What we’re working on:
SPIN Pilot RCT: Single-dose Prophylactic Indomethacin in Extremely Preterm Infants
Extremely premature babies, born before 26 weeks gestation, are at high risk of dying or developing serious bleeding in the brain. Parents of these babies see preventing brain bleeding as one of the most important goals of care. A medicine called indomethacin, normally given through an IV in three doses, is known to lower the risk of this kind of bleeding when given shortly after birth. However, some doctors hesitate to use it due to potential side effects on the baby’s gut and possible harm when combined with other medications.
New research suggests that giving just one low dose of indomethacin may work as well as the standard three-dose treatment, but this has never been tested in extremely premature babies. To find out if this approach is safe and feasible, we designed a pilot study. In this study, babies born before 26 weeks will be randomly given either a single dose of indomethacin or a saline (salt water) placebo within the first 12 hours after birth. Babies’ health will be monitored throughout their stay in the NICU and families will be invited to complete neurodevelopmental assessments at age 2. Neither the doctors nor the researchers will know which baby received the medicine or the placebo, to make sure the results are fair and unbiased.
The study will take place in NICUs in Canada, the U.S. and Australia, and will recruit 104 extremely premature babies over 12 months. This research will help determine if a larger study should be done to test whether a single dose of indomethacin can safely reduce brain bleeding in the tiniest and most fragile newborns.
You can read more about the study at Clinical Trials.gov website.
If you have questions about the study or would like additional information, contact the study coordinator at michelle.avina@cw.bc.ca.
Resources for families
If you’d like more information, we invite you to check the following organizations: