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Barbara Schmidt - One of the best experts on this subject based on the ideXlab platform.
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Neurobehavioral Outcomes 11 Years After Neonatal Caffeine Therapy for Apnea of Prematurity.
Pediatrics, 2018Co-Authors: Ines M. Mürner-lavanchy, Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Elizabeth Asztalos, Lorrie Costantini, Deborah Dewey, Judy D'ilario, Ruth E. GrunauAbstract:BACKGROUND AND OBJECTIVES: Caffeine is effective in the treatment of Apnea of Prematurity. Although caffeine therapy has a benefit on gross motor skills in school-aged children, effects on neurobehavioral outcomes are not fully understood. We aimed to investigate effects of neonatal caffeine therapy in very low birth weight (500–1250 g) infants on neurobehavioral outcomes in 11-year-old participants of the Caffeine for Apnea of Prematurity trial. METHODS: Thirteen academic hospitals in Canada, Australia, Great Britain, and Sweden participated in this part of the 11-year follow-up of the double-blind, randomized, placebo-controlled trial. Measures of general intelligence, attention, executive function, visuomotor integration and perception, and behavior were obtained in up to 870 children. The effects of caffeine therapy were assessed by using regression models. RESULTS: Neurobehavioral outcomes were generally similar for both the caffeine and placebo group. The caffeine group performed better than the placebo group in fine motor coordination (mean difference [MD] = 2.9; 95% confidence interval [CI]: 0.7 to 5.1; P = .01), visuomotor integration (MD = 1.8; 95% CI: 0.0 to 3.7; P P = .02), and visuospatial organization (MD = 1.2; 95% CI: 0.4 to 2.0; P = .003). CONCLUSIONS: Neonatal caffeine therapy for Apnea of Prematurity improved visuomotor, visuoperceptual, and visuospatial abilities at age 11 years. General intelligence, attention, and behavior were not adversely affected by caffeine, which highlights the long-term safety of caffeine therapy for Apnea of Prematurity in very low birth weight neonates.
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survival without disability to age 5 years after neonatal caffeine therapy for Apnea of Prematurity
JAMA, 2012Co-Authors: Barbara Schmidt, Lex W. Doyle, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Peter G DavisAbstract:Context Very preterm infants are prone to Apnea and have an increased risk of death or disability. Caffeine therapy for Apnea of Prematurity reduces the rates of cerebral palsy and cognitive delay at 18 months of age. Objective To determine whether neonatal caffeine therapy has lasting benefits or newly apparent risks at early school age. Design, Setting, and Participants Five-year follow-up from 2005 to 2011 in 31 of 35 academic hospitals in Canada, Australia, Europe, and Israel, where 1932 of 2006 participants (96.3%) had been enrolled in the randomized, placebo-controlled Caffeine for Apnea of Prematurity trial between 1999 and 2004. A total of 1640 children (84.9%) with birth weights of 500 to 1250 g had adequate data for the main outcome at 5 years. Main Outcome Measures Combined outcome of death or survival to 5 years with 1 or more of motor impairment (defined as a Gross Motor Function Classification System level of 3 to 5), cognitive impairment (defined as a Full Scale IQ70), behavior problems, poor general health, deafness, and blindness. Results The combined outcome of death or disability was not significantly different for the 833 children assigned to caffeine from that for the 807 children assigned to placebo (21.1% vs 24.8%; odds ratio adjusted for center, 0.82; 95% CI, 0.65-1.03; P=.09). The rates of death, motor impairment, behavior problems, poor general health, deafness, and blindness did not differ significantly between the 2 groups. The incidence of cognitive impairment was lower at 5 years than at 18 months and similar in the 2 groups (4.9% vs 5.1%; odds ratio adjusted for center, 0.97; 95% CI, 0.61-1.55; P=.89). Conclusion Neonatal caffeine therapy was no longer associated with a significantly improved rate of survival without disability in children with very low birth weights who were assessed at 5 years.
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The Caffeine for Apnea of Prematurity (CAP) Trial: Preliminary Outcomes at 5 Years
Pediatric Research, 2011Co-Authors: Barbara Schmidt, Peter G Davis, Lex W. Doyle, Win Tin, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Diane Moddemann, Alfonso SolimanoAbstract:Background: The CAP trial enrolled 2006 infants with birth weights 500-1250 g who were randomly assigned to caffeine therapy or placebo for Apnea of Prematurity (N Engl J Med 2006; 354: 2112 and 2007; 357:1893). Objective: To reassess CAP trial participants at 5 years. Design and methods: The main outcome at 5 years was a composite of death or survival with disability in one of 6 domains including neuromotor function, cognition, behaviour, and general health. Standardized tests included the Gross Motor Function Classification System (GMFCS), the Wechsler Preschool and Primary Scale of Intelligence, and the Child Behavior Checklist Parent Form. Results: A total of 1932 children were eligible for the present study. Vital status was ascertained for 1810 children (94%). Adequate data for the composite outcome of death or disability were available for 1641 children (85%). Table 1 shows the results for the composite outcome and for 5 of its components. Conclusions: Observed rates of functional outcomes at 5 years still favoured caffeine therapy for Apnea of Prematurity over placebo treatment. However, cognitive impairment was no longer reduced in caffeine-treated infants.
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Economic Evaluation of Caffeine for Apnea of Prematurity
Pediatrics, 2010Co-Authors: Dmitry Dukhovny, Barbara Schmidt, Robin S. Roberts, Lex W. Doyle, Scott A. Lorch, Joke H. Kok, Karen Kamholz, Na Wang, Wenyang Mao, John A.f. ZupancicAbstract:OBJECTIVE: To determine the cost-effectiveness of treatment with caffeine compared with placebo for Apnea of Prematurity in infants with birth weights less than 1250 g, from birth through 18 to 21 months9 corrected age. METHODS: We undertook a retrospective economic evaluation of the cost per survivor without neurodevelopmental impairment by using individual-patient data from the Caffeine for Apnea of Prematurity clinical trial (N = 1869). We included direct medical costs either to the insurance payer or the hospital but excluded costs to parents and society, such as lost productivity. We used a price of $0.21/mg of generic caffeine citrate for our base-case analysis. All costs were expressed in 2008 Canadian dollars and discounted at 3%. The time horizon for this analysis extended through 18 to 21 months9 corrected age to match the clinical trial. RESULTS: The mean cost per infant was $124 466 in the caffeine group and $133 505 in the placebo group (difference: $9039 [−14 749 to −3375]; adjusted P = .014). Cost-effectiveness analysis showed caffeine to be a dominant or “win-win” therapy: in >99% of 1000 bootstrap replications of the analysis, caffeine-treated infants had simultaneously better outcomes and lower mean costs. These results were robust to a 1000% increase in the individual resource items, including the price of caffeine citrate. CONCLUSIONS: In comparison with placebo, caffeine therapy for Apnea of Prematurity in infants weighing less than 1250 g is economically appealing for infants up to 18 to 21 months9 corrected age.
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long term effects of caffeine therapy for Apnea of Prematurity
The New England Journal of Medicine, 2007Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win TinAbstract: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.)
Lex W. Doyle - One of the best experts on this subject based on the ideXlab platform.
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Neurobehavioral Outcomes 11 Years After Neonatal Caffeine Therapy for Apnea of Prematurity.
Pediatrics, 2018Co-Authors: Ines M. Mürner-lavanchy, Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Elizabeth Asztalos, Lorrie Costantini, Deborah Dewey, Judy D'ilario, Ruth E. GrunauAbstract:BACKGROUND AND OBJECTIVES: Caffeine is effective in the treatment of Apnea of Prematurity. Although caffeine therapy has a benefit on gross motor skills in school-aged children, effects on neurobehavioral outcomes are not fully understood. We aimed to investigate effects of neonatal caffeine therapy in very low birth weight (500–1250 g) infants on neurobehavioral outcomes in 11-year-old participants of the Caffeine for Apnea of Prematurity trial. METHODS: Thirteen academic hospitals in Canada, Australia, Great Britain, and Sweden participated in this part of the 11-year follow-up of the double-blind, randomized, placebo-controlled trial. Measures of general intelligence, attention, executive function, visuomotor integration and perception, and behavior were obtained in up to 870 children. The effects of caffeine therapy were assessed by using regression models. RESULTS: Neurobehavioral outcomes were generally similar for both the caffeine and placebo group. The caffeine group performed better than the placebo group in fine motor coordination (mean difference [MD] = 2.9; 95% confidence interval [CI]: 0.7 to 5.1; P = .01), visuomotor integration (MD = 1.8; 95% CI: 0.0 to 3.7; P P = .02), and visuospatial organization (MD = 1.2; 95% CI: 0.4 to 2.0; P = .003). CONCLUSIONS: Neonatal caffeine therapy for Apnea of Prematurity improved visuomotor, visuoperceptual, and visuospatial abilities at age 11 years. General intelligence, attention, and behavior were not adversely affected by caffeine, which highlights the long-term safety of caffeine therapy for Apnea of Prematurity in very low birth weight neonates.
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long term effects of caffeine therapy for Apnea of Prematurity on sleep at school age
American Journal of Respiratory and Critical Care Medicine, 2014Co-Authors: Carole L Marcus, Robin S. Roberts, Lex W. Doyle, Elizabeth Asztalos, Lisa J Meltzer, Joel Traylor, Joanne Dix, Judy Dilario, Gillian Opie, Sarah N BiggsAbstract:Rationale: Apnea of Prematurity is a common condition that is usually treated with caffeine, an adenosine receptor blocker that has powerful influences on the central nervous system. However, little is known about the long-term effects of caffeine on sleep in the developing brain.Objectives: We hypothesized that neonatal caffeine use resulted in long-term abnormalities in sleep architecture and breathing during sleep.Methods: A total of 201 ex-preterm children aged 5–12 years who participated as neonates in a double-blind, randomized, controlled clinical trial of caffeine versus placebo underwent actigraphy, polysomnography, and parental sleep questionnaires. Coprimary outcomes were total sleep time on actigraphy and Apnea–hypopnea index on polysomnography.Measurements and Main Results: There were no significant differences in primary outcomes between the caffeine group and the placebo (adjusted mean difference of −6.7 [95% confidence interval (CI) = −15.3 to 2.0 min]; P = 0.13 for actigraphic total sleep...
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survival without disability to age 5 years after neonatal caffeine therapy for Apnea of Prematurity
JAMA, 2012Co-Authors: Barbara Schmidt, Lex W. Doyle, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Peter G DavisAbstract:Context Very preterm infants are prone to Apnea and have an increased risk of death or disability. Caffeine therapy for Apnea of Prematurity reduces the rates of cerebral palsy and cognitive delay at 18 months of age. Objective To determine whether neonatal caffeine therapy has lasting benefits or newly apparent risks at early school age. Design, Setting, and Participants Five-year follow-up from 2005 to 2011 in 31 of 35 academic hospitals in Canada, Australia, Europe, and Israel, where 1932 of 2006 participants (96.3%) had been enrolled in the randomized, placebo-controlled Caffeine for Apnea of Prematurity trial between 1999 and 2004. A total of 1640 children (84.9%) with birth weights of 500 to 1250 g had adequate data for the main outcome at 5 years. Main Outcome Measures Combined outcome of death or survival to 5 years with 1 or more of motor impairment (defined as a Gross Motor Function Classification System level of 3 to 5), cognitive impairment (defined as a Full Scale IQ70), behavior problems, poor general health, deafness, and blindness. Results The combined outcome of death or disability was not significantly different for the 833 children assigned to caffeine from that for the 807 children assigned to placebo (21.1% vs 24.8%; odds ratio adjusted for center, 0.82; 95% CI, 0.65-1.03; P=.09). The rates of death, motor impairment, behavior problems, poor general health, deafness, and blindness did not differ significantly between the 2 groups. The incidence of cognitive impairment was lower at 5 years than at 18 months and similar in the 2 groups (4.9% vs 5.1%; odds ratio adjusted for center, 0.97; 95% CI, 0.61-1.55; P=.89). Conclusion Neonatal caffeine therapy was no longer associated with a significantly improved rate of survival without disability in children with very low birth weights who were assessed at 5 years.
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The Caffeine for Apnea of Prematurity (CAP) Trial: Preliminary Outcomes at 5 Years
Pediatric Research, 2011Co-Authors: Barbara Schmidt, Peter G Davis, Lex W. Doyle, Win Tin, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Diane Moddemann, Alfonso SolimanoAbstract:Background: The CAP trial enrolled 2006 infants with birth weights 500-1250 g who were randomly assigned to caffeine therapy or placebo for Apnea of Prematurity (N Engl J Med 2006; 354: 2112 and 2007; 357:1893). Objective: To reassess CAP trial participants at 5 years. Design and methods: The main outcome at 5 years was a composite of death or survival with disability in one of 6 domains including neuromotor function, cognition, behaviour, and general health. Standardized tests included the Gross Motor Function Classification System (GMFCS), the Wechsler Preschool and Primary Scale of Intelligence, and the Child Behavior Checklist Parent Form. Results: A total of 1932 children were eligible for the present study. Vital status was ascertained for 1810 children (94%). Adequate data for the composite outcome of death or disability were available for 1641 children (85%). Table 1 shows the results for the composite outcome and for 5 of its components. Conclusions: Observed rates of functional outcomes at 5 years still favoured caffeine therapy for Apnea of Prematurity over placebo treatment. However, cognitive impairment was no longer reduced in caffeine-treated infants.
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Economic Evaluation of Caffeine for Apnea of Prematurity
Pediatrics, 2010Co-Authors: Dmitry Dukhovny, Barbara Schmidt, Robin S. Roberts, Lex W. Doyle, Scott A. Lorch, Joke H. Kok, Karen Kamholz, Na Wang, Wenyang Mao, John A.f. ZupancicAbstract:OBJECTIVE: To determine the cost-effectiveness of treatment with caffeine compared with placebo for Apnea of Prematurity in infants with birth weights less than 1250 g, from birth through 18 to 21 months9 corrected age. METHODS: We undertook a retrospective economic evaluation of the cost per survivor without neurodevelopmental impairment by using individual-patient data from the Caffeine for Apnea of Prematurity clinical trial (N = 1869). We included direct medical costs either to the insurance payer or the hospital but excluded costs to parents and society, such as lost productivity. We used a price of $0.21/mg of generic caffeine citrate for our base-case analysis. All costs were expressed in 2008 Canadian dollars and discounted at 3%. The time horizon for this analysis extended through 18 to 21 months9 corrected age to match the clinical trial. RESULTS: The mean cost per infant was $124 466 in the caffeine group and $133 505 in the placebo group (difference: $9039 [−14 749 to −3375]; adjusted P = .014). Cost-effectiveness analysis showed caffeine to be a dominant or “win-win” therapy: in >99% of 1000 bootstrap replications of the analysis, caffeine-treated infants had simultaneously better outcomes and lower mean costs. These results were robust to a 1000% increase in the individual resource items, including the price of caffeine citrate. CONCLUSIONS: In comparison with placebo, caffeine therapy for Apnea of Prematurity in infants weighing less than 1250 g is economically appealing for infants up to 18 to 21 months9 corrected age.
Peter G Davis - One of the best experts on this subject based on the ideXlab platform.
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Neurobehavioral Outcomes 11 Years After Neonatal Caffeine Therapy for Apnea of Prematurity.
Pediatrics, 2018Co-Authors: Ines M. Mürner-lavanchy, Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Elizabeth Asztalos, Lorrie Costantini, Deborah Dewey, Judy D'ilario, Ruth E. GrunauAbstract:BACKGROUND AND OBJECTIVES: Caffeine is effective in the treatment of Apnea of Prematurity. Although caffeine therapy has a benefit on gross motor skills in school-aged children, effects on neurobehavioral outcomes are not fully understood. We aimed to investigate effects of neonatal caffeine therapy in very low birth weight (500–1250 g) infants on neurobehavioral outcomes in 11-year-old participants of the Caffeine for Apnea of Prematurity trial. METHODS: Thirteen academic hospitals in Canada, Australia, Great Britain, and Sweden participated in this part of the 11-year follow-up of the double-blind, randomized, placebo-controlled trial. Measures of general intelligence, attention, executive function, visuomotor integration and perception, and behavior were obtained in up to 870 children. The effects of caffeine therapy were assessed by using regression models. RESULTS: Neurobehavioral outcomes were generally similar for both the caffeine and placebo group. The caffeine group performed better than the placebo group in fine motor coordination (mean difference [MD] = 2.9; 95% confidence interval [CI]: 0.7 to 5.1; P = .01), visuomotor integration (MD = 1.8; 95% CI: 0.0 to 3.7; P P = .02), and visuospatial organization (MD = 1.2; 95% CI: 0.4 to 2.0; P = .003). CONCLUSIONS: Neonatal caffeine therapy for Apnea of Prematurity improved visuomotor, visuoperceptual, and visuospatial abilities at age 11 years. General intelligence, attention, and behavior were not adversely affected by caffeine, which highlights the long-term safety of caffeine therapy for Apnea of Prematurity in very low birth weight neonates.
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Methylxanthine use for Apnea of Prematurity among an international cohort of neonatologists
Journal of neonatal-perinatal medicine, 2013Co-Authors: E. G. Abu Jawdeh, Khalid Yunis, Peter G Davis, M. O'riordan, A. Limrungsikul, A. Bandyopadhyay, B.m. Argus, P.e. Nakad, S. Supapannachart, Richard J. MartinAbstract:BACKGROUND A recent multinational clinical trial in preterm infants has demonstrated pulmonary and neurodevelopmental benefits from caffeine therapy. Indications for caffeine use in that study were predominantly for treatment of Apnea and facilitation of extubation rather than prophylaxis. There are no recent studies that describe current practice of neonatologists and regional differences in regards to indications for starting, monitoring and discontinuing methylxanthine therapy in premature infants. OBJECTIVE To characterize the spectrum of current practice and demonstrate the extent to which methylxanthine therapy varies by location. METHODS A cross-sectional survey of all neonatologists in Thailand, Lebanon, Australia, and a representative sample in the USA regarding management of Apnea of Prematurity. RESULTS The response rate was 50% (342/681). The methylxanthine of choice varied greatly across study locations. Prophylactic methylxanthine use is common (62%) among neonatologists in all four study locations. Significant variation exists in almost all aspects of Apnea pharmacotherapy practice among neonatologists in different international locations. CONCLUSIONS Prophylactic use of methylxanthine therapy for Apnea of Prematurity is widespread. We speculate that this expanded use is possibly attributed to the beneficial effects of caffeine therapy in the Caffeine for Apnea of Prematurity (CAP) Trial.
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survival without disability to age 5 years after neonatal caffeine therapy for Apnea of Prematurity
JAMA, 2012Co-Authors: Barbara Schmidt, Lex W. Doyle, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Peter G DavisAbstract:Context Very preterm infants are prone to Apnea and have an increased risk of death or disability. Caffeine therapy for Apnea of Prematurity reduces the rates of cerebral palsy and cognitive delay at 18 months of age. Objective To determine whether neonatal caffeine therapy has lasting benefits or newly apparent risks at early school age. Design, Setting, and Participants Five-year follow-up from 2005 to 2011 in 31 of 35 academic hospitals in Canada, Australia, Europe, and Israel, where 1932 of 2006 participants (96.3%) had been enrolled in the randomized, placebo-controlled Caffeine for Apnea of Prematurity trial between 1999 and 2004. A total of 1640 children (84.9%) with birth weights of 500 to 1250 g had adequate data for the main outcome at 5 years. Main Outcome Measures Combined outcome of death or survival to 5 years with 1 or more of motor impairment (defined as a Gross Motor Function Classification System level of 3 to 5), cognitive impairment (defined as a Full Scale IQ70), behavior problems, poor general health, deafness, and blindness. Results The combined outcome of death or disability was not significantly different for the 833 children assigned to caffeine from that for the 807 children assigned to placebo (21.1% vs 24.8%; odds ratio adjusted for center, 0.82; 95% CI, 0.65-1.03; P=.09). The rates of death, motor impairment, behavior problems, poor general health, deafness, and blindness did not differ significantly between the 2 groups. The incidence of cognitive impairment was lower at 5 years than at 18 months and similar in the 2 groups (4.9% vs 5.1%; odds ratio adjusted for center, 0.97; 95% CI, 0.61-1.55; P=.89). Conclusion Neonatal caffeine therapy was no longer associated with a significantly improved rate of survival without disability in children with very low birth weights who were assessed at 5 years.
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The Caffeine for Apnea of Prematurity (CAP) Trial: Preliminary Outcomes at 5 Years
Pediatric Research, 2011Co-Authors: Barbara Schmidt, Peter G Davis, Lex W. Doyle, Win Tin, Elizabeth Asztalos, Deborah Dewey, Ruth E. Grunau, Peter J. Anderson, Diane Moddemann, Alfonso SolimanoAbstract:Background: The CAP trial enrolled 2006 infants with birth weights 500-1250 g who were randomly assigned to caffeine therapy or placebo for Apnea of Prematurity (N Engl J Med 2006; 354: 2112 and 2007; 357:1893). Objective: To reassess CAP trial participants at 5 years. Design and methods: The main outcome at 5 years was a composite of death or survival with disability in one of 6 domains including neuromotor function, cognition, behaviour, and general health. Standardized tests included the Gross Motor Function Classification System (GMFCS), the Wechsler Preschool and Primary Scale of Intelligence, and the Child Behavior Checklist Parent Form. Results: A total of 1932 children were eligible for the present study. Vital status was ascertained for 1810 children (94%). Adequate data for the composite outcome of death or disability were available for 1641 children (85%). Table 1 shows the results for the composite outcome and for 5 of its components. Conclusions: Observed rates of functional outcomes at 5 years still favoured caffeine therapy for Apnea of Prematurity over placebo treatment. However, cognitive impairment was no longer reduced in caffeine-treated infants.
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long term effects of caffeine therapy for Apnea of Prematurity
The New England Journal of Medicine, 2007Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win TinAbstract: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.)
Robin S. Roberts - One of the best experts on this subject based on the ideXlab platform.
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Neurobehavioral Outcomes 11 Years After Neonatal Caffeine Therapy for Apnea of Prematurity.
Pediatrics, 2018Co-Authors: Ines M. Mürner-lavanchy, Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Elizabeth Asztalos, Lorrie Costantini, Deborah Dewey, Judy D'ilario, Ruth E. GrunauAbstract:BACKGROUND AND OBJECTIVES: Caffeine is effective in the treatment of Apnea of Prematurity. Although caffeine therapy has a benefit on gross motor skills in school-aged children, effects on neurobehavioral outcomes are not fully understood. We aimed to investigate effects of neonatal caffeine therapy in very low birth weight (500–1250 g) infants on neurobehavioral outcomes in 11-year-old participants of the Caffeine for Apnea of Prematurity trial. METHODS: Thirteen academic hospitals in Canada, Australia, Great Britain, and Sweden participated in this part of the 11-year follow-up of the double-blind, randomized, placebo-controlled trial. Measures of general intelligence, attention, executive function, visuomotor integration and perception, and behavior were obtained in up to 870 children. The effects of caffeine therapy were assessed by using regression models. RESULTS: Neurobehavioral outcomes were generally similar for both the caffeine and placebo group. The caffeine group performed better than the placebo group in fine motor coordination (mean difference [MD] = 2.9; 95% confidence interval [CI]: 0.7 to 5.1; P = .01), visuomotor integration (MD = 1.8; 95% CI: 0.0 to 3.7; P P = .02), and visuospatial organization (MD = 1.2; 95% CI: 0.4 to 2.0; P = .003). CONCLUSIONS: Neonatal caffeine therapy for Apnea of Prematurity improved visuomotor, visuoperceptual, and visuospatial abilities at age 11 years. General intelligence, attention, and behavior were not adversely affected by caffeine, which highlights the long-term safety of caffeine therapy for Apnea of Prematurity in very low birth weight neonates.
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long term effects of caffeine therapy for Apnea of Prematurity on sleep at school age
American Journal of Respiratory and Critical Care Medicine, 2014Co-Authors: Carole L Marcus, Robin S. Roberts, Lex W. Doyle, Elizabeth Asztalos, Lisa J Meltzer, Joel Traylor, Joanne Dix, Judy Dilario, Gillian Opie, Sarah N BiggsAbstract:Rationale: Apnea of Prematurity is a common condition that is usually treated with caffeine, an adenosine receptor blocker that has powerful influences on the central nervous system. However, little is known about the long-term effects of caffeine on sleep in the developing brain.Objectives: We hypothesized that neonatal caffeine use resulted in long-term abnormalities in sleep architecture and breathing during sleep.Methods: A total of 201 ex-preterm children aged 5–12 years who participated as neonates in a double-blind, randomized, controlled clinical trial of caffeine versus placebo underwent actigraphy, polysomnography, and parental sleep questionnaires. Coprimary outcomes were total sleep time on actigraphy and Apnea–hypopnea index on polysomnography.Measurements and Main Results: There were no significant differences in primary outcomes between the caffeine group and the placebo (adjusted mean difference of −6.7 [95% confidence interval (CI) = −15.3 to 2.0 min]; P = 0.13 for actigraphic total sleep...
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Economic Evaluation of Caffeine for Apnea of Prematurity
Pediatrics, 2010Co-Authors: Dmitry Dukhovny, Barbara Schmidt, Robin S. Roberts, Lex W. Doyle, Scott A. Lorch, Joke H. Kok, Karen Kamholz, Na Wang, Wenyang Mao, John A.f. ZupancicAbstract:OBJECTIVE: To determine the cost-effectiveness of treatment with caffeine compared with placebo for Apnea of Prematurity in infants with birth weights less than 1250 g, from birth through 18 to 21 months9 corrected age. METHODS: We undertook a retrospective economic evaluation of the cost per survivor without neurodevelopmental impairment by using individual-patient data from the Caffeine for Apnea of Prematurity clinical trial (N = 1869). We included direct medical costs either to the insurance payer or the hospital but excluded costs to parents and society, such as lost productivity. We used a price of $0.21/mg of generic caffeine citrate for our base-case analysis. All costs were expressed in 2008 Canadian dollars and discounted at 3%. The time horizon for this analysis extended through 18 to 21 months9 corrected age to match the clinical trial. RESULTS: The mean cost per infant was $124 466 in the caffeine group and $133 505 in the placebo group (difference: $9039 [−14 749 to −3375]; adjusted P = .014). Cost-effectiveness analysis showed caffeine to be a dominant or “win-win” therapy: in >99% of 1000 bootstrap replications of the analysis, caffeine-treated infants had simultaneously better outcomes and lower mean costs. These results were robust to a 1000% increase in the individual resource items, including the price of caffeine citrate. CONCLUSIONS: In comparison with placebo, caffeine therapy for Apnea of Prematurity in infants weighing less than 1250 g is economically appealing for infants up to 18 to 21 months9 corrected age.
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long term effects of caffeine therapy for Apnea of Prematurity
The New England Journal of Medicine, 2007Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win TinAbstract: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.)
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Caffeine Therapy for Apnea of Prematurity
The New England journal of medicine, 2006Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win Tin, Abstr ActAbstract: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
Keith J. Barrington - One of the best experts on this subject based on the ideXlab platform.
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long term effects of caffeine therapy for Apnea of Prematurity
The New England Journal of Medicine, 2007Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win TinAbstract: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.)
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Caffeine Therapy for Apnea of Prematurity
The New England journal of medicine, 2006Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win Tin, Abstr ActAbstract: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
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caffeine therapy for Apnea of Prematurity
The New England Journal of Medicine, 2006Co-Authors: Barbara Schmidt, Robin S. Roberts, Peter G Davis, Lex W. Doyle, Keith J. Barrington, Arne Ohlsson, Alfonso Solimano, Win Tin, Abstr ActAbstract: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.)
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role of l carnitine in Apnea of Prematurity a randomized controlled trial
Pediatrics, 2002Co-Authors: Jane Odonnell, Neil N Finer, Wade Rich, Bruce Barshop, Keith J. BarringtonAbstract:OBJECTIVE Carnitine is thought to be a conditionally essential biological cofactor for premature infants. A preliminary study suggested that carnitine could significantly reduce Apnea of Prematurity. The objective of this study was to evaluate critically the role of carnitine in idiopathic Apnea of Prematurity and to determine whether the use of carnitine would facilitate discontinuation of mechanical ventilatory support, shorten the duration of ventilatory support, and reduce the amount of time that such infants are exposed to both mechanical ventilation and oxygen. We also wanted to determine the effects of supplemental carnitine on weight gain, time to regain birth weight, time to achieve full enteral feedings, and length of hospital stay. METHODS A prospective, randomized, blinded trial was conducted on 44 preterm infants who were from the same neonatal intensive care unit and who were < or =32 weeks' gestational age with a postnatal age <48 hours and a birth weight <1500 g and required total parenteral nutrition (TPN). Infants were randomized to receive carnitine supplementation or placebo without crossover. Carnitine-supplemented infants received 30 mg/kg/d carnitine in their TPN until the they were tolerating 120 mL/kg/d enteral feedings, and then they received 30 mg/kg/d oral carnitine. The placebo group received TPN without supplemental carnitine; when they tolerated 120 mL/kg/d enteral feedings, they received an oral placebo. The 2 groups continued on their respective supplemental carnitine or placebo until 34 weeks' adjusted age, at which time the study period was completed. Twelve-hour cardiorespiratorygrams to record heart rate, respiratory impedance, and oxygen saturation, and a nasal thermistor to detect expiratory airflow were performed every 4 days on 3 occasions and at 30 and 34 weeks' adjusted age. Plasma carnitine levels were measured at day 14. RESULTS There were no significant differences between the 2 groups in the occurrence of Apnea as detected by cardiorespiratorygram or nursing observation. There were no significant differences between the groups in regard to total days on ventilator, days of nasal continuous positive airway pressure, time to regain birth weight, time to reach enteral feedings of 120 mL/kg/d, discharge weight, adjusted age at discharge, need for oxygen at 28 days' and 36 weeks' adjusted age, or length of stay. The plasma carnitine level was a median of 15.5 micromol/L (range: 7.6-30.5) for the placebo infants compared with a median of 195.3 micromol/L (range: 71.7-343.6) for the carnitine infants. CONCLUSIONS In this blinded, randomized, placebo-controlled study, we found that infants who received supplemental carnitine did not demonstrate any reduction in Apnea of Prematurity, ventilator or nasal continuous positive airway pressure days, or the need for supplemental oxygen therapy. Although carnitine may be of significant nutritional benefit for very low birth weight infants, our study does not support its use to reduce Apnea of Prematurity or decrease dependence on mechanical ventilation.