TCNH Current Research

TCNH Current Research 

Stay informed about new research studies led by our TCNH neonatologists here.

A Phase I, Safety and Feasibility of Metformin Treatment in Infants after Perinatal Brain Injury

PI: Dr. Brian Kalish

Funding: New Frontiers in Research Fund Exploration Grant

A phase I, randomized controlled trial of metformin in infants affected by HIE, to assess the safety and feasibility of metformin administration in infants, and to measure the pharmacokinetics and pharmacodynamics of metformin in infants with HIE.

A Safety and PK/PD Study of Oral L-Citrulline Supplementation in Infants with Evolving BPD

PI: Dr. Estelle Gauda and Dr. Bonny Jasani

Funding: Garry Hurvitz Centre for Brain & Mental Health (GH-CBMH) Dr. Karen Pape Health Outcomes Catalyst Grant

The purpose of this study is to determine the safety of oral L-citrulline in premature infants with BPD±PH and those recovering from NEC who are able to tolerate oral feeds as well as to evaluate the pharmacokinetic and pharmacodynamic profile of L-citrulline supplementation in preterm infants with post surgical NEC and BPD±PH.

Cerebral Function Monitoring in Neonatal Abstinence Syndrome

PI: Dr. Michael Sgro and Dr. Douglas Campbell

The modified Finnegan Scoring System is the most widely used tool for diagnosis and management of newborns with NAS.  Scores for seizures or ‘general convulsions’ are heavily weighted in the scale and can have a significant impact on clinical assessment and management. We currently rely on subjective measures to assign this score and manage these newborns. In this pilot study we will use aEEG monitoring, also known as Cerebral Function Monitoring (CFM), to more objectively understand the neurological activity and seizure burden in these newborns. The study will take place at St. Michael’s Hospital and St. Joseph’s Health Centre.

Co-administration of acetaminophen with ibuprofen to improve duct-related outcomes in extremely premature infants - The ACEDUCT Trial

PI: Dr. Amish Jain

Funding: Canadian Institutes of Health Research (CIHR)

The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment). This study will take place at Mount Sinai Hospital and Sunnybrook Health Sciences Centre.

Discontinuation of resuscitation in NRP algorithm - exploring health care practitioner perspectives on guideline recommendations as well as practice considerations

PI: Dr. Mary Woodward

Funding: Canadian Pediatric Society

This study will use an explanatory sequential mixed methods approach to assess health care provider perspectives on neonatal resuscitation program recommendations for discontinuation of resuscitation, and better understand the contextual circumstances and challenges with clinical practice and decision making in prolonged neonatal codes, as well as explore challenges around shared decision making and communication with families when resuscitation is discontinued. This study will take place at The Hospital for Sick Children and McMaster University.

Dynamics of Immune Modulating Cells (IMCs) in Neonates with Hypoxic Ischemic Encephalopathy (HIE)

PI: Dr. Amr El-Shahed

A prospective, observational study of the changes in the blood level of CD34+, myeloid-derived suppressor cells (MDSC) and progenitor cells in neonates with HIE during cooling and after rewarming.

Effect of Postnatal Steroids on Cerebral and Splanchnic Oxygenation and Perfusion in Neonates with Bronchopulmonary Dysplasia

PI: Dr. Amr El-Shahed

A prospective, observational study of the changes in cerebral and splanchnic oxygenation after postnatal steroid therapy using non-invasive Near Infrared Spectroscopy (NIRS) in preterm infants with bronchopulmonary dysplasia. Longitudinal changes in tissue oxygenation before, during and after steroid therapy will be analyzed and correlated with the changes in hemodynamic and ventilation parameters and short-term outcomes.

Family Integrated Care (FICare) in critically ill preterm infants in the NICU: FICarePlus

PI: Dr. Karel O’Brien

Funding:  University Health Network (UHN) Mount Sinai Hospital (MSH) Academic Medical Organization (AMO) Innovation Fund

Family Integrated Care (FICare), designed at Mount Sinai Hospital, teaches parents to be the primary caregivers for their infants alongside healthcare providers in the NICU. In early studies, FICare infants had increased weight gain and breastfeeding at discharge, and parents also reported less stress and anxiety. FICare has only been studied in stable non-ventilated infants in NICUs; this study will apply the same model to critically ill infants, who face more adverse outcomes and may gain similar or greater benefits.

FICare Home

PI: Dr. Jennifer Young

Funding: University Health Network (UHN) Mount Sinai Hospital (MSH) Academic Medical Organization (AMO) Innovation Fund

The FICare Home program aims to empower NICU parents with confidence to care and advocate for their infant(s) following NICU-discharge and give families a network of support with knowledge of preterm birth. The FICare Home program will connect families with the Toronto Public Health HBHC home visiting program and veteran parents through community peer-to-peer support groups organized with Life With a Preterm Baby, a program designed to provide peer to peer support for families transitioning from the NICU to their first years at home.

Helping underdeveloped lungs with cells (HULC)

PI: Dr. Michael Dunn and Dr. Elizabeth Asztalos

Funding: Canadian Institutes of Health Research (CIHR)

This study will evaluate the response of lung tissue  in infants with BPD who have received mesenchymal stem cells.

High Resolution Immunophenotyping in the NICU

PI: Dr. Brian Kalish

The characterization of the immune system using single cell genomics from peripheral blood mononuclear cells (PBMCs) from infants in the newborn intensive care unit (NICU).

Improving antenatal counselling provided in presentations of expected preterm birth at the limits of viability in non-tertiary centres

PI: Dr. Kyong-Soon Lee

The objective of this study is to better understand challenges in providing counselling at the limits of viability in non-tertiary centres and inform development of an antenatal counselling tool to support community providers. This study will take place at The Hospital for Sick Children and Mount Sinai Hospital.

Interprofessional ethics education in tertiary NICU's in Canada- where do we stand today?

PI: Dr. Mary Woodward

Through a survey distributed to health care providers working in tertiary and quaternary NICUs in Canada, we aim to examine how ethics is taught and what kinds of current ethics education initiatives exist across Canadian NICUs and to understand what gaps exist, and whether current initiatives meet the needs of providers to help inform a curricular intervention.  This study will take place at The Hospital for Sick Children and McMaster University.

Intranasal human Milk as a Stem Cell Therapy for Neonatal Hypoxic Ischemic Encephalopathy

PI: Dr. Rebecca Hoban

Funding: New Frontiers in Research Fund Exploration Grant

This trial is to determine whether fresh intranasal human milk (HM) can be safely delivered as stem cell therapy to preterm IVH patients within a 3-hour window from HM expression and to identify signals which would indicate whether intranasal HM stimulates the repair of damaged brain tissue. Outcomes will be compared to HM fed historical IVH controls. Recruitment will take place in The Hospital for Sick Children and Mount Sinai Hospital NICUs in Toronto.

Lactoferrin Infant Feeding Trial_Canada (LIFT_Canada)

PI: Dr. Elizabeth Asztalos

Funding: Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia

This is a multicentre, phase III, 2-arm, masked randomized controlled trial. The primary hypothesis is that oral bovine lactoferrin (bLF), through its antimicrobial, antioxidant and anti-inflammatory properties, will reduce the rate of mortality or major morbidity in very low birth weight (VLBW) preterm infants. This study will take place in nine NICUs across Canada.

Maximizing mother’s own milk: individualized fortification to improve neurodevelopmental of infants born less than 1250 grams (MaxiMoM-INFORM)

PI: Dr. Eugene Ng

Funding: Canadian Institutes of Health Research (CIHR)

This study will evaluate both growth and neurodevelopmental outcomes at 2 years of age in infants who have been randomized to one of three fortification approaches to optimize growth in the very small preterm infants. This study will take place at Sunnybrook Health Sciences Centre, Mount Sinai Hospital, and The Hospital for Sick Children.

Model-Informed Precision Dosing (MIPD) in Neonates-Prospective Feasibility Trial

PI: Dr. Tamorah Lewis

Funding: National Institute of Health  (NIH)

Current weight-based dosing of drugs in the NICU leads to variable drug exposure and variable clinical effect. Implementing a precision dosing tool may improve drug dosing for certain drugs with high pharmacokinetic variability. We will implement an EPIC-imbedded precision dosing tool which uses a pharmacokinetic model to combine multiple real-time patient factors (age, weight, kidney function, etc) pulled from the electronic health record, to create a custom dose of a drug. The two drugs that will be dosed using this new tool are enoxaparin and fosphenytoin.

NeoVest Feasibility Study

PI: Dr. Doug Campbell

Funding: St. Michael’s Hospital Foundation, Angels Den

The aim of the present study is to demonstrate the feasibility of applying negative pressure NIV, that is synchronized and proportional to the infant’s respiratory demand.

Remote Ischemic Conditioning in Hypoxic-Ischemic Encephalopathy (HIE): Feasibility and Safety Pilot Study.

PI: Dr. Brian Kalish

This trial will test the hypothesis that remote ischemic conditioning (RIC) is safe and feasible as an adjunctive treatment in neonates with HIE during therapeutic hypothermia, and to study the physiologic response to RIC in patients with HIE receiving therapeutic hypothermia.

Surveillance of Short- and Long-term Outcomes of Infants Born to COVID-19 Positive Mothers: A Prospective Epidemiological Study

PI: Dr. Ashraf Kharrat

The objectives of this study are to identify and describe the neonatal and infantile outcomes during the first year of life, of infants born to mothers who are COVID-19 positive; to investigate the relationship between the timing in pregnancy of disease acquisition (ie: first, second or third trimester) and outcomes; and to ascertain whether different care pathways (feeding routines, isolation from positive caregivers, etc.) play a role in these infant outcomes. This study will take place in Level II and III NICUs across Ontario.

SWIFT: Studying the Wider Impact of Faster Genetic Testing in Critical Care

PI: Dr. Linh Ly 

Funding: Norman Saunders Complex Care Initiative Grant

This project will describe the attitudes, expectations and experiences of families who are offered rapid genetic testing in their critically ill newborn children, and the perceived clinical utility of rapid genetic testing from the perspective of healthcare providers. This study will take place at The Hospital for Sick Children, Mount Sinai Hospital, and Sunnybrook Health Sciences Centre .

The Association Between Maternal Oral Inflammation and The Composition of Breast Milk: A Cohort Study

PI: Dr. Michael Sgro

This study aims to assess whether there is an association between post-partum maternal oral inflammation and breast milk composition as well as infants’ gut microbiome.

The RECOVER Study: Remote Early intervention for Cerebral palsy to improve Outcomes using Virtual care following pERinatal asphyxia

PI: Dr. Linh Ly

Funding: The Hospital for Sick Children Foundation, Dr. Karen Pape Neuroplasticity Clinical Research Fund 

A five year, prospective, randomized, controlled trial (RCT) to assess the effect of a virtual early intervention care delivery model in the provision of therapy to enhance the neurodevelopmental trajectory of infants with brain injury. In addition, we will enhance our understanding of the social and parental contributors to outcomes and the early health economic impact of a virtual clinic. 

The Role of Adipokines in Breathing Control and the Development of Lung Injury in Premature Infants

PI: Dr. Estelle Gauda

A prospective, observational study to determine the correlation between levels of adipokines, biomarkers of inflammation, oxidative stress and endothelial cell injury, intermittent hypoxia frequency, and apnea index in premature infants. This study will take place at The Hospital for Sick Children and Mount Sinai Hospital.

The Use of Breastmilk by Women Living with HIV

PI: Dr. Doug Campbell

Using a critical qualitative methodology with a participatory approach we hope to identify sociocultural tensions, marginalized and lived experiences of WLHIV, specifically, those who immigrated from HIV-endemic countries regarding infant feeding decisions in Canada. 

Understanding the impact of an adverse intrauterine environment on fetal development

PI: Dr. Brian Kalish

The goal of this study is to better understand the molecular mechanisms by which an adverse intrauterine environment shapes fetal development. This study involves the prospective collection of pregnancy-associated tissue via the RCWIH Biobank, the MRC-Wellcome Trust Human Developmental Biology Resource (HDBR), and the SickKids Neuropathology Lab. Tissue collected will be used for molecular, genetic, and biochemical analysis. This study will take place at The Hospital for Sick Children and Mount Sinai Hospital.