of a novel intervention (SPEEDI) which addresses a striking gap in the literature. Supporting Play, Exploration, and Early Development Intervention (SPEEDI) differs from current early intervention practices in 2 important ways. First it bridges the traditional gap in services from the Neonatal Intensive Care Unit (NICU) to home providing ongoing and intensive support for developmental activities when parents are establishing care giving routines. Second, in contrast to wide-ranging intervention provided by current early intervention models, SPEEDI uses an action perception model to target specific behaviors which lead to improved early motor abilities and provide a foundation for learning.[6] The purpose of this feasibility study is to extend the investigators preliminary data and evaluate the feasibility of conducting a randomized control trial to evaluate the efficacy of SPEEDI.
This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.
Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).
Docosahexaenoic acid (DHA) has been shown to be particularly important for fetal and neonatal development. Infants born prematurely are at special risk for DHA insufficiency. The source of DHA after birth for preterm babies who are not fed full enterally, are mostly fat emulsions as the component of total parenteral nutrition solutions which usually do not contain DHA. The aim of this study is to investigate if the fish oil emulsion-administered from the first day of life and during parenteral nutrition-prevents infants from cholestasis and retinopathy of prematurity.