Caffeine for Apnea of Prematurity (CAP)
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | October 1999 |
| End Date: | July 2016 |
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.
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.
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
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