Apnea of Prematurity Clinical Trial
Official title:
Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants
Verified date | September 2016 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2000 |
Est. completion date | July 2016 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Days |
Eligibility |
Inclusion Criteria: - birthweight 500 to 1250 grams - postnatal age day 1 to day 10 - infant considered a candidate for methylxanthine therapy by clinical staff Exclusion Criteria: - dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment - unlikely to comply with long-term follow-up - prior treatment with a methylxanthine |
Country | Name | City | State |
---|---|---|---|
Australia | Women's & Children's Hospital | Adelaide | South Australia |
Australia | Canberra Hospital | Canberra | Australian Capital Territory |
Australia | Mercy Hospital for Women | Melbourne | Victoria |
Australia | Royal Women's Hospital | Melbourne | Victoria |
Canada | Foothills Hospital | Calgary | Alberta |
Canada | McMaster University | Hamilton | Ontario |
Canada | Kingston General Hospital | Kingston | Ontario |
Canada | Moncton Hospital | Moncton | New Brunswick |
Canada | Royal Victoria Hospital | Montreal | Quebec |
Canada | Ottawa Hospital | Ottawa | Ontario |
Canada | Centre Hospitalier Universitaire de Quebec | Quebec | |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | University of Sherbrooke | Sherbrooke | Quebec |
Canada | Mount Sinai Hospital | Toronto | Ontario |
Canada | Sunnybrook & Women's College Health Science Centre | Toronto | Ontario |
Canada | Children's & Women's Health Centre of BC | Vancouver | British Columbia |
Canada | Victoria General Hospital | Victoria | British Columbia |
Canada | Windsor Regional Hospital | Windsor | Ontario |
Canada | St. Boniface General Hospital | Winnipeg | Manitoba |
Germany | Ludwig Maximilian University | Munich | |
Germany | University of Tuebingen | Tuebingen | |
Israel | Soroka University Medical Center | Beer Sheva | |
Israel | Meir General Hospital | Kfar-Saba | |
Israel | Kaplan Medical Center | Rehovot | |
Netherlands | Academisch Medisch Centrum | Amsterdam | |
Netherlands | University Hospital Maastricht | Maastricht | |
Sweden | Astrid Lindgren's Children's Hospital | Stockholm | |
Switzerland | University Children's Hospital Basel | Basel | |
Switzerland | University Hospitals of Geneve | Geneva | |
Switzerland | University of Zurich | Zurich | |
United Kingdom | Royal Maternity Hospital | Belfast | Northern Ireland |
United Kingdom | South Cleveland Hospital | Middlesbrough | |
United Kingdom | Royal Victoria Infirmary | Newcastle-upon-Tyne | |
United States | Brooklyn Hospital Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), National Health and Medical Research Council, Australia |
United States, Australia, Canada, Germany, Israel, Netherlands, Sweden, Switzerland, United Kingdom,
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 — View Citation
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 Pe — View Citation
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: 10.15 — View Citation
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 afte — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. | corrected age of 18 months | ||
Secondary | bronchopulmonary dysplasia | discharge home | ||
Secondary | necrotizing enterocolitis | discharge home | ||
Secondary | brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly | discharge home | ||
Secondary | retinopathy of prematurity | discharge home | ||
Secondary | growth failure | corrected age of 18 months | ||
Secondary | functional status at 5 years and at 11-12 years | corrected age of 5 years and chronological age of 11-12 years |
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