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

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.

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Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Heart Defects, Congenital Heart Diseases

Age range

23 week–30 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Albany Medical Center

Albany, New York, 12208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen

Drug

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

Primary outcomes

Rate of PDA closure

Time frame: 3 days

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

Time frame: 3 days

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

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Sep 21, 2017
Registry last updated: Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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