Pediatric Newborn Medicine Current Clinical Studies

Baby Seq
DPNBM Site Investigator: Richard Parad, MD, MPH
Overall Principal Investigators: Robert Green, Alan Beggs, Project #2:  Richard Parad, MD, MPH
Overall Aim: To determine whether genomic sequencing of a newborn infant confers benefit to the infant or family. 
Study Population: Well newborns
Study Contact:  Richard Parad, MD, MPH

Breast Milk Nutrition Study
DPNBM Site Investigator: Mandy Brown Belfort, MD, MPH
Overall Principal Investigator: Mandy Brown Belfort, MD, MPH
Overall Aim: To assess the nutritional content of maternal breast milk.
Study Population: Premature infants ≤32 weeks ≥ 14 days old planning to provide breast milk exclusively.
Study Contact:  Mandy Brown Belfort, MD, MPH and Caroline Palmer, BS 

Bumetanide Treatment of Neonatal Seizures: Pilot Study
DPNBM Site Investigator: Helen Christou, MD
Overall Principal Investigator: Janet Soul
Overall Aim: To assess the usefulness of Bumetanide treatment for seizures in newborn infants
Study Population: Newborns at postconceptual age of 33 to 44 weeks who are at risk of seizures or suspected seizures due to asphyxia/HIE, intracranial hemorrhage, suspected or confirmed stroke, CNS infection, genetic syndrome, brain malformation, metabolic disorder
Study Contact: Avantika Singh, Research Fellow
 (617) 355-6369; page# 5401

CC10 Treatment for Prevention of Chronic Lung Disease in Preterm Infants
DPNBM Site Investigator: Richard Parad, MD, MPH
Overall Principal Investigator: Jonathan Davis 
Overall Aim: To evaluate CC10 as a potential preventive treatment for neonatal chronic lung disease (Interventional FDA orphan funded trial).Study Population: NICU Infants <29 weeks, enrolled within 4 hrs of birth
Study Contact:  Richard Parad, MD, MPHEmily Langner, MA

Icterometer Jaundice Ruler
DPNBM Site Investigator: Anne CC (S.) Lee, MD, MPH
Overall Principal Investigator: Anne CC (S.) Lee, MD, MPH
Overall Aim: To test a newly developed method of assessing a newborn infant’s level of jaundice that can be applied in under-resourced settings.
Study Population: Well newborns
Study Contact:  Anne CC (S.) Lee, MD, MPH

Infant Brain Oxygen Metabolism Study (NIRS)
DPNBM Site Investigators: Brian Walsh, MD, Terrie Inder, MBChB, MD
Overall Principal Investigators: Ellen Grant , Mari Franceschini 
Overall Aim: To evaluate ways to improve cerebral monitoring of the extremely preterm infant with specific focus on intermittent hypoxic episodes.
Study Population: Inclusion: Premature infants born <32 weeks and <72 hours of age or are intubated.  Exclusion: Contraindication to NIRS probe to scalp, or major congenital anomaly 
Study Contact: Brian Walsh

Infant Brain Oxygen Metabolism Study (NIRS)
DPNBM Site Investigator: Brian Walsh, MD, Terrie Inder, MBChB, MD
Overall Principal Investigator: Ivy Lin, Mari Franceschini
Overall Aim: To assess brain health in premature infants who have had IVH and PHH.
Study Population: Studies in 4 groups:GM/IVH, PHH, infants with ventriculomegaly, healthy control.
Study Contact: Ivy Lin 

Maternal Outcomes and Neurodevelopment Effects of Antiepileptic Drugs (MONEAD)
DPNBM Site Investigator: Linda Van Marter, MD, MPH
Overall Principal Investigators: Page Pennell, MD, Kimford Meador
Overall Aim: To evaluate maternal and neonatal outcomes of maternal anti-epileptic drug therapy 
Study Population: Pregnant women with epilepsy and their infants
Study Contact:  Linda Van Marter, MD, MPH

Nutrition & Brain Development Study
DPNBM Site Investigator: Terrie  Inder, MBChB, MD
Overall Principal Investigators: Ellen Grant, Terrie Inder, MBChB, MD
Overall Aim: To evaluate the use of MRI to determine whether there are differences in brain development depending on the primary mode of nutrition (breastfeeding vs. formula).
Study Population: Well newborns
Study Contact:  Marie Drottar, Alana Matos, Thea Francel

Nutritional Health of Pregnant Women
DPNBM Site Investigator: Sarbattama Sen, MD
Overall Principal Investigator: Sarbattama Sen, MD
Overall Aim: To determine whether the addition of prenatal vitamin supplementation will improve outcomes of obese mothers and their infants.
Study Population: Pregnant women with BMI > 30
Study Contact: Annie Penfield-Cyr, BS

Parenting in the NICU
DPNBM Site Investigator: Lianne Woodward, PhD
Overall Principal Investigator: Lianne Woodward, PhD
Overall Aim: Parent interview to learn more about parents’ experiences while their infant is hospitalized in the Newborn Intensive Care Unit (NICU).
Study Population: All infants and mothers with LOS > 1 week
Study Contact: Alyssa Morris, BS

PDA Effects on Tissue Oxygenation and End-Organ Function
DPNBM Site Investigators: Lauren Ruoss, Linda Van Marter, MD, MPH 
Overall Principal Investigator: Lauren Ruoss
Overall Aim: To determine the association between PDA and cardiac indices echo tissue oxygenation and if there is association in AKI, NEC Pulm Hem, IVH.
Study Population: Inclusion: Infants < 29 weeks EGA and <34 weeks PMA Exclusion: Infants who have major congenital anomalies
Study Contact: Lauren Ruoss

Perinatal Brain Injury: Potential of Innovative NIRS to Optimize Hypothermia
DPNBM Site Investigators: Mohamed El-Dib, MDTerrie Inder, MBChB, MD
Overall Principal Investigator: Ellen Grant 
Overall Aim: To determine if an index of cerebral oxygen metabolism (CMRO2i) measured by frequency domain near infrared spectroscopy (FDNIRS) in combination with Diffuse Correlation Spectroscopy (DCS) in babies with neonatal encephalopathy will predict outcomes up to 2 years of age.
Study Population: Newborns of gestational age ≥33 weeks diagnosed with neonatal encephalopathy 
Study Contact:  Mohamed El-Dib, MD

POM Study
DPNBM Site Investigator:  Terrie Inder, MBChB, MDSaima Aftab, MD 
Overall Principal Investigator: Terrie Inder, MBChB, MD
Overall Aim: To investigate the impact of maternal dietary supplementation with pomegranate juice on the placenta and on subsequent newborn brain development and function.
Study Population: Pregnant women between 24 weeks and 34 weeks gestation with an estimated fetal weight less than the 5th percentile on the Doubilet growth curve.
Study Contact: Stephanie Lynch, MPHZachary Sletterink, BA 

Project SOLVE
DPNBM Site Investigator: Michael Prendergast, MB BCh BAO, PhD
Overall Principal Investigator: Michael Silverstein 
Overall Aim: To determine whether a six week problem-solving educational program decreases new mothers’ stress and depression.
Study Population: NICU mothers who meet economic criteria
Study Contact: Michael Prendergast, MB BCh BAO, PhD

Prolonged and Severe Thrombocytopenia in Neonates
DPNBM Site Investigator: Linda Van Marter, MD, MPH
Overall Principal Investigator: Martha Sola-Visner
Overall Aim: Mathematical modeling of prolonged and severe thrombocytopenia
Study Population: NICU infants < 42 weeks PMA with persistent thrombocytopenia > 5 days with plt <60 or receiving plt for count <100
Study Contact:  Yvonne Sheldon, Linda Van Marter, MD, MPH

Specialized Center of Research (SCOR) in Lung Biology Database and Biorepository
DPNBM Site Investigator: Linda Van Marter, MD, MPH
Overall Principal Investigators: Stella Kourembanas, MDLinda Van Marter, MD, MPH
Overall Aim: To evaluate factors contributing to chronic lung disease and other serious complications of prematurity. 
Study Population: BWH NICU infants born before 29 completed weeks of gestation 
Study Contact:  Linda Van Marter, MD, MPH

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