VANCOUVER – The long-standing practice of endotracheal suctioning in nonvigorous neonates born with meconium-stained amniotic fluid does not reduce adverse outcomes, finds an open-label, randomized trial conducted among 175 term singleton neonates at a tertiary care hospital in India.
Although this practice has been used since the 1970s, it has not been rigorously tested in randomized trials, noted lead investigator Dr. Sushma Nangia, a neonatologist and professor of pediatrics at Lady Hardinge Medical College in New Delhi.
In a statement addressing neonatal resuscitation, the American Academy of Pediatrics and American Heart Association found "insufficient evidence to recommend a change in the current practice" (Pediatrics. 2010;126:e1400-13).
Dr. Sushma Nangia
Trial results showed that 26% of the neonates who were not intubated and suctioned developed meconium aspiration syndrome, compared with 32% of their intubated and suctioned counterparts, a nonsignificant difference, researchers reported at the annual meeting of the Pediatric Academic Societies. The distribution of syndrome severity was also statistically indistinguishable.
Additionally, 5% of the neonates in the nonsuctioned group and 10% in the suctioned group died, another nonsignificant difference.
Rates of other adverse outcomes also were essentially the same, except that the nonsuctioned neonates actually had significantly shorter durations of respiratory distress (19 vs. 43 hours) and mechanical ventilation (25 vs. 43 hours).
"In nonvigorous full-term neonates born to mothers with meconium-stained amniotic fluid, our study demonstrated that not performing endotracheal suction to clear the airway during neonatal resuscitation did not increase the incidence of meconium aspiration syndrome or predispose to death," Dr. Nangia commented.
Session attendee Dr. Martin Keszler of Brown University, Providence, R.I., said, "Congratulations for having the courage to do this important study. All of us have been wondering about it, but it’s a practice so deeply ingrained that at least in our litigious environment, it would be very difficult to do. ... I think that this is a very important study because it can reassure future investigators to get the courage up to do this very important work."
"Certainly, it was encouraging that [no endotracheal suctioning] was no worse than control. It even seems that it was better. ... I wonder if you could speculate ..., is the intervention truly harmful and are we really better off leaving them alone?" he asked.
"We really don’t have the numbers that are required to do kind of an equivalence study," Dr. Nangia replied. "So this is just the pilot where we have 175 babies."
Another attendee asked, "With these results, can you give us an idea of the sample size you need to prove [the findings] particularly in the babies with thick meconium? How many babies will you need to test the hypothesis?"
Given the incidence of meconium aspiration syndrome, "from a national perinatal database, we think we would require about 480 babies to study the difference," said Dr. Nangia.
Dr. Nangia disclosed no relevant conflicts of interest.