NO therapy holds great promise for tiniest preemies

September 1, 2006

Neonatologists have become good at keeping tiny newborns alive, but a distressing percentage of these babies suffer lasting lung and brain damage after their sojourn in the neonatal intensive care unit (NICU). Now, two large, multicenter clinical studies have shown that treatment with inhaled nitric oxide (NO) can prevent chronic lung disease in some very-low birth-weight (VLBW) premature infants and, when used within 48 hours after birth, protect them from brain injury. (Both studies appear in the July 27, 2006 edition of

Neonatologists have become good at keeping tiny newborns alive, but a distressing percentage of these babies suffer lasting lung and brain damage after their sojourn in the neonatal intensive care unit (NICU). Now, two large, multicenter clinical studies have shown that treatment with inhaled nitric oxide (NO) can prevent chronic lung disease in some very-low birth-weight (VLBW) premature infants and, when used within 48 hours after birth, protect them from brain injury. (Both studies appear in the July 27, 2006 edition of N Engl J Med.)

The two studies involved nearly 1,400 VLBW infants treated at 37 medical centers. Both involved infants born at less than 34 weeks' gestation who weighed between 500 and 1,250 g at birth and who required ventilation. In the first study, nearly 800 babies were given either low-dose inhaled NO or placebo (a harmless gas) starting within the first 48 hours of life and continuing through 21 days or until they no longer needed assistance breathing.

Inhaled NO appeared to cut the risk of broncho-pulmonary dysplasia (BPD) in half among babies who weighed between 1,000 and 1,250 g at birth. Significantly fewer babies treated with NO developed brain damage on brain ultrasonography. The risk of brain damage was reduced by half in treated babies who weighed between 750 and 1,000 grams.

Said John Kinsella, MD, lead author of the second study: "We have limited tools to improve lung outcomes in these infants and even fewer to reduce brain injury. That's the source of the excitement about these findings."

No adverse effects were apparent in the course of the study by Kinsella and his colleagues. All babies in the two studies will be followed for two years.