PENUT – Preterm Erythropoietin Neuroprotection Trial
This trial investigates whether high doses of erythropoietin followed by lower maintenance doses help protect against neurodevelopmental issues for babies born between 24 and 27 weeks gestation. Dr. Ellen Bendel Stenzel is the local PI. This study is closed to enrollment and in follow up portion of the study.
DOVE – Draeger Oscillatory Ventilator Evaluation
This nationwide industry-sponsored study will evaluate the safety and efficacy of the High Frequency Oscillatory Ventilation Mode (HFOV) on the Draeger Babylog VN500 ventilator for very low birth weight neonates. The ventilator is already in use on our NICU; however the device’s HFOV software has not been FDA-approved for use in the US. The mode is already approved for use in the EU and Canada. Dr. Ellen Bendel-Stenzel (PI) and Dr. Aaron Swenson are the leads for this trial.
This randomized, placebo-controlled study is evaluating the safety and efficacy of a new RSV preventative treatment (REGN2222) for late preterm infants (29 – 36 weeks gestation) who do not meet criteria for currently available RSV preventative treatment. Dr. Ellen Bendel-Stenzel is the local PI for this trial. This study is closed to enrollment and in follow up portion of the study.
Developmental Impact of NICU Exposures (DINE)
Dr. Ellen Bendel-Stenzel was awarded a pass through award from Albert Einstein College of Medicine in the amount of $708,306 for the study entitled Developmental Impact of NICU Exposures (DINE). The trial is part of a seven year NIH initiative, Environmental Influences on Child Health Outcomes (ECHO), which will fund leading researchers around the country to investigate a broad range of exposures that can impact children’s long-term health. The DINE study proposes to contribute to the ECHO program by merging four cohorts of preterm infants and examining the role of early life exposures to phthalates in neonatal intensive care units (NICUs) and their interactions with metal and stress exposures as determinants of longitudinal multisystem health outcomes as the children age. Children’s Minnesota is one of the 6 pilot sites in a total of 15 collaborating sites, and will enroll patients who participated in previous studies on our Minneapolis and St. Paul NICUs. This will include patients from both the TOLSURF and PENUT cohorts, two large multicenter trials for which Dr. Ellen Bendel-Stenzel served as the Minneapolis site PI.
A Phase 2/3 Multicenter, Multinational, Open-label study to evaluate the Efficacy and Safety of ALXN1101 in Neonates with Molybdenum Cofactor Deficiency (MoCD) Type A
This trial evaluates the safety and efficacy of ALXN1101 in patients with MoCD Type A. It is a multicenter, multinational trial being coordinated by our clinical geneticist colleague Dr. Gunter Scharer and Dr. Ellen Bendel-Stenzel.
HEAL – High-dose Erythropoeitin for Asphyxia and Encephalopathy
This study will evaluate the safety and efficacy of high-dose erthyropoeitin to improve neurodevelopmental outcomes in term babies with hypoxic ischemic encephalopathy undergoing total body cooling. This is a multicenter research trial being coordinated by our colleagues at UCSF and was submitted for NIH funding 11/15. Dr. Bendel-Stenzel is the local PI.
Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
This is a prospective, randomized, multicenter unblinded clinical trial designed to compare the efficacy of aerosolized surfactant when compared to usual care. Surfactant is traditionally given via endotracheal intubation and this alternative method of delivery may benefit some patients by supplying sufficient surfactant in a less invasive manner. Drs. Neil Mulrooney and Ellen Bendel-Stenzel are the local leads on this trial.
HEAL Ethics Ancillary Study
This trial is being developed as a 15-20 minute survey that will be administered to all parents who either joined or declined participation in our HEAL trial. The study aims to better understand parental preferences during the informed consent process to aid in development of a more parent-friendly and informative consent process that leaves families feeling respected while improving the consenting rate for neonatal clinical trials.