Study Results
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Basic Information
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COMPLETED
PHASE3
2000 participants
INTERVENTIONAL
1999-10-31
2016-07-31
Brief Summary
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Methylxanthine drugs such as caffeine are used to prevent or treat periodic breathing and breath-holding spells in premature infants. However, there is a striking lack of evidence for the long-term efficacy and safety of this therapy. Methylxanthines block a naturally occurring substance, called adenosine, which protects the brain during episodes of oxygen deficiency. Such episodes are common in infants who are treated with methylxanthines. It is possible that methylxanthines may worsen the damage caused by lack of oxygen. Therefore, this trial will clarify whether methylxanthines cause more good than harm in very low birth weight infants.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Interventions
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Caffeine citrate injection
Loading dose: 20 mg/kg administered over at least 30 minutes via IV infusion or over at least 10 minutes via slow IV injection.
Daily maintenance dose (to commence at least 24 hours after loading dose): 5 mg/kg, administered over at least 10 minutes via IV infusion, or over at least 5 minutes via slow IV injection. Maintenance dose to be adjusted for body weight every 7 days. If indicated, maintenance dose may be increased to a maximum of 10 mg/kg. May be given orally once full enteral feeds are established.
Duration of treatment: discontinue after infant has tolerated at least 5 consecutive days without positive pressure support AND when the infant is judged by the attending clinician to be no longer a candidate for methylxanthine therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* postnatal age day 1 to day 10
* infant considered a candidate for methylxanthine therapy by clinical staff
Exclusion Criteria
* unlikely to comply with long-term follow-up
* prior treatment with a methylxanthine
10 Days
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
National Health and Medical Research Council, Australia
OTHER
McMaster University
OTHER
Responsible Party
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Principal Investigators
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Barbara K Schmidt, MD
Role: STUDY_CHAIR
McMaster University
Robin S Roberts, MTech
Role: STUDY_DIRECTOR
McMaster University
Peter Davis, MD
Role: STUDY_DIRECTOR
Royal Women's Hospital, Melbourne, Australia
Lex Doyle, MD
Role: STUDY_DIRECTOR
Royal Women's Hospital, Melbourne, Australia
Arne Ohlsson, MD
Role: STUDY_DIRECTOR
Mount Sinai Hospital, Canada
Alfonso Solimano, MD
Role: STUDY_DIRECTOR
Children & Women's Health Centre of BC, Vancouver, Canada
Win Tin, MD
Role: STUDY_DIRECTOR
James Cook University Hospital, Middlesbrough, UK
Keith J Barrington, MD
Role: STUDY_DIRECTOR
Royal Victoria Hospital/McGill University, Montreal, Canada
Elizabeth Asztalos, MD
Role: STUDY_DIRECTOR
Sunnybrook Health Sciences Centre, Toronto, Canada
Deborah Dewey, MD
Role: STUDY_DIRECTOR
University of Calgary, Alberta, Canada
Ruth Grunau, MD
Role: STUDY_DIRECTOR
University of British Columbia, Vancouver, Canada
Diane Moddemann, MD
Role: STUDY_DIRECTOR
University of Manitoba, Winnipeg, Canada
Peter Anderson, PhD
Role: STUDY_DIRECTOR
University of Melbourne, Australia
Locations
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Brooklyn Hospital Center
Brooklyn, New York, United States
Canberra Hospital
Canberra, Australian Capital Territory, Australia
Women's & Children's Hospital
Adelaide, South Australia, Australia
Mercy Hospital for Women
Melbourne, Victoria, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
Foothills Hospital
Calgary, Alberta, Canada
Children's & Women's Health Centre of BC
Vancouver, British Columbia, Canada
Victoria General Hospital
Victoria, British Columbia, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Moncton Hospital
Moncton, New Brunswick, Canada
McMaster University
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada
Ottawa Hospital
Ottawa, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Sunnybrook & Women's College Health Science Centre
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Royal Victoria Hospital
Montreal, Quebec, Canada
University of Sherbrooke
Sherbrooke, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Universitaire de Quebec
Québec, , Canada
Ludwig Maximilian University
Munich, , Germany
University of Tuebingen
Tübingen, , Germany
Soroka University Medical Center
Beersheba, , Israel
Meir General Hospital
Kfar Saba, , Israel
Kaplan Medical Center
Rehovot, , Israel
Academisch Medisch Centrum
Amsterdam, , Netherlands
University Hospital Maastricht
Maastricht, , Netherlands
Astrid Lindgren's Children's Hospital
Stockholm, , Sweden
University Children's Hospital Basel
Basel, , Switzerland
University Hospitals of Geneve
Geneva, , Switzerland
University of Zurich
Zurich, , Switzerland
Royal Maternity Hospital
Belfast, Northern Ireland, United Kingdom
South Cleveland Hospital
Middlesbrough, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine therapy for apnea of prematurity. N Engl J Med. 2006 May 18;354(20):2112-21. doi: 10.1056/NEJMoa054065.
Schmidt B, Roberts RS, Davis P, Doyle LW, Barrington KJ, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity Trial Group. Long-term effects of caffeine therapy for apnea of prematurity. N Engl J Med. 2007 Nov 8;357(19):1893-902. doi: 10.1056/NEJMoa073679.
Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18.
Schmidt B, Anderson PJ, Doyle LW, Dewey D, Grunau RE, Asztalos EV, Davis PG, Tin W, Moddemann D, Solimano A, Ohlsson A, Barrington KJ, Roberts RS; Caffeine for Apnea of Prematurity (CAP) Trial Investigators. Survival without disability to age 5 years after neonatal caffeine therapy for apnea of prematurity. JAMA. 2012 Jan 18;307(3):275-82. doi: 10.1001/jama.2011.2024.
Dukhovny D, Lorch SA, Schmidt B, Doyle LW, Kok JH, Roberts RS, Kamholz KL, Wang N, Mao W, Zupancic JA; Caffeine for Apnea of Prematurity Trial Group. Economic evaluation of caffeine for apnea of prematurity. Pediatrics. 2011 Jan;127(1):e146-55. doi: 10.1542/peds.2010-1014. Epub 2010 Dec 20.
Schmidt B, Davis PG, Asztalos EV, Solimano A, Roberts RS. Association between severe retinopathy of prematurity and nonvisual disabilities at age 5 years. JAMA. 2014 Feb 5;311(5):523-5. doi: 10.1001/jama.2013.282153. No abstract available.
Doyle LW, Schmidt B, Anderson PJ, Davis PG, Moddemann D, Grunau RE, O'Brien K, Sankaran K, Herlenius E, Roberts R; Caffeine for Apnea of Prematurity Trial investigators. Reduction in developmental coordination disorder with neonatal caffeine therapy. J Pediatr. 2014 Aug;165(2):356-359.e2. doi: 10.1016/j.jpeds.2014.04.016. Epub 2014 May 17.
Doyle LW, Ranganathan S, Cheong JLY. Neonatal Caffeine Treatment and Respiratory Function at 11 Years in Children under 1,251 g at Birth. Am J Respir Crit Care Med. 2017 Nov 15;196(10):1318-1324. doi: 10.1164/rccm.201704-0767OC.
Schmidt B, Roberts RS, Anderson PJ, Asztalos EV, Costantini L, Davis PG, Dewey D, D'Ilario J, Doyle LW, Grunau RE, Moddemann D, Nelson H, Ohlsson A, Solimano A, Tin W; Caffeine for Apnea of Prematurity (CAP) Trial Group. Academic Performance, Motor Function, and Behavior 11 Years After Neonatal Caffeine Citrate Therapy for Apnea of Prematurity: An 11-Year Follow-up of the CAP Randomized Clinical Trial. JAMA Pediatr. 2017 Jun 1;171(6):564-572. doi: 10.1001/jamapediatrics.2017.0238.
Synnes A, Anderson PJ, Grunau RE, Dewey D, Moddemann D, Tin W, Davis PG, Doyle LW, Foster G, Khairy M, Nwaesei C, Schmidt B; CAP Trial Investigator group. Predicting severe motor impairment in preterm children at age 5 years. Arch Dis Child. 2015 Aug;100(8):748-53. doi: 10.1136/archdischild-2014-307695. Epub 2015 Mar 17.
Manley BJ, Roberts RS, Doyle LW, Schmidt B, Anderson PJ, Barrington KJ, Bohm B, Golan A, van Wassenaer-Leemhuis AG, Davis PG; Caffeine for Apnea of Prematurity (CAP) Trial Investigators; Caffeine for Apnea of Prematurity CAP Trial Investigators. Social variables predict gains in cognitive scores across the preschool years in children with birth weights 500 to 1250 grams. J Pediatr. 2015 Apr;166(4):870-6.e1-2. doi: 10.1016/j.jpeds.2014.12.016. Epub 2015 Jan 29.
Other Identifiers
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ISRCTN44364365
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCT-13288
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MOP-102601
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CTMG-1999-CAP
Identifier Type: -
Identifier Source: org_study_id
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