Indomethacin for Premature Birth
(SPIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen.The investigators propose a blinded randomized controlled trial, a study design where babies born \<26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results.The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia and will enroll 500 babies born \<26 weeks or \<750 g birth weight over a period of 3 years. This study will help the investigators determine in the most unbiased way whether a single dose of indomethacin given immediately after birth in the smallest babies born \<26 weeks of gestation can safely and effectively reduce severe brain bleeding.
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications. However, it mentions possible harm when indomethacin is used with other medications, so it's best to discuss your current medications with the trial team.
Is indomethacin generally safe for human use?
What makes the drug Indomethacin unique for treating premature birth?
What data supports the effectiveness of the drug Indomethacin for premature birth?
Who Is on the Research Team?
Souvik Mitra, MD, PhD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for extremely preterm infants born at less than 26 weeks of gestation or with a birth weight under 750 grams. The study aims to include about 500 babies from NICUs in Canada, the US, and Australia over three years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive a single 0.1 mg/kg dose of intravenous indomethacin or placebo within 12 hours of birth
Follow-up
Participants are monitored for survival without severe intraventricular hemorrhage (sIVH) and other secondary outcomes
Long-term Follow-up
Assessment of neurodevelopmental impairment at 24 (±6) months postmenstrual age
What Are the Treatments Tested in This Trial?
Interventions
- Indomethacin
Indomethacin is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor