A recently published medical paper might change the course of the treatment of persistent patent ductus arteriosus (PDA), a congenital heart defect, in preterm infants, from surgery and drugs to nonintervention.
The research team, led by Professor Park Won-soon of the Pediatrics Department at Samsung Medical Center, said Tuesday that the nonintervention approach was non-inferior to the conventional treatment in preterm infants with PDA. The study has been published in the latest issue of JAMA Pediatrics.
PDA refers to a condition in which an artery duct maintaining the fetus's blood circulation in the womb remains open even after birth.
PDA is likely to cause serious complications such as endocarditis or pulmonary edema, and even death. On diagnosis, surgery, or interventional procedures or drugs are used to close arterial ducts.
However, preterm infants find it hard to endure such treatments, and side effects cannot be ruled out. Recently, researchers have paid more attention to nonintervention to wait for a natural closure of arterial duct, the research team said.
The research team conducted a double-blind, randomized, placebo-controlled noninferiority clinical trial on 142 preterm infants born between 2014 and 2018. The researchers divided the infants into two groups – 70 received the conventional treatment and the other 72, nonintervention.
In the nonintervention group, too much fluid could increase the blood flow and burden the baby’s heart. Thus, the researchers restricted fluid intake based on the infant’s body weight, serum sodium concentration, osmolality, and urine volume.
In the conventional treatment group, the infants received ibuprofen.
The results showed that 89 percent of the conventional treatment group and 82 percent of the nonintervention group underwent PDA closure.
Only 44 percent of the nonintervention group showed bronchopulmonary dysplasia (BPD) incidence or death, versus 50 percent of the conventional treatment group.
“PDA is very common among preterm infants, and conventional treatments cause side effects frequently. Thus, it is crucial to prove the effectiveness of the nonintervention,” said Professor Chang Yun-sil of the Samsung Medical Center, one of the researchers of the study.
Professor Sung Se-in at Samsung Medical Center, another researcher in the team, said naturally inducing PDA closure through meticulous fluid restriction and mechanical ventilation was very meaningful, given the side effects of conventional therapies.