Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen) for Premature Birth

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
The Rotunda Hospital, Dublin, Ireland
Premature Birth+2 More
Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen) - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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).

Eligible Conditions

  • Premature Birth
  • Patent Ductus Arteriosus After Premature Birth

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: 6-10 days post treatment initiation

36 weeks PMA
Composite of pre-discharge mortality or any grade BPD
Day 10
PDA treatment success
At 36 weeks PDM
Severity of BPD at 36 weeks PDM using Jensen's criteria
Day 250
Mortality
Day 250
Duration (days) of invasive or non-invasive respiratory support
Further exposure to pharmacological PDA treatments
NEC ≥ stage 2A
Need for diuretic use
Need for systemic steroids
Procedure for PDA closure
Sepsis
Day 7
Renal or hepatic dysfunction

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Combination Therapy
1 of 2
Standard Clinical Practice - Monotherapy
1 of 2
Experimental Treatment
Non-Treatment Group

310 Total Participants · 2 Treatment Groups

Primary Treatment: Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen) · Has Placebo Group · Phase 2

Combination TherapyExperimental Group · 2 Interventions: Acetaminophen Injection, Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen) · Intervention Types: Drug, Drug
Standard Clinical Practice - MonotherapyPlaceboComparator Group · 2 Interventions: Ibuprofen 20 mg/mL oral suspension or Ibuprofen lysine 10 mg/mL injection solution (Neoprofen), Sodium chloride 0.9% injection · Intervention Types: Drug, Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-10 days post treatment initiation
Closest Location: Mount Sinai Hospital · Toronto, Canada
Photo of Toronto 1Photo of Toronto 2Photo of Toronto 3
2011First Recorded Clinical Trial
9 TrialsResearching Premature Birth
494 CompletedClinical Trials

Who is running the clinical trial?

Mount Sinai Hospital, CanadaLead Sponsor
178 Previous Clinical Trials
63,982 Total Patients Enrolled
5 Trials studying Premature Birth
1,161 Patients Enrolled for Premature Birth
McMaster Children's HospitalOTHER
33 Previous Clinical Trials
15,711 Total Patients Enrolled
3 Trials studying Premature Birth
213 Patients Enrolled for Premature Birth
The Rotunda HospitalOTHER
6 Previous Clinical Trials
1,114 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
588 Previous Clinical Trials
1,467,751 Total Patients Enrolled
10 Trials studying Premature Birth
3,285 Patients Enrolled for Premature Birth
Amish Jain, MD PhDPrincipal InvestigatorMOUNT SINAI HOSPITAL

Eligibility Criteria

Age < 18 · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.