NCT06572917: SPIN

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Not yet recruiting Phase 2 Last updated 3 September 2025

What this trial tests

Phase 2 trial testing Indomethacin in Extreme Prematurity in 500 participants. Not yet recruiting.

Timeline

1 November 2025

Primary endpoint
31 December 2028

31 March 2031

Quick facts

Lead sponsor	University of British Columbia
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	500
Start date	1 November 2025
Primary completion	31 December 2028
Estimated completion	31 March 2031
Sites	15 locations across Canada, United States, Australia

Drugs / interventions tested

• Indomethacin (INDOMETHACIN) — full drug profile →
• Placebo

Conditions studied

• Extreme Prematurity — all drugs for Extreme Prematurity →
• Intraventricular Hemorrhage — all drugs for Intraventricular Hemorrhage →
• Morbidity;Newborn — all drugs for Morbidity;Newborn →

Sponsor

University of British Columbia

Who can join

Adults 0 Hours to 12 Hours, any sex, with Extreme Prematurity or Intraventricular Hemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 in 2 phases: First, an internal pilot phase that will enroll 104 babies born \<26 weeks or \<750 g birth weight over a period of 1 year. If the investigators are successful in achieving their target enrolment in the pilot phase, they will move on to the second phase and continue enrollment up to a total of 500 babies born \<26 weeks or \<750 g birth weight over a period of 3 years. The total of 500 babies will include the 104 babies enrolled in the first phase of the study. 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.