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New treatment option for Patent Ductus Arteriosus After Premature Birth
Official title Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
ClinicalTrials.gov ID: NCT05340582
What this study is testing
What is Acetaminophen Injection?
Acetaminophen Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for patent ductus arteriosus after premature birth.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Patent ductus arteriosus (PDA), the most common cardiovascular complication of prematurity, is associated with higher mortality and morbidities in extremely low gestational age neonates (ELGANs, \ 60% ELGANs. Treatment failure is associated with worsening rates of mortality and bronchopulmonary dysplasia (BPD), while early treatment success can achieve rates comparable to neonates without PDA.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 27
You may be able to join if
- Preterm infants born \<27+0 weeks gestational age
- Permission given by the attending clinician to approach and then consent obtained from parents
- Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
- Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
You likely can't join if
- Chromosomal anomaly
- Pre-treatment renal dysfunction defined as urine output \ 100 micromol/L
- Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94
- Platelet count \<50,000 per microliter
- Permission denied by the attending clinician to approach parents
- Parental consent not available
See the full eligibility criteria
- Preterm infants born \<27+0 weeks gestational age
- Permission given by the attending clinician to approach and then consent obtained from parents
- Diagnosis of PDA ≥ 1.5 mm on echocardiography with unrestrictive predominantly left to right shunt
- Designated to receive first treatment course with intravenous or enteral ibuprofen, as decided by the attending team.
- Chromosomal anomaly
- Pre-treatment renal dysfunction defined as urine output \ 100 micromol/L
- Pre-treatment hepatic dysfunction defined as serum aminotransferase (ALT) \> 100 units/L94
- Platelet count \<50,000 per microliter
- Permission denied by the attending clinician to approach parents
- Parental consent not available
- Previous exposure to PDA medical treatment with any drug (prophylactic indomethacin use for prevention of intraventricular hemorrhage will not be considered as PDA treatment).
The study team makes the final eligibility decision.
Where it's taking place
- Newcastle, New South Wales, Australia
- St Leonards, New South Wales, Australia
- Edmonton, Ontario, Canada
- Hamilton, Ontario, Canada
- Toronto, Ontario, Canada
- Québec, Quebec, Canada
- Shatin, NT, Hong Kong
- Dublin, Ireland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 27 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newcastle, New South Wales, Australia; St Leonards, New South Wales, Australia; Edmonton, Ontario, Canada; Hamilton, Ontario, Canada; Toronto, Ontario, Canada; Québec, Quebec, Canada and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.