NCT05325177

PDA Treatment With Ibuprofen and Changes in Tissue Oxygenation.

A Pilot, Randomized Controlled Study of the Effects of High Dose Ibuprofen on Cerebral and Splanchnic Tissue Oxygenation During Treatment of Hemodynamically Significant Patent Ductus Arteriosus (hsPDA) in Preterm Infants

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 29 Weeks
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Patent Ductus Arteriosus After Premature Birth

Interventions

Type	Name	Description
DRUG	Standard Dose Ibuprofen	(10-5-5 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses
DRUG	High Dose Ibuprofen	(20-10-10 mg/kg) 1 dose every 24 hours after enrollment, for a total of 3 doses

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-12-01
• Completion: 2024-12-31
• First posted: 2022-04-13
• Last updated: 2024-01-30

Locations

1 site across 1 country: Canada