Trial record 4 of 15 for:    "Infantile apnea"

Caffeine for Apnea of Prematurity (CAP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Barbara Schmidt, McMaster University
ClinicalTrials.gov Identifier:
NCT00182312
First received: September 13, 2005
Last updated: June 23, 2014
Last verified: June 2014
  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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
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
  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182312

  Show 34 Study Locations
Sponsors and Collaborators
McMaster University
Canadian Institutes of Health Research (CIHR)
National Health and Medical Research Council, Australia
Investigators
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:
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: June 23, 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
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Caffeine
Caffeine citrate
Central Nervous System Agents
Central Nervous System Stimulants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014