IV Acetaminophen and Patent Ductus Arteriosus

Patent Ductus Arteriosus Clinical Trial

Official title:

The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008876
• Other study ID #: 4683
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: July 2019
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

Inclusion Criteria:

• preterm infants 23-30 weeks gestation,

• PDA requiring treatment

Exclusion Criteria:

• infection,

• congenital heart disease,

• genetic syndrome,

• NEC,

• pulmonary hypertension,

• hydrops,

• intestinal perforation,

• grade 3 or 4 IVH,

• serum creatinine >1.5,

• previous treatment with a COX inhibitor.

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

Intervention

Drug:
• Acetaminophen
infants receive acetaminophen for treatment of their PDA
• Ibuprofen
infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

Locations

Country	Name	City	State
United States	Albany Medical Center Neonatal Intesive Care Unit	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of PDA Closure	PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.	3 days
Secondary	Change in PDA size	Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete	3 days