Abstract | STUDY OBJECTIVE: DESIGN: Multicenter, parallel, randomized, double-blind, placebo-controlled trial with open-label rescue. SETTING: Nine neonatal intensive care units. PATIENTS: Eighty-five infants, 28-32 weeks postconception and 24 hours or more after birth who had six or more apnea episodes within 24 hours. INTERVENTION:
Caffeine citrate 10 mg/kg (as caffeine base) administered intravenously, followed by 2.5 mg/kg/day orally or intravenously, or placebo, for up to 10 days. Infants failing double-blind therapy could receive open-label rescue. MEASUREMENTS AND MAIN RESULTS: Success was defined as 50% or greater reduction in apnea episodes and elimination of apnea. Caffeine citrate was significantly more effective than placebo in reducing apnea episodes by at least 50% in 6 days (p<0.05), and approached statistical significance (p<0.10) in 3 days. It was significantly better than placebo in eliminating apnea in 5 days (p<0.05), and approached significance (p<0.10) in 2 days. The number of infants with an aggregate of 7-10 days of at least a 50% reduction in apnea events or elimination of apnea was significantly higher in the caffeine citrate than in the placebo group. Adverse events did not differ significantly between groups. No correlations were found between success and mean daily plasma concentrations or baseline characteristics. Volume of distribution and clearance increased with weight, supporting weight-adjusted dosing of caffeine citrate. CONCLUSION:
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Authors | A Erenberg, R D Leff, D G Haack, K W Mosdell, G M Hicks, B A Wynne |
Journal | Pharmacotherapy
(Pharmacotherapy)
Vol. 20
Issue 6
Pg. 644-52
(Jun 2000)
ISSN: 0277-0008 [Print] United States |
PMID | 10853619
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Citrates
- Drug Combinations
- Caffeine
- caffeine citrate
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Topics |
- Apnea
(drug therapy)
- Caffeine
(adverse effects, pharmacokinetics, therapeutic use)
- Citrates
(adverse effects, pharmacokinetics, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Humans
- Infant
- Infant, Newborn
- Male
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