Caffeine Therapy Boosts Preemies' Outcomes
It cut their risk for neurodevelopmental trouble, researchers say
By Serena Gordon, HealthDay Reporter
WEDNESDAY, Nov. 7 (HealthDay News) -- Some adults joke they couldn't live without their morning coffee, but caffeine may be literally life-changing if given as treatment to tiny premature infants.
New research finds that high doses of caffeine therapy given to babies born very early -- an average of 27 weeks gestation -- reduced their risk of serious disabilities, including cerebral palsy.
"This is really good news for caregivers and parents. We now know that caffeine is definitively a treatment where the benefits outweigh the harms," said the study's lead author, Dr. Barbara Schmidt, a professor in the department of clinical epidemiology and biostatistics at McMaster University in Hamilton, Ontario, Canada. "This is actually the first drug that has been convincingly shown to reduce disability rates in these children," she added.
Schmidt's team published its findings in the Nov. 8 issue of the New England Journal of Medicine.
About 12 percent of American babies are born prematurely, according to the March of Dimes. The earlier a baby is born -- normal gestation is 40 weeks, and anything before 37 weeks is considered premature -- the more likely that baby is to have serious disabilities if he or she survives.
Because the odds are often against the tiniest babies, neonatologists quickly put into practice treatments they think might help premature infants survive with the fewest disabilities. Studies on the efficacy of such treatments often follow, and that's the case with caffeine therapy. According to Dr. Beverly Brozanski, clinical director of neonatology at Children's Hospital of Pittsburgh, caffeine therapy has been used to treat premature infants for about 10 years.
To answer the question of whether or not caffeine therapy was helping or harming premature infants with a condition known as apnea of prematurity, Schmidt and her colleagues followed a group of a little more than 2,000 infants from Canada, Australia and the United Kingdom. Apnea literally means the temporary cessation of breathing, and apnea of prematurity is a common condition in premature babies, because their lungs and central nervous system aren't yet properly developed.
The babies in the study all weighed between 500 and 1,250 grams (about 1 to 3 pounds) and were born at an average of 27 weeks' gestation. Half were randomly assigned to receive caffeine therapy, and the other half was given a placebo. According to Schmidt, the dose given to the babies is equivalent to the amount of caffeine in about six cups of coffee.
In 2006, the researchers published initial results early when they found that babies on caffeine therapy were less likely to suffer from bronchopulmonary dysplasia, a common type of lung damage that occurs in premature babies. However, at the time, they also reported that the babies on caffeine were slightly smaller than the babies on placebo, and growth restriction is always a concern in small babies.
In the current study, the researchers reported their findings when the infants reached two years old. They found that 23 percent fewer babies on caffeine therapy had died or developed a neurodevelopmental disability compared to those on placebo.
The incidence of cerebral palsy was 42 percent lower in the caffeine group, and the risk of cognitive delay was 19 percent lower for the caffeine group than the placebo group.
At the two year follow-up, the researchers found no significant differences in height, weight or head circumference.
Schmidt and her colleagues will continue to follow this group of babies and report their findings again when the children are between five and six years old. At that point, they should be able to better assess cognitive and fine motor function, looking for any subtle delays that weren't picked up when the youngsters were two years old.
The researchers believe that about half the benefit of caffeine comes from being able to take babies off mechanical ventilation sooner. They're not sure where the rest of the beneficial effect is coming from, acknowledged Schmidt. Brozanski speculated that it may be that by coming off the ventilator sooner, babies may be getting better nutrition, which would also improve their outcomes.
Whatever the cause of the beneficial effects, Schmidt said, "We now have a drug which we can confidently say can help babies."
"A lot of families worry, and we have always focused on getting babies off medications as soon as we can. But, parents can be reassured. In this group of children, caffeine is beneficial," added Bronzanski.
Volume 357:1893-1902 November 8, 2007 Number 19
Long-Term Effects of Caffeine Therapy for Apnea of Prematurity
Barbara Schmidt, M.D., Robin S. Roberts, M.Sc., Peter Davis, M.D., Lex W. Doyle, M.D., Keith J. Barrington, M.D., Arne Ohlsson, M.D., Alfonso Solimano, M.D., Win Tin, M.D., for the Caffeine for Apnea of Prematurity Trial Group
Background Methylxanthine therapy is commonly used for apnea of prematurity but in the absence of adequate data on its efficacy and safety. It is uncertain whether methylxanthines have long-term effects on neurodevelopment and growth.
Methods We randomly assigned 2006 infants with birth weights of 500 to 1250 g to receive either caffeine or placebo until therapy for apnea of prematurity was no longer needed. The primary outcome was a composite of death, cerebral palsy, cognitive delay (defined as a Mental Development Index score of <85 on the Bayley Scales of Infant Development), deafness, or blindness at a corrected age of 18 to 21 months.
Results Of the 937 infants assigned to caffeine for whom adequate data on the primary outcome were available, 377 (40.2%) died or survived with a neurodevelopmental disability, as compared with 431 of the 932 infants (46.2%) assigned to placebo for whom adequate data on the primary outcome were available (odds ratio adjusted for center, 0.77; 95% confidence interval [CI], 0.64 to 0.93; P=0.008). Treatment with caffeine as compared with placebo reduced the incidence of cerebral palsy (4.4% vs. 7.3%; adjusted odds ratio, 0.58; 95% CI, 0.39 to 0.87; P=0.009) and of cognitive delay (33.8% vs. 38.3%; adjusted odds ratio, 0.81; 95% CI, 0.66 to 0.99; P=0.04). The rates of death, deafness, and blindness and the mean percentiles for height, weight, and head circumference at follow-up did not differ significantly between the two groups.
Conclusions Caffeine therapy for apnea of prematurity improves the rate of survival without neurodevelopmental disability at 18 to 21 months in infants with very low birth weight. (ClinicalTrials.gov number, NCT00182312 [ClinicalTrials.gov] .)
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