Research

Minnesota Neonatal Physicians, in collaboration with Children’s Hospitals and Clinics of MN, has maintained an extensive patient database since 1979. We have participated in many multi-institutional studies of neonatal care leading to peer-reviewed, medical journal publications as well as a book. Our physicians give medical presentations across the U.S. and overseas.

Multi-institutional Clinical Research Studies

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.

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.

REGN2222
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.

Toll-Like Receptors
This is a multi-site clinical trial examining genetic variations in toll-like receptors and susceptibility to chronic lung disease in very low birth weight infants. Study enrollment is currently on hold while the national Principal Investigator relocates to Children’s Mercy Hospital in Kansas City, MO. Dr. Neil Mulrooney is the local PI for this trial.

Caffeine Citrate
This is a national retrospective study evaluating the safety and efficacy of caffeine citrate for premature infants born at less than 28 weeks gestation. It will also examine clinical outcomes such as bronchopulmonary dysplasia for infants treated with caffeine. This trial is funded by the Best Pharmaceuticals for Children Act. Dr. Bendel-Stenzel is the lead on this trial.

Internal Research Grant Program Studies
Ram Cannula CPAP versus Conventional Binasal Prong CPAP
This research trial compares the efficacy of these two commonly used types of CPAP support.
The trial is a collaborative study between Dr. Neil Mulrooney, and Dr. Andrea Lampland from our Children’s Hospitals and Clinics St. Paul NICU campus.

GIRLS – Guided Imagery Reduces Stress and Improves Lactation Study
This is a trial for mothers of infants born prior to 30 weeks gestation investigating if guided imagery/mindfulness meditation while pumping helps decrease stress and increase milk production. Lactation consultant Kathy Parrish, RN is the lead on this trail.
 
CDH LHR
This research trial through the Midwest Fetal Care Center and our Neonatal Follow-up Program examines whether prenatal measurements of the lung-to-head ratio (LHR) in cases of diaphragmatic hernia can predict the need for ECMO, various co-morbidities, and long-term neurodevelopmental outcome. This study is a retrospective chart review by Dr. Ellen Bendel-Stenzel and Neonatal Fellow Dr. Erin Plummer. 

CPAM-CVR
This is a retrospective study evaluating if the congenital pulmonary airway malfunction volume ratio (CVR) correlates with lesion progression and pulmonary outcome in fetuses with congenital pulmonary airway malformations (CPAM). Data from Children’s Hospital MN is being pooled with data from the University of Michigan and Children’s Hospital – Milwaukee to create a dynamic model for prenatal counseling. The trial is sponsored by our Midwest Fetal Care Center.

Outcomes of Twin-to-Twin Transfusion Syndrome
A retrospective study evaluating neurodevelopmental outcomes of children prenatally treated with fetoscopic surgery for twin-to-twin transfusion syndrome. This trial is sponsored by our Midwest Fetal Care Center and Dr. Nina Perdue is the neonatal lead.
 

Pending Research

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. 

A Phase 2/3 Multicenter, Multnational, 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.
 

Recently Completed

TOLSURF – Trial of Late Surfactant to Prevent Bronchopulmonary Dysplasia
A multicenter, randomized, controlled and blinded trial evaluating late administration of surfactant with nitric oxide therapy on lung function in infants born at less than 28 weeks gestation. Participants were followed until 24 months corrected age to assess respiratory and neurodevelopmental outcomes. This is a multicenter research trial coordinated by our colleagues at UCSF and the initial manuscript is in press. Dr. Bendel-Stenzel is the local PI.
 

Current Publications

Our physicians often co-author publications that describe some of the current clinical trials in which we are participating. This is a list of current publications:

Randomized Trial of Late Surfactant Treatment in Ventilated Preterm Infants Receiving Inhaled Nitric Oxide. October 2015

A neonatologist is available 24/7 for referral and case consultation

1-888-455-BABY