Document Type : original article
Authors
- Mohamad Mehdi Bagheri 1
- Marjan Nikvarz 2
- Reza Derakhshan 1
- Zahra Daii Parizi 3
- Fateme Mirzaie 4
- Maryam Ahmadipour 1
- Zahra Kamiab 5
1 Associate Professor of Pediatric Cardiology, Department of Pediatrics, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.
2 Clinical Research Development Unit, Afzalipour Hospital, Kerman University of Medical Sciences, Kerman, Iran.
3 Associate Professor of Pediatric Neonatology, Department of Pediatrics, School of Medicine, Kerman University of Medical Sciences, Kerman, Iran.
4 Associate Professor, Department of Ob. & Gyn., Afzalipoor School of Medicine & Physiology Research Center, Kerman University of Medical Sciences, Kerman, Iran.
5 Department of Community Medicine, School of Medicine, Rafsanjan University of Medical Sciences, Rafsanjan, Iran.
Abstract
Background: Patent ductus arteriosus is a short path of fetal blood circulation through the lungs that is necessary to maintain life inside the womb. Although this duct should be closed right after birth, in some cases, it remains open and may cause life threatening complications. The present study was conducted with the aim of investigating the effectiveness of injectable acetaminophen in closing patent ductus arteriosus in term infants.
Methods: This study was conducted as a randomized, blinded clinical trial on 80 infants diagnosed with patent ductus arteriosus in the neonatal intensive care unit in Afzalipur Hospital, Kerman. The infants were randomly divided into control and intervention groups. The intervention group received injectable acetaminophen at a dose of 20 mg based on weight in the first hour and 10 mg based on weight every six hours for three days after receiving the initial dose. And the placebo group received 10% dextrose serum equal to acetaminophen amount with the same treatment intervals. Echocardiography was performed again in both groups after three days and the state of PDA closure was evaluated.
Results: Gestational age averages in the intervention and control groups were 37.88 ± 0.13 weeks and 37.95 ± 0.15 weeks, respectively (P=0.738); and the birth weight averages were 2996 ± 83.41 grams and 64.09 ± 2982 grams, respectively (P=0.899). The male gender in the intervention group (57.5%) was higher than that in the control group (40%) (P=0.158). The most common cause of hospitalization of newborns in the intervention and control groups was TTN (Transient Tachypnea of the newborn) (75.0% and 67.5%, respectively) and NAS (Neonatal Abstinence Syndrome) (15.0% and 20.0%, respectively) (P=0.985). In the intervention group with injectable acetaminophen, 85.5% of infants had their PDA closed after receiving the first course of acetaminophen, while this rate was 0.65% in the control group (P=0.016).
Conclusion: Based on the results of this study, injectable acetaminophen can effectively improve PDA disorder of term babies. While the effectiveness of routine drugs used in the treatment of this disorder decreases with increasing infants’ age, injectable acetaminophen showed its beneficial effects significantly.
Keywords
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