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Co-administration of Acetaminophen with Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants

Patent Ductus Arteriosus After Premature Birth

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, \< 27+0 weeks). Ibuprofen and acetaminophen, which act by reducing prostaglandin synthesis, are the most commonly used first and second line agents for PDA treatment across Canada. However, initial treatment failure with monotherapy is a major problem, occurring in \>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. Treatment failure resulting in prolonged disease exposure is thought to be a major contributor. Recently, combination therapy with acetaminophen and ibuprofen has emerged as a new treatment regime. Acetaminophen exerts anti-prostaglandin effect through a different receptor site than ibuprofen, providing a biological rationale for their synergistic action.

The objective of this study is to evaluate the clinical impact, efficacy and safety of combination regime (Ibuprofen + IV Acetaminophen) for the first treatment course for PDA in ELGANs vs. Ibuprofen alone (current standard treatment).

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Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    0 to 27

Critères de participation

Inclusion 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.

Exclusion Criteria:

* Chromosomal anomaly
* Pre-treatment renal dysfunction defined as urine output \< 1ml/kg/hour for the previous 24 hours or serum creatinine \> 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).

Lieu de l'étude

Royal Alexandra Hospital
Royal Alexandra Hospital
Edmonton, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Dr. Georg Schmölzer, MD, PHD

Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Amish Jain, MD PhD

McMaster Children's Hospital
McMaster Children's Hospital
Hamilton, Ontario
Canada

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Primary Contact

Amneet Sidhu, MD

Sunnybrook Health Sciences Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
Canada

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Primary Contact

Dany Weisz, MD, MSc

Étude parrainée par
Mount Sinai Hospital, Canada
Participants recherchés
Plus d'informations
ID de l'étude: NCT05340582