Caffeine for Apnea of Prematurity (CAP)
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants |
- combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. [ Time Frame: corrected age of 18 months ] [ Designated as safety issue: Yes ]
- bronchopulmonary dysplasia [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
- necrotizing enterocolitis [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
- brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
- retinopathy of prematurity [ Time Frame: discharge home ] [ Designated as safety issue: Yes ]
- growth failure [ Time Frame: corrected age of 18 months ] [ Designated as safety issue: Yes ]
- functional status at 5 years and at 11-12 years [ Time Frame: corrected age of 5 years and chronological age of 11-12 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | October 1999 |
| Estimated Study Completion Date: | July 2016 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
-
Drug: 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.
Eligibility| Ages Eligible for Study: | up to 10 Days (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00182312
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, 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: | 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 |
More Information
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Barbara Schmidt, Principal Investigator, McMaster University |
| ClinicalTrials.gov Identifier: | NCT00182312 History of Changes |
| Other Study ID Numbers: | CTMG-1999-CAP ISRCTN44364365 MCT-13288 MOP-102601 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 4, 2014 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McMaster University:
|
preterm infants very low birthweight apnea of prematurity methylxanthines developmental disabilities |
Additional relevant MeSH terms:
|
Apnea Premature Birth Birth Weight Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications Body Weight |
Caffeine Caffeine citrate Central Nervous System Stimulants Physiological Effects of Drugs Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on September 23, 2016