Canadian Phase 2 Trial • Health Canada Approved
TRIAL OVERVIEW
The HULC-2 Study Process
Understanding what participation involves for you and your baby.
Informed Consent Discussion
The study team will invite you to participate in the HULC-2 trial and explain all study details. You will be encouraged to ask as many questions as needed to be able to make an informed decision. Your participation is voluntary.
Randomization
Your baby will randomly be assigned to a study group based on chance. You will have a 50/50 chance to be placed in either the intervention group or the control group.
Study Procedures
• Intervention Group:
If your baby is randomized to the intervention group, your baby will receive a weekly IV dose of UC-MSCs for 3 weeks.
• Control Group:
If your baby is randomized to the control group, your baby will continue to receive NICU usual care.
Data Collection Until NICU Discharge
The researchers will collect information from your baby’s medical chart from admission to the NICU until discharge/transfer.
24-Month
Follow-Up Visit
This in-person evaluation is standard for all premature babies born before 29 weeks gestational age. This visit will take about 90 minutes and will capture information about general health, growth, and neurodevelopment.
Yearly Follow-Up Questionnaire
Each year until the age of 10 years old, you will receive an online questionnaire to monitor your child’s respiratory health and any new diagnoses they may receive.
