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Background Methylxanthines reduce the frequency of apnea of prematurity and the need for mechanical ventilation during the first seven days of therapy. It is uncertain whether methylxanthines have other short- and long-term benefits or risks in infants with very low birth weight.
Methods We randomly assigned 2006 infants with birth weights of 500 to 1250 g during the first 10 days of life to receive either caffeine or placebo, until drug therapy for apnea of prematurity was no longer needed. We evaluated the short-term outcomes before the first discharge home.
Results Of 963 infants who were assigned to caffeine and who remained alive at a postmenstrual age of 36 weeks, 350 (36 percent) received supplemental oxygen, as did 447 of the 954 infants (47 percent) assigned to placebo (adjusted odds ratio, 0.63; 95 percent confidence interval, 0.52 to 0.76; P<0.001). Positive airway pressure was discontinued one week earlier in the infants assigned to caffeine (median postmenstrual age, 31.0 weeks; interquartile range, 29.4 to 33.0) than in the infants in the placebo group (median postmenstrual age, 32.0 weeks; interquartile range, 30.3 to 34.0; P<0.001). Caffeine reduced weight gain temporarily. The mean difference in weight gain between the group receiving caffeine and the group receiving placebo was greatest after two weeks (mean difference, –23 g; 95 percent confidence interval, –32 to –13; P<0.001). The rates of death, ultrasonographic signs of brain injury, and necrotizing enterocolitis did not differ significantly between the two groups.
Conclusions Caffeine therapy for apnea of prematurity reduces the rate of bronchopulmonary dysplasia in infants with very low birth weight. (ClinicalTrials.gov number, NCT00182312
[ClinicalTrials.gov]
.)
Source Information
From the Departments of Clinical Epidemiology and Biostatistics (B.S., R.S.R., A.O.) and Pediatrics (B.S.), McMaster University, Hamilton, Ont., Canada; the Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Australia (P.D., L.W.D.); the Department of Pediatrics, McGill University, Montreal (K.J.B.); the Department of Pediatrics, University of Toronto, Toronto (A.O.); the Department of Pediatrics, University of British Columbia, Vancouver, Canada (A.S.); and the Department of Pediatrics, James Cook University, Middlesbrough, United Kingdom (W.T.).
Address reprint requests to Dr. Schmidt at the McMaster University Medical Center, Rm. 3N11E, 1200 Main St. W., Hamilton, ON L8N 3Z5, Canada, or at schmidt{at}mcmaster.ca.
Related Letters:
Caffeine for Apnea of Prematurity
Coulter D. M., Hand I. L., Noble L. M., Schmidt B., Roberts R. S., Davis P., the Caffeine for Apnea of Prematurity Trial Investigators
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N Engl J Med 2006;
355:958-960, Aug 31, 2006.
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