IV Acetaminophen and Patent Ductus Arteriosus

Albany Medical College

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Ibuprofen; Drug: Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT03008876

4683

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 1 minute to 2 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

acetaminophen

Experimental group

Description:

Group of patients randomized to receive acetaminophen to treat their PDA

Treatment:

Drug: Acetaminophen

ibuprofen

Active Comparator group

Description:

Group of patients randomized to receive ibuprofen to treat their PDA

Treatment:

Drug: Ibuprofen