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Nonsteroidal Anti-Inflammatory Drug
Indomethacin for Premature Birth (SPIN Trial)
Phase 3
Waitlist Available
Led By Souvik Mitra, MD, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Extremely preterm infants born less than 26 completed weeks of gestational age and/or extremely low birth weight infants born less than 750g
Be younger than 18 years old
Must not have
Decision to withhold/withdraw life-sustaining treatments
Receipt of prophylactic or therapeutic hydrocortisone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 (±6) months postmenstrual age (pma)
Awards & highlights
Pivotal Trial
Summary
"This trial aims to study the use of a single low-dose of a medicine called indomethacin in preventing severe brain bleeding in babies born very early. Currently, the standard treatment involves three doses
Who is the study for?
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.
What is being tested?
The trial is testing if a single dose of indomethacin can improve survival without severe brain bleeding compared to a placebo. Babies are randomly assigned to receive either the drug or placebo within 12 hours of birth.
What are the potential side effects?
Indomethacin may cause side effects on the gut and could potentially interact harmfully with other medications used in neonatal care.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My baby was born before 26 weeks or weighed less than 750g at birth.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have chosen not to receive treatments that would prolong my life.
Select...
I am taking hydrocortisone as a preventive or treatment measure.
Select...
My unborn baby has been diagnosed with kidney issues.
Select...
My unborn baby has been diagnosed with a heart condition that requires immediate attention after birth.
Select...
I am currently on inhaled nitric oxide for acute pulmonary hypertension.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 (±6) months postmenstrual age (pma)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 (±6) months postmenstrual age (pma)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Survival without severe intraventricular hemorrhage (sIVH)
Secondary study objectives
Acute kidney injury (AKI)
Chronic pulmonary hypertension
Grade 3 Bronchopulmonary dysplasia (BPD)
+8 moreOther study objectives
Health Economic outcomes
Pharmacokinetic outcomes
Side effects data
From 2014 Phase 4 trial • 270 Patients • NCT019572151%
Vascular rupture
1%
Drug eruption
1%
Gingival bleeding
1%
Application site pruritis
1%
Inflammation
1%
Upper respiratory tract infections
1%
Nasopharyngitis
1%
Ligament sprain
1%
Pruritis
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Indomethacin Patch
Placebo Patch
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Single-dose prophylactic indomethacin - SPINExperimental Treatment1 Intervention
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.
Group II: ControlPlacebo Group1 Intervention
Equal volume saline placebo administered intravenously over 20 mins
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Indomethacin
2011
Completed Phase 4
~5790
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,416 Total Patients Enrolled
7 Trials studying Premature Birth
2,355 Patients Enrolled for Premature Birth
Souvik Mitra, MD, PhDPrincipal InvestigatorUniversity of British Columbia