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| Sponsors and Collaborators: |
Hamilton Health Sciences Canadian Institutes of Health Research (CIHR) National Health and Medical Research Council, Australia |
|---|---|
| Information provided by: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00182312 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Apnea of Prematurity |
Drug: Caffeine citrate injection |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants |
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | January 2010 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 10 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 34 Study Locations| Study Chair: | Barbara K Schmidt, MD | McMaster University |
| Study Director: | 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, Toronto, 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 |
More Information
| Responsible Party: | McMaster University ( Barbara Schmidt/Nominated PI ) |
| Study ID Numbers: | CTMG-1999-CAP, ISRCTN44364365, CIHR MCT-13288 |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00182312 |
| Health Authority: | Canada: Health Canada |
|
preterm infants very low birthweight apnea of prematurity methylxanthines |
|
Caffeine citrate Birth Weight Signs and Symptoms Respiratory Tract Diseases Apnea |
Citric Acid Respiration Disorders Signs and Symptoms, Respiratory Caffeine |
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