A new clinical trial happening in the BC Women\u2019s 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.\u00a0<\/p>\n\n
Last fall,\u00a0Dr. Souvik Mitra<\/a>\u00a0and the\u00a0Better Outcomes for the Sickest and Tiniest (BOOST) research team<\/a>\u00a0were 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.<\/p>\n\n The SPIN trial is an international, multi-site trial involving NICUs across Canada and the United States. It will be led by\u00a0the BC Women\u2019s NICU,\u00a0with\u00a0additional\u00a0sites in Alberta, Ontario, Nova Scotia, Pennsylvania, and Texas. For the current pilot phase, the team plans to enrol 100\u00a0participants\u00a0across 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.<\/p>\n\n Dr.\u00a0Mitra\u00a0previously 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,\u00a0is 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.\u00a0 Indomethacin is traditionally given to\u00a0extremely\u00a0premature babies in\u00a0three\u00a0intravenous doses. Recent research suggests that a\u00a0single dose\u00a0may be as effective for the purpose of reducing\u00a0risk of\u00a0brain hemorrhage, but\u00a0this has yet to be tested in extremely premature infants.\u00a0If 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.<\/p>\n\n Dr. Mitra and team hope to begin recruiting for the pilot in early spring 2026.\u00a0<\/p>\n\n
Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) that is used to treat pain in conditions such as arthritis and tendonitis. It\u00a0has\u00a0also\u00a0been\u00a0used\u00a0as a preventive\u00a0intervention\u00a0to reduce the risk of brain hemorrhage in\u00a0extremely premature infants.\u00a0Indomethacin\u00a0is highly potent and carries\u00a0a high risk\u00a0of side effects, such as gut injury,\u00a0compared to\u00a0other, milder NSAIDs. Because of this, some doctors are hesitant to use indomethacin in extremely premature infants\u00a0and\u00a0must\u00a0carefully\u00a0weigh the benefits of the drug with the potential harms for this very vulnerable patient group.<\/p>\n\n