Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants - The ACEDUCT Trial

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Maximum Age: 6 months
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
John Hunter Hospital
ACTIVE_NOT_RECRUITING
Newcastle
Royal North Shore Hospital
ACTIVE_NOT_RECRUITING
St Leonards
Canada
Royal Alexandra Hospital
NOT_YET_RECRUITING
Edmonton
McMaster Children's Hospital
RECRUITING
Hamilton
Centre Hospitalier de l'Université Laval
NOT_YET_RECRUITING
Québec
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Hong Kong Special Administrative Region
Prince of Wales Hospital
NOT_YET_RECRUITING
Shatin
Ireland
The Rotunda Hospital
RECRUITING
Dublin
Contact Information
Primary
Laura Thomas, MSc
laura.thomas@sinaihealth.ca
416-586-4800
Time Frame
Start Date: 2022-12-12
Estimated Completion Date: 2027-04
Participants
Target number of participants: 310
Treatments
Experimental: Combination Therapy
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And study drug (intravenous acetaminophen 15 mg/kg/dose IV q6h for 3 days).
Placebo_comparator: Standard Clinical Practice - Monotherapy
Intravenous or enteral ibuprofen, as decided by clinical team, in the standard clinical dose used in participating NICUs (typically, for neonates \< 7 days old - 10 mg/kg/dose on day 1, 5 mg/kg/dose q24h on days 2 and 3; for neonates \> 7 days old - 20 mg/kg/dose on day 1, 10 mg/kg/dose q24h on days 2 and 3) And Placebo \[(0.9% saline IV q6h for 3 days).
Authors
Afif EL Khuffash
Related Therapeutic Areas
Sponsors
Collaborators: Prince of Wales Hospital, Shatin, Hong Kong, Royal Alexandra Hospital, McMaster Children's Hospital, John Hunter Hospital, Royal North Shore Hospital, Centre Hospitalier de l'Universite Laval (CHUL), The Rotunda Hospital, Sunnybrook Health Sciences Centre
Leads: Mount Sinai Hospital, Canada

This content was sourced from clinicaltrials.gov