IV Acetaminophen and Patent Ductus Arteriosus

Albany Medical College10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patent Ductus Arteriosus

Interventions

AcetaminophenDRUG

infants receive acetaminophen for treatment of their PDA

IbuprofenDRUG

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

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 2 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Albany Medical Center Neonatal Intesive Care Unit

Albany, New York, United States

Outcomes

Primary Outcomes

Rate of PDA Closure

PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.

Time frame: 3 days

Secondary Outcomes

Change in PDA size

Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete

Time frame: 3 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.