Innovative pediatric clinical trials (iPCT)

A partnership with Pediatric Emergency Research Canada (PERC) .

As a program of MICYRN, KidsCAN Trials is a national hub to coordinate research, training and knowledge transfer in the safe therapeutic use of medicines for children. By federating all academic child health centres and their affiliated research institutes, KidsCAN Trials will encourage new processes and practices, new policy approaches and new ways of organizing care for children. It will catalyze the development of new research methods and new knowledge transfer tools and will foster collaboration among patients, families, child healthcare institutions, researchers, educators and regulators. The KidsCAN Trials Steering Committee has engaged PERC to test innovative clinical trial methods with a carefully selected set of four pediatric trials, using a centralized trial management structure and recruiting at 6 pediatric emergency departments in four provinces. The trials were chosen based on their potential to benefit from innovative methods as well as on the prevalence of the conditions they address.

The Innovative Pediatric Clinical Trials (iPCT) combines comparative effectiveness with implementation research and presents an integrated set of four innovative multi-centre clinical trials in pediatric emergency medicine, supported by core methodological expertise, data management, and network coordination. Our goal is to demonstrate that the proposed iPCT methods will allow the generation of evidence that will have an immediate impact on pediatric clinical decision-making. This initial step will lay the groundwork for a national network called “KIDSCAN” – a Canadian coordinating and advisory network and infrastructure to ensure best therapies for children.

1. The No OUCH trial will use a patient preference approach to randomization to evaluate the comparative effectiveness of ibuprofen alone, or in combination with acetaminophen or hydromorphone, in clinical pain relief for suspected fractures.

2. The DOSE AGE Study is a pragmatic trial that will evaluate the safety and efficacy of multiple doses of ondansetron administered post-discharge to children with acute gastroenteritis.

3. The KETODEX Study will determine if a combination of intranasal ketamine and intranasal dexmedetomidine (Ketodex) is just as effective as intravenous ketamine to sedate children undergoing realignment of a broken or dislocated bone.

4. The BIPED trial builds on previous evidence and will definitively confirm whether combination therapy with epinephrine and dexamethasone is effective in treating bronchiolitis and reducing infant hospitalizations.

These four conditions (suspected fractures, acute gastroenteritis, procedural sedation, and bronchiolitis) are estimated to affect over 17,300 children across our 6 recruiting sites every year.  These trials will serve as proof of concept and enable us to build capacity in the design, conduct, and reporting of pediatric clinical trials that could be applicable to any pediatric subspecialty. The study team, led by Dr. Terry Klassen, was awarded a SPOR Innovative Clinical Trials multi-year grant by CIHR.

The Network Coordinating Centre (NCC), located in Winnipeg at the Children’s Hospital Research Institute of Manitoba, is composed of several key positions throughout the network. The NCC provides leadership, oversees network operations, establishes and increases infrastructure for more efficient clinical trial administration.  This will include supporting researchers through their research project’s lifecycle, with a focus on contract preparation and facilitation, regulatory preparation and submission, development and establishing for adoption standardized study documents, templates and communication processes.

Network Coordinating Centre (NCC)

Terry Klassen, Nominated Principal Investigator
Tannis Erickson, Executive Director, RSU, CHRIM
Geert ‘t Jong, CHRIM
Chelsea Bowkett, Project Coordinator, CHRIM

Methods Core     

Martin Offringa, Lead
Petros Pechlivanoglou, Co-Lead 
Chris McCabe, Trial Methodologist
Gareth Hopkin, Health Economist
Jeff Round, Health Economist

Additional Participating Sites

• Winnipeg Children’s Hospital

• CHU Sainte-Justine

• BC Children’s Hospital

• McMaster University Medical Centre

• Starship Children’s Hospital, New Zealand

• Kidz First Middlemore Hospital, New Zealand

• Waikato Hospital, New Zealand

• Perth Children’s Hospital, Australia

• Monash Health, Australia

• Women’s and Children’s Hospital, Australia