Autologous cord blood-derived cell therapy for extremely preterm infants: An international, multicentre randomised controlled trial

Preterm infants, especially those born before 28 weeks of gestation, are at high risk of complications related to their brain and development. In this international research study conducted at multiple sites, cells (including stem cells) extracted from the baby’s own cord blood will be infused back to them. Babies will be randomised to treatment. It means half of the babies in the trial will receive their cord blood derived cells in the first two weeks of life (in some cases two infusions) in addition to routine neonatal intensive care, while the other half will only receive placebo treatment in the newborn intensive care unit. A randomised study is the most scientific way of assessing whether a treatment is beneficial. Further whether the baby receives the intervention will not be known to the parents, or the treating team. The main outcome studied in this trial will be baby’s survival at two years without major disability related to the brain. We expect that cord blood cell therapy may increase the baby’s chances of survival without any major disability, and if proven to be true at the end of this study, it may offer a new therapy for these vulnerable infants.