Le Bonheur Children’s Hospital Trial: Intravenous Indomethacin

Intravenous indomethacin is more effective than intravenous acetaminophen in treating hemodynamically significant PDAs (hsPDAs) in very low birth weight (VLBW) infants, according to new Le Bonheur Children’s Hospital neonatology research published in the Journal of Perinatology.

Le Bonheur and the University of Tennessee Health Science Center neonatologists, led by Jennifer M. Davidson, DO, conducted a randomized trial for the treatment of hemodynamically significant PDAs (hsPDAs) in very low birth weight (VLBW) infants. Echocardiogram criteria before and after treatment showed that IV indomethacin was more effective.

“We have several options for PDA closure in these very low birth weight infants with varying levels of effectiveness including intervention by medication therapies,” said Davidson.

Commonly used medical therapies are indomethacin and ibuprofen, but these have variable success and notable side effects. Surgical PDA ligation and transcatheter PDA closure can be used if medical therapies fail to close the PDA, but each comes with risks and lack of access for some hospitals. Studies have shown that, for some neonates, acetaminophen may be equally effecting for treating hsPDAs with minimal side effects. Le Bonheur neonatologists wanted to examine this option of IV acetaminophen for treating hsPDA in VLBW infants.

To be included in the trial, infants met specific criteria including gestational age at birth between 22 and 32 weeks, birth weight less than 1500 grams, 21 days of age or less and no previous pharmacologic treatment for PDA. Infants also had to meet strict echocardiogram criteria including left to right ductal flow and two out of three of the following: ductal size greater than or equal to 1.5 mm at smallest diameter, reversal of flow in descending aorta or left atrial size to aortic root ratio greater than or equal to 1.5.

Seventeen infants received 15 mg/kg dose of IV acetaminophen every six hours for 12 doses. Twenty infants received 3 doses of IV indomethacin every 12 hours with the amount of medication based on age. Each infant had a follow-up echocardiogram within seven days of the initiation of treatment. Successful PDA treatment was defined as no longer meeting the echocardiogram inclusion criteria for hsPDA.

Results of the study showed that IV indomethacin was more effective in successful treatment of hsPDA. The rate of successful PDA closure was 55 percent when using IV indomethacin and 6 percent when using IV acetaminophen.

“Through our study of very low birth weight infants, we were unable to show successful treatment of hsPDA with IV acetaminophen when compared to IV indomethacin in preterm infants born prior to 32 weeks,” said Davidson. “In addition, many of our babies in the study treated with acetaminophen required interventional closure later on.”

If acetaminophen continues to be used as a primary treatment of hsPDA, future studies should include a different dosing strategy or route of administration to learn more about its efficacy in PDA closure.


About Le Bonheur Children’s:

Le Bonheur Children’s Hospital in Memphis, Tenn., treats children through community programs, regional clinics and a 255-bed state-of-the-art hospital. Le Bonheur serves as a primary teaching affiliate for the University Tennessee Health Science Center and trains more than 350 pediatricians and specialists each year. Nationally recognized, Le Bonheur is ranked by U.S. News & World Report as a Best Children’s Hospital. 

For more information, please call (901) 287-6030 or visit lebonheur.org. Connect with us at facebook.com/lebonheurchildrens, twitter.com/lebonheurchild or on Instagram at lebonheurchildrens.


About University of Tennessee Health Science Center:

As Tennessee’s only public, statewide, academic health system, the mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health through education, research, clinical care, and public service, with a focus on the citizens of Tennessee and the region. The main campus in Memphis includes six colleges: Dentistry, Graduate Health Sciences, Health Professions, Medicine, Nursing and Pharmacy. UTHSC also educates and trains medicine, pharmacy, and/or health professions students, as well as medical residents and fellows, at major sites in Knoxville, Chattanooga and Nashville. For more information, visit www.uthsc.edu. Find us on Facebook: facebook.com/uthsc, on Twitter: twitter.com/uthsc and on Instagram: instagram.com/uthsc.

Posted: 7/22/20

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