View clinical trials related to Premature Infants.
Filter by:Background: fluctuation of cerebral blood flow and oxygenation in neonates who undergo intensive care is an important risk factor for risk of neurodevelopmental impairment. Near infrared spectroscopy (NIRS) allow direct measurements of cerebral tissue oxygenation. Automated Fraction of Inspired Oxygen (FiO2) adjustment can maintain arterial oxygen saturation (SpO2) within a target range and may reduce risk of fluctuation of cerebral oxygenation. Aim of this study: to evaluate the efficacy of automated FiO2 adjustment in maintaining SpO2 within a target range and in reducing the risk of cerebral tissue hypo-oxygenation due to SpO2 fluctuations in preterm infants on invasive or non invasive respiratory support with supplemental oxygen.
Honey is a natural product that contains multiple nutrients; it is composed of fructose, glucose and fructooligosaccharides that can potentially serve prebiotic functions. It also contains more than 180 substances including amino acids, vitamins, minerals and enzymes. Investigators hypothesized that supplementation of enteral feeds with honey would produce a bifidogenic effect and stimulate the immune response in preterm infants. Investigators randomly assigned subjects to 4 groups receiving 0, 5, 10 and 15 grams of honey daily for 2 weeks and measured their effect on stool colonization, systemic immune parameters and anthropometric measurements.
This study uses frequency domain near-infrared spectroscopy coupled with diffuse correlation spectroscopy (FDNIRS-DCS) technology for monitoring cerebral blood flow (CBF) and cerebral oxygen metabolism (CMRO2) at the bedside for newborns with germinal matrix-intraventricular hemorrhage (GM-IVH) and/or post-hemorrhagic hydrocephalus (PHH) in comparison to newborns with hydrocephalus of a different etiology (VC) and healthy controls (HC). We hypothesize that baseline cerebral metabolic dysfunction is a better biomarker for GM-IVH and PHH severity and response to PHH treatment. This is a Boston Children's Hospital (BCH)-institutional review board(IRB) approved, multi-site study that includes collaboration with Brigham and Women's Hospital (BWH) and Beth Israel Deaconess Medical Center (BIDMC). Pei-Yi Lin receives funding from The National Institute of Health (NIH) to support the study and is the overall principal Investigator (PI) overseeing the study.
The purpose of this study is to determine if there is a difference in neonatal outcomes with delayed umbilical cord clamping at 30 versus 60 seconds. Our primary outcome will be intraventricular hemorrhage (IVH) (bleeding in the brain) in these infants.
The investigators hypothesize that Recorded Home Oximetry (RHO) utilization will not increase rates of respiratory-related re-hospitalizations and ED visits, and will not impair growth compared to standard oxygen management protocols. Evidence-based specific consensus guidelines for home regulated oxygen management do not currently exist. Current strategies for infants requiring outpatient supplemental home oxygen include brief checks of oxygen status during monthly clinic visits. Although the infants stay on monitors, no data in between visits is obtained to ensure that infants can maintain oxygen levels after weans are made. Before finally allowing oxygen to be removed, many centers also require an overnight sleep study in the hospital, to make sure that the infant's oxygen levels stay safe when the infant is in deep sleep. Because these methods rely solely on assumptions rather than individually recorded data, an infant's time on supplemental oxygen may be prolonged or insufficient. This study will evaluate both the currently used accepted therapy and a method of weaning that involves recording and sending oxygen data for analysis in between clinic visits. Premature infants who require home oxygen therapy at time of discharge who meet eligibility criteria will be randomized into two arms: Arm A ("Standard therapy"): Infants' oxygen will be increased, decreased, or maintained based on brief structured assessments during monthly clinic visits. Arm B (Recorded Home Oximetry (RHO)): Infants will have the same monthly clinic assessments as in Arm A, but also will utilize Recorded Home Oximetry (RHO) to potentially increase, decrease or maintain oxygen between monthly visits. Parents of all infants will be interviewed using structured quality-of-life questionnaires at the beginning and ending of the oxygen management process. Health care utilization (emergency department visits and rehospitalizations) and growth will be assessed 6 months after discontinuation of oxygen. The investigators overall objective is to determine whether Recorded Home Oximetry (RHO) can improve caregiver quality of life, and can shorten Home Oxygen Therapy (HOT) duration and eliminate need for polysomnogram, without compromising safety. The investigators will determine respiratory-related re-hospitalizations, emergency department (ED) visits, and growth parameters to confirm safety of the proposed weaning strategies.
The aim of this prospective noninterventional study is to evaluate the clinical application of Numeta® in preterm infants and critically ill neonates in comparison to individualized prescribed parenteral nutrition. With the prescription software Cato-PAN® (by Cato software solutions) exact valid prescriptions for ordering parenteral nutrition solutions for premature infants are compared. Each PN solution is prescribed individually as well as with Numeta. Prescriptions were mirrored with respect to weight, venous approach, total volume and amount of enteral feeding, 24h medication and flipped vice versa. The key nutrient for calculating Numeta prescriptions was protein. The results of PN prescriptions were compared with each other/ESPGHAN recommendations. The investigators hypothesize that nutrimental content of Numeta prescriptions is equal to individually prescribed .parenteral nutrition solutions
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.
It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.
Transitional formulas (22 kcal/oz) are recommended for infants less than 35 weeks gestation at birth. However, few data are available related to follow-up of infants receiving these formulas who were 28-34 weeks gestation at birth. Primary hypothesis: Provision of supplemental vitamin D to a transitional formula will lead to higher serum 25-hydroxyvitamin D (25-OHD) levels and no infant with a serum 25-OHD less than 20 ng/mL when assessed at approximately 52 weeks post-menstrual age (PMA).
Regional tissue oxygenation (rStO2) can be monitored by near-infrared spectroscopy. The investigators planned a SafeBoosC phase II trial to test if a reduction of the burden of hyper- and hypoxia can be accomplished during the first three days of life in infants born before 28 completed weeks of gestation. The investigators developed a treatment guideline and a randomised trial design to evaluate if cerebral rStO2 spent out of range in %hours can be reduced by 50%. The present trial is a non-randomised pilot study of the intervention in 10 infants.