Ibuprofen for PDA in Premature Babies

Overseen By Nadya Ben Fadel, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Ottawa Hospital Research Institute

Must be taking: NSAIDs

Disqualifiers: Congenital heart disease, Genetic malformations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how different doses of Ibuprofen affect very premature babies with a common heart issue called PDA, where a blood vessel that should close after birth remains open. Researchers aim to determine how Ibuprofen, a common treatment for PDA, impacts blood flow to critical areas like the brain and kidneys. Babies born before 29 weeks with a PDA requiring treatment might be suitable candidates, especially if they haven't received Ibuprofen in their first week. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment benefits more patients, offering a chance to contribute to improving care for premature babies.

Will I have to stop taking my current medications?

The trial information does not specify if participants must stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that both high-dose and standard-dose ibuprofen can help close a PDA (patent ductus arteriosus) in premature babies. A PDA is a small blood vessel in the heart that doesn't close properly after birth, potentially causing health issues.

High-dose ibuprofen reduces the need for surgery to close the PDA compared to standard doses. However, limited information exists on its safety and effectiveness for very early preterm babies (less than 26 weeks gestation).

Standard-dose ibuprofen is widely used and generally well-tolerated. It is as effective as indomethacin in closing a PDA and may have fewer side effects.

Overall, both high and standard doses of ibuprofen are common treatments for PDA in premature babies, supported by extensive research. Always consult healthcare professionals to understand what this means for specific situations. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using high-dose ibuprofen for treating Patent Ductus Arteriosus (PDA) in premature babies because it offers a potentially more effective dose compared to the standard treatment. Most treatments for PDA, including the standard ibuprofen regimen, focus on closing the ductus arteriosus with anti-inflammatory effects. However, the higher dose of ibuprofen could enhance the efficiency of this process, potentially leading to quicker results. By exploring this approach, doctors hope to improve outcomes for vulnerable infants by reducing the time needed for the PDA to close, which could lead to faster recovery and fewer complications.

What evidence suggests that this trial's treatments could be effective for PDA in premature babies?

This trial will compare the effectiveness of high-dose ibuprofen with standard-dose ibuprofen in closing a PDA (patent ductus arteriosus) in premature babies. Research has shown that both high-dose and standard-dose ibuprofen can help close a PDA. High-dose ibuprofen appears more effective, significantly reducing the need for surgery compared to standard doses. One study found that high-dose ibuprofen reduced the need for surgery by about two-thirds. Standard-dose ibuprofen also shows positive results, with PDA closure rates over 60% in some cases. Both doses aim to close the PDA, but the higher dose may lead to better outcomes in avoiding surgery. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for preterm infants born before 29 weeks of gestation who have a heart condition called hsPDA, detected by echocardiogram between 7-21 days old and need treatment as decided by their doctor.

Inclusion Criteria

I was born before reaching 29 weeks of pregnancy.

My baby needs medicine for a heart issue detected by an echo test, as per NICU guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive three doses of Ibuprofen (either standard-dose or high-dose) to treat hsPDA

3 days

Daily monitoring (in-person)

Monitoring

Near-infrared spectroscopy (NIRS) is used to assess the effects of Ibuprofen on oxygen supply to the brain, kidney, and abdominal regions

3 days

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of feeding intolerance and gastrointestinal bleeding

28 days

Regular check-ups (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• High Dose Ibuprofen
• Standard Dose Ibuprofen

Trial Overview The study tests two doses of Ibuprofen (standard and high) to treat hsPDA in premature babies. It also uses a device called NIRS to monitor how the drug affects oxygen supply to the brain, kidneys, and abdomen.

How Is the Trial Designed?

Group I: Group 1 infants Active Control 1 Intervention

(n=15) will receive three doses of standard-dose Ibuprofen. (10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Group II: Group 2 infants Active Control 1 Intervention

(n = 15) will receive three doses of high-dose Ibuprofen Motrin. (20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26007314/

The Effect of Oral High-dose Ibuprofen on Patent Ductus ... Conclusion: The high-dose oral ibuprofen seems to be more effective than the current standard dose regimen for PDA closure in premature neonates without ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35404294/

Efficacy and safety of high versus standard dose ibuprofen ... High dose ibuprofen significantly decreased the rates of PDA ligation compared to standard dose (RR 0.33, 95% CI 0.16 -0.70, 5 studies, N = 309). Interpretation ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01243996

High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in ... Patent ductus arteriosus can be treated effectively with intravenous indomethacin and ibuprofen, leading to permanent ductal closure in 60% to 80% of infants [3 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2305582

Trial of Selective Early Treatment of Patent Ductus ... We conducted a multicenter, randomized, double-blind, placebo-controlled trial evaluating early treatment (≤72 hours after birth) with ibuprofen for a large ...

5. jamanetwork.com jamanetwork.com/journals/jamapediatrics/fullarticle/2766727

Effect of Nonintervention vs Oral Ibuprofen in Patent Ductus ... The PDA closure rate at 1 week after randomization was significantly higher with ibuprofen (11 [34%]) than nonintervention (2 [7%]) in infants ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01243996?term=AREA%5BConditionSearch%5D(%22Ductus%20Arteriosus,%20Patent%22)&rank=9

High-dose Ibuprofen for Patent Ductus Arteriosus (PDA) in ... Recently, Sperandio et al. reported that high-doses of indomethacin (1 mg/kg: fivefold the usual dose) were safe and effective in closing PDA in 98.5% of ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1526054225000570

Current approaches to the patent ductus arteriosus These findings suggest that early ibuprofen treatment may not provide a consistent benefit and could even be harmful in some subgroups. Table 1.

8. publications.aap.org publications.aap.org/pediatrics/article/155/5/e2025071425/201674/Patent-Ductus-Arteriosus-in-Preterm-Infants

Patent Ductus Arteriosus in Preterm Infants High-dose ibuprofen for patent ductus arteriosus in extremely preterm infants: a randomized controlled study . Clin Pharmacol Ther. 2012.

9. cps.ca cps.ca/en/documents/position/patent-ductus-arteriosus

Management of the patent ductus arteriosus in preterm ... Exercise caution when treating extremely preterm infants (<26 weeks GA) with high-dose ibuprofen due to limited safety and efficacy data.