A new clinical trial happening in the BC Women’s Hospital Neonatal Intensive Care Unit (NICU) aims to identify safe and effective treatments to prevent brain hemorrhage in extremely premature infants born before 26 weeks gestation, allowing these infants to grow up and lead full, healthy lives.
Last fall, Dr. Souvik Mitra and the Better Outcomes for the Sickest and Tiniest (BOOST) research team were awarded a spring project grant from CIHR, funding the pilot phase of the Single-dose Prophylactic Indomethacin in extremely preterm infants (SPIN) pilot clinical trial.
The SPIN trial is an international, multi-site trial involving NICUs across Canada and the United States. It will be led by the BC Women’s NICU, with additional sites in Alberta, Ontario, Nova Scotia, Pennsylvania, and Texas. For the current pilot phase, the team plans to enrol 100 participants across all sites. Once the pilot is completed, the hope is to enrol an addition 400 participants for a total sample of 500 extremely premature infants.
Dr. Mitra previously worked on a survey of parents of extremely premature babies, as well as adults who had been born extremely premature, to understand the research priorities that could lead to improved care for this population. Brain hemorrhage, or bleeding, is an unfortunately common issue in extremely premature babies, and it can have devastating side effects ranging from death to life-long neurological impairments and motor function disorders like cerebral palsy. In survey responses, safely preventing brain bleeding was identified as a high priority.
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that is used to treat pain in conditions such as arthritis and tendonitis. It has also been used as a preventive intervention to reduce the risk of brain hemorrhage in extremely premature infants. Indomethacin is highly potent and carries a high risk of side effects, such as gut injury, compared to other, milder NSAIDs. Because of this, some doctors are hesitant to use indomethacin in extremely premature infants and must carefully weigh the benefits of the drug with the potential harms for this very vulnerable patient group.
Indomethacin is traditionally given to extremely premature babies in three intravenous doses. Recent research suggests that a single dose may be as effective for the purpose of reducing risk of brain hemorrhage, but this has yet to be tested in extremely premature infants. If a single dose of indomethacin is found to be as effective as three doses, the finding could improve clinician confidence in prescribing indomethacin to prevent brain bleeds in extremely premature infants, with reduced potential for severe side effects. This, in turn, will help to reduce the incidence of brain bleeding in the smallest babies, and ensure more of them grow up to be healthy.
Dr. Mitra and team hope to begin recruiting for the pilot in early spring 2026.