Babies born prematurely can have a number of complications at birth, simply because they are brought into the world before their organs are fully developed. One complication is called patent ductus arteriosus (PDA).
PDA occurs when a small fetal blood vessel in the heart remains open after birth. Much like trying to drink through a straw with a hole in it, the condition can cause unnecessary stress on the heart and lungs, as they have to work harder to push blood throughout the body.
However, treatment for the condition remains controversial among neonatologists, cardiologists, and pediatricians alike. Results from a clinical trial published in the Journal of the American Medical Association, or JAMA, brings physicians one step closer to an answer.
Led by neonatologist Matthew Laughon, MD, MPH, the study found that using medication to treat patent ductus arteriosus was associated with higher mortality compared with an expectant, or "watchful waiting," approach.
"There is wide variation in treatment of PDA in preterm infants," said Laughon, who is a professor of perinatal-neonatal medicine at the UNC School of Medicine and lead author on the paper. "Some clinicians always treat, and some clinicians never treat. We need to know which one is better for babies"
Matthew Laughon, MD, MPH, Neonatal-Perinatal Medicine professor, Department of Pediatrics
A total of 482 extremely pre-term infants (born between 22 weeks and 28 weeks of gestation) with PDAs were enrolled in the clinical trial. All of the infants were born within affiliated hospitals of the NICHD Neonatal Research Network, a collaborative network of neonatal intensive care units across the United States.
Participants were randomized into two treatment groups: those to receive pharmacologic treatments (either acetaminophen, indomethacin, or ibuprofen) and those to receive expectant management, or a "wait and see" approach.
Researchers wanted to know which intervention would decrease the risk of death or bronchopulmonary dysplasia (BPD), a serious lung condition caused by life-saving efforts to ventilate and oxygenate into the lungs, by the time the infants reach 36 weeks adjusted age.
Through statistical analysis, researchers found that infants given expectant management had treatment had nearly double the chance of survival before 36 weeks.
"This trial showed no benefit of active treatment of the PDA in extremely preterm infants," wrote Laughon. "In fact, it identified a higher chance of survival for expectant management, consistent with emerging data on the effects of early (i.e., prior to one or two weeks after birth) pharmacologic PDA treatment."
The medications themselves, which are all commonly used to treat the PDA, can also alter the immune system, reduce blood flow to the intestine, or cause gastrointestinal mucosal injury. These effects may lead to serious conditions like sepsis or the death of intestinal tissue, called necrotizing enterocolitis.
Results from this trial will help inform new treatment strategies for preterm infants with patent ductus arteriosus, saving more lives and putting families on a path towards growth and healing.
This work was supported by The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
