Journal of perinatology : official journal of the California Perinatal Association
Acetaminophen; Administration, Intravenous; Administration, Oral; Conservative Treatment; Ductus Arteriosus; Ductus Arteriosus, Patent; Female; Humans; Ibuprofen; Indomethacin; Infant, Extremely Premature; Infant, Newborn; Male; San Francisco; Treatment Outcome; Vasoconstriction
OBJECTIVE: To evaluate the effectiveness of drugs used to constrict patent ductus arteriosus (PDA) in newborns < 28 weeks.
METHODS: We performed a secondary analysis of the multi-center PDA-TOLERATE trial (NCT01958320). Infants with moderate-to-large PDAs were randomized 1:1 at 8.1 ± 2.1 days to either Drug treatment (n = 104) or Conservative management (n = 98). Drug treatments were assigned by center rather than within center (acetaminophen: 5 centers, 27 infants; ibuprofen: 7 centers, 38 infants; indomethacin: 7 centers, 39 infants).
RESULTS: Indomethacin produced the greatest constriction (compared with spontaneous constriction during Conservative management): RR (95% CI) = 3.21 (2.05-5.01)), followed by ibuprofen = 2.03 (1.05-3.91), and acetaminophen = 1.33 (0.55-3.24). The initial rate of acetaminophen-induced constriction was 27%. Infants with persistent moderate-to-large PDA after acetaminophen were treated with indomethacin. The final rate of constriction after acetaminophen ± indomethacin was 60% (similar to the rate in infants receiving indomethacin-alone (62%)).
CONCLUSION: Indomethacin was more effective than acetaminophen in producing ductus constriction.
Liebowitz, Melissa; Kaempf, Joseph; Erdeve, Omer; Bulbul, Ali; Håkansson, Stellan; Lindqvist, Johanna; Farooqi, Aijaz; Katheria, Anup; Sauberan, Jason; Singh, Jaideep; Nelson, Kelly; Wickremasinghe, Andrea; Dong, Lawrence; Hassinger, Denise C; Aucott, Susan W; Hayashi, Madoka; Heuchan, Anne Marie; Carey, William A; Derrick, Matthew; Wolf, Ilene Sue; Kimball, Amy; Sankar, Meera; Leone, Tina; Perez, Jorge; Serize, Arturo; and Clyman, Ronald I, "Comparative effectiveness of drugs used to constrict the patent ductus arteriosus: a secondary analysis of the PDA-TOLERATE trial (NCT01958320)." (2019). Articles, Abstracts, and Reports. 3270.