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Showing 1-10 of 36 trials for Prematurity
Recruiting

Point-of-Care Ophthalmic Diagnostic Imaging of Retinopathy of Prematurity

Tennessee

The goal of this proposal is to develop novel HH-SECTR technology for visualizing and quantifying diagnostic disease features in prematurely born infant retinopathy of prematurity (ROP) patients that lead to more informed clinical decision making. Providing depth-resolved vascular information has not been adequately investigated for its diagnostic potential. Furthermore, we seek to identify disease features not currently accessible by standard examination methods to better inform clinical decisions.

Recruiting

"Prapela® SVS Incubator Pad for Apnea of Prematurity

Alabama · Birmingham, AL

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.

Recruiting

Retinal Microanatomy in Retinopathy of Prematurity (BabySTEPS2)

North Carolina · Durham, NC

Retinopathy of prematurity (ROP) is a disorder of development of the neural retina and its vasculature that can impact vision in vulnerable preterm neonates for a lifetime. This study tests high-speed optical coherence tomography (OCT) technology compared to conventional color photographs at the bedside of very preterm infants in the intensive care nursery, to characterize previously unseen abnormalities that can predict a need for referral for ROP treatment, or poor visual or neurological development later in life, up to pre-school age. Our long-term goal is to help improve preterm infant health and vision via objective bedside imaging and analysis that characterizes early critical indicators of ROP, and poor visual function and neurological development, which will rapidly translate to better early intervention and improved future care.

Recruiting

Genetic Variants and Susceptibility to Diseases of Prematurity in Very Low Birth-Weight Infants

Wisconsin · Milwaukee, WI

The purpose of this study is to determine if sequence variations in genes involved in the development and function of vulnerable organs increases susceptibility to chronic lung disease (CLD) and other diseases affecting premature infants, such as necrotizing enterocolitis (NEC), sepsis, patent ductus arteriosus (PDA) and intraventricular hemorrhage (IVH). The study will also determine whether measurement of certain biomarkers in serum will identify infants who will develop these complications of prematurity. Previous studies from this institution and others have identified genetic variants in some genes, such as toll like receptor genes are associated with higher risk of CLD or NEC. The interaction of these variants with other gene variants that can influence the risk of these diseases remains unclear.

Recruiting

Milk And Growth In Children (MAGIC) Born Very Preterm: A Randomized Trial

Birmingham, Alabama · Jackson, Mississippi

The goal of this multi-center randomized, parallel group trial is to determine the effect of human milk diets ranging between 180 and 200 mL/kg/day on the body composition outcomes of moderately preterm infants born between 27 and 31 weeks of gestation.

Recruiting

Vibroacoustic Study of Lung Development in Newborn Infants

District of Columbia · Washington, DC

Investigators hypothesize that premature newborns with poor cardiopulmonary performance have higher morbidities and poorer physical and cognitive developmental outcomes. Investigators further hypothesize that audible sounds combined with novel inaudible vibrations above and below human perception interpreted with transparent and auditable AI algorithms can detect and identify early gas and fluid movement anomalies not uncovered by conventional tools in an non-invasive, easy, fast, and low cost examination.

Recruiting

Imaging Retinal Vasculature in Infant Eyes

North Carolina · Durham, NC

Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.

Recruiting

Maternal Stress, Milk Composition, and Preterm Neurodevelopment

Minnesota · Minneapolis, MN

This study explores the associations between maternal stress, breastmilk composition, and feeding and neurodevelopment for preterm infants in the NICU and at 4 months corrected age.

Recruiting

Darbe Plus IV Iron to Decrease Transfusions While Maintaining Iron Sufficiency in Preterm Infants

Washington · Seattle, WA

In this phase II trial, the investigators overarching goal is to demonstrate the feasibility and potential benefit of darbepoetin (Darbe) plus slow-release intravenous (IV) iron to decrease transfusions, maintain iron sufficiency and improve the neurodevelopmental outcomes of preterm infants. Investigators hypothesize that in infants \< 32 completed weeks of gestation, combined treatment with Darbe plus Ferumoxytol (FMX) or Darbe plus low molecular weight iron dextran (LMW-ID) will: 1) be safe, 2) decrease or eliminate transfusions, 3) maintain iron sufficiency, 4) result in higher hematocrit and 5) improve neurodevelopment. Investigators further hypothesize that when compared to oral iron supplementation (standard care), IV iron will be better tolerated, with less effect on the gastrointestinal (GI) microbiome

Recruiting

The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

New York · New York, NY

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.