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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01755728
Study type Interventional
Source Hillel Yaffe Medical Center
Contact
Status Completed
Phase Phase 3
Start date January 1, 2013
Completion date December 31, 2018

See also
  Status Clinical Trial Phase
Completed NCT02396004 - NIRS in PDA VLBW Infants N/A
Completed NCT05321849 - Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure
Completed NCT04379843 - The Efficacy of Implementing a Treatment Algorithm in Managing Patent Ductus Arteriosus (PDA) in the Extremely Low Birth Weight Neonatal Population.
Recruiting NCT01149564 - Comparison of Oral and Intravenous Ibuprofen for PDA Treatment in Premature Infants Phase 1/Phase 2