Treatment of a PDA With Acetaminophen in Preterm Neonates: Exploring Various Indications

Albany Medical College11 enrolled

Overview

This study will evaluate the use of acetaminophen in preterm infants when a patent ductus arteriosus (PDA) is of concern. We will perform two simultaneous prospective observational studies over a 3 year period. The first will be of infants with clinically significant PDAs beyond 14 days of life who are medically treated with acetaminophen as a means to avoid surgical ligation, and the second will be of infants who received acetaminophen for a PDA closure during the first 2 weeks of life as a result of ibuprofen, the current standard of care in our NICU, contraindication due to medical status.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patent Ductus Arteriosus

Interventions

AcetaminophenDRUG

Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.

Eligibility

Medical Language ↔ Plain English

Inclusion Criteria: * Infants born at 23 0/7 to 29 6/7 weeks gestation, with PDA determined by medical team to need treatment and infant is beyond 14 days of life. Exclusion Criteria: * Congenital heart disease Pneumonia Pulmonary hypertension Pulmonary hemorrhage ALT and AST ≥ 2X the upper limit of normal (=AST\> 150 U/L, ALT\>90 U/L) Sepsis/meningitis Abnormal chromosomes Hydrops Major congenital malformations

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

Change in PDA size

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