Caffeine for Apnea of Prematurity (CAP)

March 20, 2018 updated by: McMaster University

Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5006
        • Women's & Children's Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Mercy Hospital for Women
      • Melbourne, Victoria, Australia, 3053
        • Royal Women's Hospital
      • Quebec, Canada, G1L 3L5
        • Centre Hospitalier Universitaire de Quebec
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Foothills Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Children's & Women's Health Centre of BC
      • Victoria, British Columbia, Canada, V8Z 6R5
        • Victoria General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Moncton Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
        • McMaster University
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5S 1B2
        • Sunnybrook & Women's College Health Science Centre
      • Windsor, Ontario, Canada, N8W 1L9
        • Windsor Regional Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • University of Sherbrooke
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
      • Munich, Germany, 81377
        • Ludwig Maximilian University
      • Tuebingen, Germany, D-72076
        • University of Tuebingen
      • Beer Sheva, Israel, 84101
        • Soroka University Medical Center
      • Kfar-Saba, Israel, 44281
        • Meir General Hospital
      • Rehovot, Israel
        • Kaplan Medical Center
      • Amsterdam, Netherlands, 1100 DD
        • Academisch Medisch Centrum
      • Maastricht, Netherlands
        • University Hospital Maastricht
      • Stockholm, Sweden, SE-17176
        • Astrid Lindgren's Children's Hospital
      • Basel, Switzerland, CH-4005
        • University Children's Hospital Basel
      • Geneva, Switzerland, 1211
        • University Hospitals of Geneve
      • Zurich, Switzerland, CH-8091
        • University of Zurich
      • Middlesbrough, United Kingdom, TS4 3BW
        • South Cleveland Hospital
      • Newcastle-upon-Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary
    • Northern Ireland
      • Belfast, Northern Ireland, United Kingdom, BT12 6BB
        • Royal Maternity Hospital
    • New York
      • Brooklyn, New York, United States, 11201
        • Brooklyn Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.
Time Frame: corrected age of 18 months
corrected age of 18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
bronchopulmonary dysplasia
Time Frame: discharge home
discharge home
necrotizing enterocolitis
Time Frame: discharge home
discharge home
brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly
Time Frame: discharge home
discharge home
retinopathy of prematurity
Time Frame: discharge home
discharge home
growth failure
Time Frame: corrected age of 18 months
corrected age of 18 months
functional status at 5 years and at 11-12 years
Time Frame: corrected age of 5 years and chronological age of 11-12 years
corrected age of 5 years and chronological age of 11-12 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Barbara K Schmidt, MD, 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1999

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 16, 2005

Study Record Updates

Last Update Posted (ACTUAL)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

September 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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