With official publication of the findings in the Nov. 7 issue of The New England Journal of Medicine, obstetricians are breathing better, too. Caffeine has been widely used to help premature infants breathe better, but until now, nobody really knew whether the drug's benefits outweigh its risks.
You can almost hear the sigh of relief in comments from study leader Barbara Schmidt, MD, a professor at McMaster University in Hamilton, Ontario, Canada, and the University of Pennsylvania in Philadelphia.
"It definitely gives hope to parents," Schmidt says in a news release. "Of all the drugs we use in the neonatal intensive care unit, caffeine is the first to have been shown conclusively to reduce long-term disability in very preterm babies."
The international study looked at nearly 2,000 premature babies with very low birth weights ranging from 1.1 to 2.75 pounds. Half the babies were treated with caffeine and half received an inactive placebo.
Even with caffeine, the babies struggled to survive. By ages 18 to 21 months, more than 40% of the babies treated with caffeine either died or suffered a neurodevelopmental disability such as cerebral palsy. But that's better than the 46% of placebo-treated babies who had the same outcomes.
Overall, caffeine cut the rate of cerebral palsy from 7.3% to 4.4% (a 42% reduction) and cut the rate of cognitive delay from 38.3% to 33.8% (a 19% reduction). Caffeine had no significant effect on rates of death, deafness, and blindness.
In an editorial accompanying the study, Stanford University researcher David K. Stevenson, MD, notes that 16 very-low-birth-weight infants would need to be treated with caffeine to prevent one death or one case of cerebral palsy, cognitive delay, deafness, or blindness.
Caffeine did not affect children's growth rates at this early age. However, the children in the study will be followed until school age to see whether the benefits of caffeine persist and whether new risks become evident.
Much of caffeine's benefit is due to the fact that it allows children to breathe on their own much sooner. However, a lot of the drug's effect remains unexplained.
Nevertheless, the findings support continued use of caffeine as a treatment for prematurity.
"We can now conclude that the possible risks of [caffeine] therapy have been 'carefully balanced against the treatment gains' and the gains of therapy outweigh the risks," Stevenson concludes.