Abstract | 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:
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Authors | Barbara Schmidt, Robin S Roberts, Peter Davis, Lex W Doyle, Keith J Barrington, Arne Ohlsson, Alfonso Solimano, Win Tin, Caffeine for Apnea of Prematurity Trial Group |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 354
Issue 20
Pg. 2112-21
(May 18 2006)
ISSN: 1533-4406 [Electronic] United States |
PMID | 16707748
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright 2006 Massachusetts Medical Society. |
Chemical References |
- Central Nervous System Stimulants
- Caffeine
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Topics |
- Apnea
(drug therapy, therapy)
- Bronchopulmonary Dysplasia
(prevention & control)
- Caffeine
(pharmacology, therapeutic use)
- Central Nervous System Stimulants
(pharmacology, therapeutic use)
- Combined Modality Therapy
- Female
- Humans
- Infant, Newborn
- Infant, Premature
- Infant, Premature, Diseases
(drug therapy)
- Infant, Very Low Birth Weight
- Logistic Models
- Male
- Oxygen Inhalation Therapy
- Respiration, Artificial
- Weight Gain
(drug effects)
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