209 - Acetaminophen versus Ibuprofen in the management of hemodynamically significant persistent ductus arteriosus in very low birth weight Infants

The pharmacological closure of hemodynamically significant Patent Ductus Arteriosus (hs-PDA) has been subject of debate in recent years. There is currently controversy in the treatment of hs-PDA, regarding what would be the best pharmacological alternative, with good efficacy and minimal side effects. Acetaminophen has emerged as one of the therapeutic alternatives.

Objective:

To evaluate the efficacy and safety of acetaminophen (Ac) versus ibuprofen (Ibu) in the treatment of hs-PDA in preterm newborns.

Design/Methods:

Prospective randomized study in preterm newborns < 32 weeks gestational age (GA) and/or < 1500 grams with echocardiographic diagnosis of hs-PDA performed by a pediatric cardiologist, within the first 2 weeks after birth, conducted between January 2017 and December 2019.

Newborns were randomized into 2 groups: Ac group at a dose of 15 mg / kg IV every 6 hours for 3 days, and Ibu group at a dose of 10 mg / kg IV the first day and then 5 mg / kg IV the second and third day. The evaluation of PDA closure was performed by echocardiography one day after treatment. For the evaluation of side effects, creatininemia, BUN, bilirubin, liver function and blood cell count, before and after treatment were performed. Statistical analyses were done using SPSS v.23 program.

Results:

120 newborns who met inclusion criteria were enrolled; 60 were randomized to Ac group and 60 to Ibu treatment group. The mean weight and GA ± SD for Ac group was 1,145 ± 339 grams and 28.3 ± 2.5 weeks, and 1,096 ± 251 grams and 27.6 ± 2.1 weeks for Ibu group.

The average pre-treatment ductal diameter was similar between both groups (Ac 2.35 mm and Ibu 2.41 mm). The rate of ductal closure with the first course of treatment was 66.7% (40/60) in the Ac group and 63.3% (38/60) in  Ibu group (p = 0.70), increasing to 88.3% and 86.7% respectively after the second course of treatment (p = 0.78). In the Ac group the need for surgical closure was 10% (6/60) and 11.7% (7/60) in the Ibu group (p = 0.77).

No significant differences between groups were observed in pre and post treatment laboratory tests. Two cases of gastrointestinal hemorrhage occurred in Ibu  group (p = 0.09). There were no differences in the most relevant morbidities between both groups.

Conclusion(s): The treatment of hs-PDA with Acetaminophen is as effective as Ibuprofen, with no evidence of adverse effects.