Introducing NeoCAN: Building Canada’s First National Neonatal Clinical Trials Network

We are thrilled to share that our NeoCAN – Neonatal Outcomes & Accelerating Clinical Trials Network of Canada application has been successful under the Accelerating Clinical Trials (ACT) initiative.

This marks a major milestone for neonatal research in Canada.

Why NeoCAN?

Despite Canada’s strong neonatal research community, we have never had a dedicated national neonatal clinical trials network. Yet the need is clear.

Neonatal conditions such as preterm birth, congenital malformations, and hypoxic-ischemic encephalopathy remain leading causes of neonatal mortality and long-term disability worldwide. Advances in care have improved survival—even for extremely preterm infants—but many fundamental clinical questions remain unanswered, including:

• Resuscitation strategies at birth

• NICU interventions

• Long-term outcomes

Individual centres cannot answer these questions alone. Neonatal populations are small, heterogeneous, and geographically dispersed. Regulatory complexity continues to increase. Parent-important outcomes must be meaningfully integrated.

NeoCAN was created to address exactly these challenges.

Building on a Strong Foundation

NeoCAN is not starting from scratch. Network investigators currently lead or collaborate on multiple national and international phase 2 and phase 3 trials, including: HiLo, SURV1VE-2, ACEDUCT, SPIN, MVP, HULC-2, and SANE-03.

Collectively, network members have conducted more than 50 neonatal randomized trials.

This track record demonstrates that Canada has the expertise. What we have been missing is a coordinated national structure to accelerate and harmonize trial delivery.

What ACT Means

The ACT funded by CIHR supports high-functioning clinical trial networks across Canada. ACT is now launching ACT-2, which aims to support approximately 40 new or existing networks nationwide.

NeoCAN’s success within ACT positions us to be part of this national infrastructure—ensuring that neonatal research has a strong, unified voice within Canada’s clinical trials ecosystem.

Governance, Equity, and Patient Partnership

NeoCAN will be governed by a multidisciplinary Steering Committee that includes: Clinician-scientists, Biostatisticians and trial methodologists, Ethics experts, Parent-patient partners, Indigenous partners, and Equity, Diversity, and Inclusion (EDI) Champion.

The network already includes investigators across six provinces and ten academic sites, with plans to expand nationally.

Equity and inclusion are embedded from the outset, both in network governance and in trial conduct. Indigenous partnerships and respect for Indigenous data sovereignty are foundational commitments moving forward.

Parent organizations such as Canadian Premature Babies Foundation and Préma-Québec are active partners, ensuring that research questions and outcomes reflect what truly matters to families.

Training the Next Generation

NeoCAN also formalizes a strong training platform. Over the past five years, network investigators have trained more than 30 trainees. Moving forward, structured mentorship, trial methodology training, and hands-on experience within multicentre studies will help develop Canada’s next generation of neonatal trialists.

Why This Matters Now

Neonatal care is increasingly complex. International trials are accelerating. Regulatory expectations are rising. And families expect and deserve evidence-informed care.

NeoCAN provides a coordinated, standing national platform to:

• Rapidly design and deploy multicentre neonatal trials

• Harmonize data infrastructure

• Embed EDI and patient engagement

• Support early-phase innovation

• Generate Canadian-led evidence for Canadian newborns

• Participate in inetrnational trials across Canada

This ACT success marks the beginning of a new chapter for neonatal clinical trials in Canada.

We are proud of the collaborative effort that made NeoCAN possible and even more excited about what comes next.