WEDNESDAY, May 17, 2006 (HealthDay News) -- Caffeine therapy helps protect the lungs of premature infants from damage.
That's an early finding from an international, multi-center trial designed to assess the safety of caffeine therapy for the treatment of apnea of prematurity.
Apnea of prematurity is very common in preterm infants, because their lungs are underdeveloped and the central nervous system, which automatically directs the body to breathe, is immature and often not functioning properly. It's not known exactly how caffeine therapy helps these tiny babies breathe better, but its major benefits are believed to come from its stimulant effect on the respiratory system.
"In this study, we test a treatment that has been in use for a fair bit of time, although past studies have been very limited and very short-term. Our aim was to rigorously examine the long-term safety of this treatment and the long-term effects," said study lead author Dr. Barbara Schmidt, a professor of pediatrics, clinical epidemiology and biostatistics at McMaster University Medical Center, in Hamilton, Ontario, Canada.
Although the original objective of the study was to assess caffeine therapy's safety after two years, the researchers released their findings early, when it became clear that the treatment could reduce the rate of bronchopulmonary dysplasia (BPD) -- a common type of lung damage that occurs in premature infants.
"We found clear evidence of short-term benefit," said Schmidt.
The findings appear in the May 18 issue of the New England Journal of Medicine.
Schmidt's study included just over 2,000 premature infants -- the average gestational age was 27 weeks. The babies were born in Canada, Australia and England. They were randomly assigned to receive either caffeine therapy or a placebo during the first 10 days of life, until drug therapy for apnea was no longer needed.
For the report, the researchers assessed the babies just before discharge from the hospital. They considered BPD to be present if babies needed supplemental oxygen therapy.
Overall, 36 percent of the babies who received caffeine therapy needed supplemental oxygen, compared with 47 percent of the babies on a placebo. And babies receiving caffeine therapy needed an average of one week less of ventilator therapy than babies on a placebo, according to Schmidt.
Babies on caffeine therapy did gain slightly less weight, according to the study. But there were no differences in the rates of death and brain injury between the two groups.
"The short-term outcomes are really quite reassuring," said Schmidt. "I know from doing this study that quite a few parents are anxious, but for now, it looks OK."
Schmidt's team is continuing to follow these babies, and will report its findings on caffeine therapy's safety after two years. She said the researchers have also recently received a grant to follow the children through age 5.
Dr. Eduardo Bancalari, director of the division of newborn medicine at the University of Miami Miller School of Medicine, said, "For parents, this study is reassuring. Almost all of these babies are receiving caffeine therapy, and this study shows it's effective at getting them off mechanical ventilation sooner and improves the long-term pulmonary outcome."
"It looks like caffeine may be a relatively safe drug. There's no evidence yet that caffeine has a detrimental effect," he said, but cautioned that it's too early in the trial to conclude there are absolutely no negative neurological effects from caffeine therapy. Bancalari also wrote an accompanying editorial that appears in the same issue of the journal.
"We have to wait for the follow-up. That's the main reason this trial was started. We're always concerned about these very immature babies," Bancalari added.
The National Heart, Lung, and Blood Institute has more information about bronchopulmonary dysplasia.