NCT01755728

Paracetamol (Acetaminophen) for Closure of PDA in Preterm Infants

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hillel Yaffe Medical Center · Other Government
• Sex: All
• Age: 4 Months
• Healthy volunteers: Not accepted

Summary

There is a report that acetaminophen may have a role in pharmacological closure of PDA (Patent arterial duct) in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.

Detailed description

In-uteri, the arterial duct connects between the aorta and the main pulmonary artery, thus bypassing the lungs. Since the high pulmonary pressure and the low systemic pressure, the shunt trough the arterial duct in that time is right to left. After birth, systemic pressure rises and pulmonary pressure declines. As oxygen saturation rises, and prostaglandin secretion, the arterial duct closes, usually. In preterm infants, the arterial duct may remain open after birth. At this tume the shunt would be left to right, that would cause pulmonary congestion, and systemic hypoperfusion. Ibuprofen is the treatment of choice for PDA in preterm infants. Yet, ibuprofen is not effective after two weeks of age. Moreover, there are situations that prevent treatment with ibuprofen, such as thrombocytopenia or renal failure. Surgical closure of arterial duct is an alternative treatment, if ibuprofen is contraindicated, or if it fails. Lastly, there was a report that acetaminophen may have a role in pharmacological closure of PDA in preterm infants. The investigators conducted this open label non randomized and non control study to try to support that report.

Conditions

• PDA

Interventions

Type	Name	Description
DRUG	Paracetamol	Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
DRUG	Ibuprofen	Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
PROCEDURE	Closure of PDA	Open surgery for closure of PDA

Timeline

• Start date: 2013-01-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2012-12-24
• Last updated: 2019-08-06

Locations

1 site across 1 country: Israel