Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
Viral bronchiolitis is the most common lower respiratory tract infection of infancy. Apnea is
a complication of bronchiolitis, reported in 16 - 21% of cases. Caffeine, a
trimethylxanthine, acts as an antagonist to endogenous adenosine and a potent central nervous
system stimulant. In apnea of prematurity, caffeine is believed to work by increasing central
respiratory drive.
Infants ≤4 months of age, presenting to pediatric emergency center Al-Sadd, from September
2011 to May 2014, with a diagnosis of viral bronchiolitis associated with apnea.
A randomized, double-blind, controlled trial with a sample size of 45 patients per group
Data Collection methods, instruments used measurements:
Randomization:
In the emergency department, the patients will be assigned to either one of the two
treatments using a computer-generated randomized numbers in a 1:1 ratio. Pharmacy will
prepare sequential sealed vials containing the experimental drugs. Randomization code will be
revealed only after all patients completed the study. The medical team in addition to the
patients will be blinded to the medication delivered. There will be no detectable difference
in the color, smell of the two study treatments.
Guardians or parents of eligible infants will be approached regarding the study, explaining
the purpose and the treatment modalities. Patients will be included after obtaining a verbal
and written consent.
Study Intervention:
Treatment 1: Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine
citrate (25mg caffeine citrate equal to 12.5mg caffeine base).
Treatment 2: Placebo with an equivalent volume of normal saline. Calculated study medications
will be diluted with Dextrose 5% in Water to 20 ml and will be given intravenous over 30
minutes using syringe infusion pump.
After random assignment, eligible infants will receive one of the study treatments.
Non-pharmacological therapies may be used as necessary to control apnea. Antibiotics and
antipyretics may be used as per the discretion of the treating physician.
After stabilization of patients as usually done in Pediatric Emergency Center , patients will
be admitted to pediatric intensive care unit (PICU) for further monitoring monitoring when
indicated.