A Phase 3 interventional study of Caffeine citrate injection in Apnea of Prematurity, sponsored by McMaster University. Completed at 34 sites in 9 countries. Open to participants aged Up to 10 Days. Per ClinicalTrials.gov, last updated 2018-03-22.
Sponsored by McMaster University · Phase 3, Interventional, and Prevention
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: CafCit
combined rate of mortality and neurodevelopmental disability in survivors at a corrected age of 18 months.
Time frame: corrected age of 18 months
bronchopulmonary dysplasia
Time frame: discharge home
necrotizing enterocolitis
Time frame: discharge home
brain injury: intra- and periventricular hemorrhage, periventricular leucomalacia and/or ventriculomegaly
Time frame: discharge home
retinopathy of prematurity
Time frame: discharge home
growth failure
Time frame: 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
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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McMaster University