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Caffeine for Apnea of Prematurity (CAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00182312
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : March 22, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
McMaster University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Apnea of Prematurity Drug: Caffeine citrate injection Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants
Study Start Date : October 1999
Actual Primary Completion Date : March 2007
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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.

    Other Name: CafCit

Outcome Measures
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Primary Outcome Measures :
  1. combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months. [ Time Frame: corrected age of 18 months ]

Secondary Outcome Measures :
  1. bronchopulmonary dysplasia [ Time Frame: discharge home ]
  2. necrotizing enterocolitis [ Time Frame: discharge home ]
  3. brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly [ Time Frame: discharge home ]
  4. retinopathy of prematurity [ Time Frame: discharge home ]
  5. growth failure [ Time Frame: corrected age of 18 months ]
  6. functional status at 5 years and at 11-12 years [ Time Frame: corrected age of 5 years and chronological age of 11-12 years ]

Eligibility Criteria
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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00182312


Locations
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Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Investigators
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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
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT00182312    
Other Study ID Numbers: CTMG-1999-CAP
ISRCTN44364365 ( Registry Identifier: Current Controlled Trials )
MCT-13288 ( Other Grant/Funding Number: CIHR )
MOP-102601 ( Other Grant/Funding Number: CIHR )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: September 2016
Keywords provided by McMaster University:
preterm infants
very low birthweight
apnea of prematurity
methylxanthines
developmental disabilities
Additional relevant MeSH terms:
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Apnea
Premature Birth
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Caffeine
Caffeine citrate
 Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents