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

Trial Summary

What is the purpose of this trial?

Babies who are born very prematurely are often born with murmurs in the heart. In preterm babies, one of the most common causes of murmur is the presence of a PDA. This is the persistence of a connection that normally exists in the baby before it is born, connecting between the major blood vessels that leave the heart. In term babies, this channel closes shortly after birth when normal adult circulation is achieved. However, in preterm babies, the PDA can remain open, which can lead to multiple problems in the baby. Our current standard of treatment in the Neonatal Intensive Care Unit (NICU) is to perform cardiac ultrasound (echocardiogram) in all babies less than 29 weeks gestation to diagnose the presence of hsPDA. We also use an echocardiogram to follow the PDA until complete closure. If present, the standard treatment in the NICU is to give medication, usually Ibuprofen, a non-steroidal anti-inflammatory drugs (NSAID), to close the PDA. Near-infrared spectroscopy (NIRS) is a new type of device to detect oxygenated blood supply to the brain, kidney, and abdominal regions. This device is used to assess the effects of Ibuprofen on oxygen supply to these three regions.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+