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Recent Publications

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Active Research

Cutting-edge research continues at UF Sepsis and Critical Illness Research Center

Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure

Sponsor: Ikaria

Co-PI: Catalina Bazacliu, Julie Baines

The investigators in this study are concerned about the harmful effects of oxygen exposure in newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm babies greater than 34 weeks gestation. The purpose of this research study is to evaluate if giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the total amount of time a patient requires supplemental oxygen.

 

Adequate Breast Milk for Improved Health of Very Low Birth Weight Preterm Infants

Sponsor: National Institutes of Health/National Institute of Nursing Research

PI: Leslie Parker

The goal of this study is to improve milk volume and decrease time to lactogenesis stage II (when milk “comes in”) in mothers of premature, very low birth weight (VLBW) infants. Results have the potential to reduce short/long-term health complications and costs of lengthy hospital stays. Results are also expected to (a) fill an important knowledge gap about relationships between timing of milk expression, lactogenesis stage II, and milk volume post-delivery in mothers of VLBW infants, and (b) influence protocols.

 

Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

Sponsor: National Institutes of Health/National Institute of Nursing Research

PI: Leslie Parker, Co-I: Josef Neu

The goal of this study is to improve the nutritional and health status of premature, very low birth weight (VLBW) infants. Results have the potential to reduce short/long-term health complications and costs of lengthy hospital stays by improving nutritional status and decreasing complications. Results are also expected to (a) fill an important knowledge gap about safety and necessity of routine gastric residual measurements, and (b) influence protocols and practices regarding routine GR measurement in this vulnerable population.

 

Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants

Sponsor: Infant Bacterial Therapeutics

PI: Josef Neu

 

Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants

Sponsor: Gerber Foundation

PI: Josef Neu

 

Refaunation of Donor Human Milk with Mother’s Own Milk

Sponsor: Medela

PI: Josef Neu, PI Proxy: Nicole Cacho (PGY6)

This study examines the impact of colonizing donor milk with mother’s own milk, which would provide a proportion of the mother’s human milk microbiome to the infant and increase potential health promoting and protective effects of the donor breast milk. If these specific human milk microbes do fill an important role in well-being of the infant, these studies will be a critical step in developing the most appropriate techniques to supply these potentially beneficial bacteria to these vulnerable preterm infants.

 

Neuropathology & Neuroprotection in Aneurysmal Subarachnoid Hemorrhage (SAH)

Sponsor: Florida Department of Health

PI: Michael Weiss

 

Neuroprotection Mediated by Medical Gas

Co-PI: Michael Weiss

Inhalational gases are attractive to the bedside clinician caring for neonates with HIE because they have minimal side effects and can be easily titrated and rapidly stopped if side effects develop.  Three potential inhalational agents that could act synergistically with hypothermia are carbon monoxide (CO), inhaled nitric oxide (iNO) and helium.  Studies during the last decade have demonstrated that inert gases may be promising therapies following HI injury.  The Xenon gas been the most promising inhaled gas to date, however the translational utility is limited by cost.  Our long-term goal is to utilize inhalational gases as a therapy for neonates with HIE.

 

Melatonin as a neuroprotective therapy in neonates with HIE undergoing hypothermia

Sponsor: Thrasher Fund

PI: Michael Weiss

This project will examine the safety and dosing of enteral melatonin in infants with HI undergoing hypothermia. The phase 0/1 study will examine the pharmacodynamics, pharmacokinetics, and safety and effectiveness of enterally-administered melatonin in reducing oxidative stress and the inflammatory cascade in neonates undergoing hypothermia. In addition, outcomes at 18-22 months will be performed. The study will be carried out in the Florida Neonatal Neurologic Network, which the PI founded.

 

Clinical Utility of Blood-Based Biomarkers for the Management of Neonatal Hypoxic Ischemic Encephalopathy

Sponsor: American Heart Association

PI: Michael Weiss

Current monitoring and evaluation of HIE, outcome prediction, and efficacy of hypothermia treatment rely on a combination of a neurological exam, EEG, and neuroimaging. However, these methods do a poor job in identifying non-responders to hypothermia. Consequently, the development of a simple, inexpensive, non-invasive, rapid biochemical test is essential to identify candidates for therapeutic hypothermia, to distinguish responders from non-responders and to assess outcome. This research is the first step needed to treat neonates with HIE employing a personalized medical approach using serum proteins GFAP and UCH-L1 as biomarkers and by monitoring neonates responses to therapeutic hypothermia. These biomarkers will aid in the direct care by providing a rapid test to predict outcomes and select candidates who are likely to benefit from therapeutic hypothermia and gauge a response to the neuroprotective intervention.

 

Florida Neonatal Neurologic Network

PI: Michael Weiss

The purpose of this study is to create a detailed medical and sample database of infants born with HIE.

 

Preterm EPO Neuroprotection Trial (PENUT TRIAL)

Sponsor: National Institutes of Health/National Institute of Neurologic Disorders and Stroke

Site PI: Michael Weiss

Preterm Epo Neuroprotection (PENUT) Trial is a randomized, multi-center, placebo-controlled trial designed to test the efficacy of erythropoietin (Epo) for the neuroprotection of extremely premature infants The aim of this NINDS funded trial is to assess whether early high dose Epo will improve survival without neurodevelopmental impairment (NDI) in infants born between 24 and 28 weeks of gestation. 940 preterm infants will be enrolled at 19 centers across the U.S. Infants will be assessed at 2 years of age to see whether Epo treatment improved neurodevelopmental outcomes.

 

Detection and Quantification of Neonatal Intraventricular Hemorrhage Using EIT

Sponsor: Electrical Geodesics Inc

Site PI: Michael Weiss

Dense array EEG and EIT (electrical impedence tomography) are new technologies that can add to information needed to diagnose neurological problems in infants – both preterm and term. The investigators propose a method to test these technologies in the preterm population to determine its safety and ease of use.

 

The Role of the Inflammasome in Neonatal Sepsis

Sponsor: National Institutes of Health/National Institute of General Medical Sciences

PI: James Wynn

Newborns, particularly those born prematurely, have a very high risk of death or life-long complications due to systemic infections-associated sepsis known also as “blood poisoning”-despite being treated with antimicrobial drugs. We discovered that a key blood protein interleukin 1b, which is important for defense against infections, is grossly deficient in neonatal sepsis. In this proposal, we will determine the mechanism for this defect and new means to improve diagnosis and treatment of neonatal sepsis.