IV Acetaminophen and Patent Ductus Arteriosus

Not Applicable

Completed

• Conditions: Patent Ductus Arteriosus
• Interventions: Drug: Acetaminophen; Drug: Ibuprofen

• Registration Number: NCT03008876
• Lead Sponsor: Albany Medical College

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-30
• Study Start: 2017-01-01
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-05
• Last Update Posted: 2019-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• preterm infants 23-30 weeks gestation,
• PDA requiring treatment

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
acetaminophen	Acetaminophen	Group of patients randomized to receive acetaminophen to treat their PDA
ibuprofen	Ibuprofen	Group of patients randomized to receive ibuprofen to treat their PDA

Primary Outcome Measures

Name	Time	Method
Rate of PDA Closure	3 days	PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

Secondary Outcome Measures

Name	Time	Method
Change in PDA size	3 days	Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete

Trial Locations

Locations (1)

Albany Medical Center Neonatal Intesive Care Unit; 🇺🇸 Albany, New York, United States