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Completed

NCT Number: NCT00182312

Caffeine for Apnea of Prematurity (CAP)

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.

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Key information

Conditions

Apnea of Prematurity Apnea Developmental Disabilities Mental Disorders Neurodevelopmental Disorders Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Canberra Hospital, Canberra, Australian Capital Territory, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Caffeine citrate injection

Drug

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 names: CafCit

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • National Health and Medical Research Council, Australia

Registry information

Official study title

Efficacy and Safety of Methylxanthines in Very Low Birthweight Infants

Important dates

Study start
1999
Primary completion
2007
Study completion
2016
First posted
Sep 16, 2005
Registry last updated
Mar 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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