IV Acetaminophen and Patent Ductus Arteriosus

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03008876

Enrollment

Registered

2017-01-04

Start date

2017-01-01

Completion date

2019-06-30

Last updated

2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patent Ductus Arteriosus

Keywords

neonate, acetaminophen

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.

Interventions

DRUGAcetaminophen

infants receive acetaminophen for treatment of their PDA

DRUGIbuprofen

infants receive ibuprofen, standard of care in our unit, for treatment of a PDA

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 2 Weeks

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026