Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Part of paid clinical trials in Roseville, California.

Sponsor
University of British Columbia
Study ID
NCT06572917
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Extreme Prematurity
  • Intraventricular Hemorrhage
  • Morbidity;Newborn

Eligibility Criteria

Sex
ALL
Age
0 Hours - 12 Hours
Healthy Volunteers
Not accepted

Interventions

  • Indomethacin — DRUG
    Single dose of 0.1 mg/kg dose intravenous indomethacin as a slow infusion over 20 mins
  • Placebo — DRUG
    Single dose of intravenous normal saline placebo as a slow infusion over 20 mins

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2028
Completion
Mar 31, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Single-dose prophylactic indomethacin - SPIN
    Infants randomized to the SPIN group will receive a single 0.1 mg/kg dose of intravenous indomethacin within 12h of birth as a slow infusion over 20 mins.
  • Placebo Comparator: Control
    Equal volume saline placebo administered intravenously over 20 mins

Primary Outcome Measure

Survival without severe intraventricular hemorrhage (sIVH) [ Time Frame: through hospital discharge (approximately 20 weeks postnatal age unless death occurs first) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Kaiser RosevilleRosevilleCalifornia95661
Shayna Gaman-Bean, MD
[email protected]
UC Davis HealthSacramentoCalifornia95817
Steven McElroy, MD
[email protected]
University of Pittsburgh School of MedicinePittsburghPennsylvania15224-1334
Toby Yanowitz, MD, MS
[email protected]
Texas Health Harris Methodist Hospital Fort WorthFort WorthTexas76104
Ziad Alhassen, MD
[email protected]
817-250-2000
Welcome to Baylor Scott & White HealthFort WorthTexas76104
Ziad Alhassen, MD
[email protected]
817-926-2544

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Kaiser Roseville· Roseville, CAUC Davis Health· Sacramento, CAUniversity of Pittsburgh School of Medicine· Pittsburgh, PATexas Health Harris Methodist Hospital Fort Worth· Fort Worth, TXWelcome to Baylor Scott & White Health· Fort Worth, TX

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