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

Albany Medical College

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Drug: Acetaminophen

Study type: Observational

Funder types: Other

Identifiers

NCT03289390

4846

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 23 to 30 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

Acetaminophen to close PDA

Description:

Infants with PDA treated with acetaminophen beyond 14 days of life or in whom acetaminophen is used due to contraindication to ibuprofen

Treatment:

Drug: Acetaminophen