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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN44364365 | Registry Identifier | Current Controlled Trials | |
| MCT-13288 | Other Grant/Funding Number | CIHR | |
| MOP-102601 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
| National Health and Medical Research Council, Australia | OTHER |
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At least 5 of every 1000 live-born babies are very premature and weigh only 500 to 1250 grams at birth. Approximately 30-40% of these high-risk infants either die or survive with lasting disabilities. The aim of this research is to reduce this heavy burden of illness. A multi-center randomized controlled trial has been designed in which 2000 very low birth weight infants will be enrolled. Our goal is to determine whether the avoidance of methylxanthine drugs will improve survival without disability to 18 months, corrected for prematurity.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caffeine citrate injection | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. | corrected age of 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| bronchopulmonary dysplasia | discharge home | |
| necrotizing enterocolitis | discharge home | |
| brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara K Schmidt, MD | McMaster University | Study Chair |
| Robin S Roberts, MTech | McMaster University | Study Director |
| Peter Davis, MD | Royal Women's Hospital, Melbourne, Australia | Study Director |
| Lex Doyle, MD | Royal Women's Hospital, Melbourne, Australia | Study Director |
| Arne Ohlsson, MD | Mount Sinai Hospital, Canada | Study Director |
| Alfonso Solimano, MD | Children & Women's Health Centre of BC, Vancouver, Canada | Study Director |
| Win Tin, MD | James Cook University Hospital, Middlesbrough, UK | Study Director |
| Keith J Barrington, MD | Royal Victoria Hospital/McGill University, Montreal, Canada | Study Director |
| Elizabeth Asztalos, MD | Sunnybrook Health Sciences Centre, Toronto, Canada | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooklyn Hospital Center | Brooklyn | New York | 11201 | United States | ||
| Canberra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16707748 | Result | 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. | |
| 17989382 | Result | 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. |
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| discharge home |
| retinopathy of prematurity | discharge home |
| growth failure | corrected age of 18 months |
| functional status at 5 years and at 11-12 years | corrected age of 5 years and chronological age of 11-12 years |
| Deborah Dewey, MD | University of Calgary, Alberta, Canada | Study Director |
| Ruth Grunau, MD | University of British Columbia, Vancouver, Canada | Study Director |
| Diane Moddemann, MD | University of Manitoba, Winnipeg, Canada | Study Director |
| Peter Anderson, PhD | University of Melbourne, Australia | Study Director |
| Canberra |
| Australian Capital Territory |
| 2605 |
| Australia |
| Women's & Children's Hospital | Adelaide | South Australia | 5006 | Australia |
| Mercy Hospital for Women | Melbourne | Victoria | 3002 | Australia |
| Royal Women's Hospital | Melbourne | Victoria | 3053 | Australia |
| Foothills Hospital | Calgary | Alberta | T2N 4N1 | Canada |
| Children's & Women's Health Centre of BC | Vancouver | British Columbia | V6H 3V4 | Canada |
| Victoria General Hospital | Victoria | British Columbia | V8Z 6R5 | Canada |
| St. Boniface General Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
| Moncton Hospital | Moncton | New Brunswick | E1C 6Z8 | Canada |
| McMaster University | Hamilton | Ontario | L8S 4J9 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Sunnybrook & Women's College Health Science Centre | Toronto | Ontario | M5S 1B2 | Canada |
| Windsor Regional Hospital | Windsor | Ontario | N8W 1L9 | Canada |
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada |
| University of Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Centre Hospitalier Universitaire de Quebec | Québec | G1L 3L5 | Canada |
| Ludwig Maximilian University | Munich | 81377 | Germany |
| University of Tuebingen | Tübingen | D-72076 | Germany |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Meir General Hospital | Kfar Saba | 44281 | Israel |
| Kaplan Medical Center | Rehovot | Israel |
| Academisch Medisch Centrum | Amsterdam | 1100 DD | Netherlands |
| University Hospital Maastricht | Maastricht | Netherlands |
| Astrid Lindgren's Children's Hospital | Stockholm | SE-17176 | Sweden |
| University Children's Hospital Basel | Basel | CH-4005 | Switzerland |
| University Hospitals of Geneve | Geneva | 1211 | Switzerland |
| University of Zurich | Zurich | CH-8091 | Switzerland |
| Royal Maternity Hospital | Belfast | Northern Ireland | BT12 6BB | United Kingdom |
| South Cleveland Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| Royal Victoria Infirmary | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| 19926098 | Result | 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. |
| 22253394 | Result | 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. |
| 21173002 | Result | 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. |
| 24496539 | Result | 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. |
| 24840756 | Result | 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. |
| 28707987 | Derived | 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. |
| 28437520 | Derived | 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. |
| 25784749 | Derived | 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. |
| 25641237 | Derived | 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. |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D002658 | Developmental Disabilities |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C026189 | caffeine citrate |
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