Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
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:
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.
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 D5W 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-pharmacologic 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 PICU for further monitoring monitoring when indicated.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants: A Randomized, Double Blind, Controlled Trial (RCT)|
- The length of pediatric intensive care unit stays (days). [ Time Frame: 1 year 8 mongths ] [ Designated as safety issue: No ]
- The duration of non-invasive respiratory support (days). [ Time Frame: 1 year and 8 months ] [ Designated as safety issue: No ]
- The rate of endotracheal intubation [ Time Frame: 1 year and 8 months ] [ Designated as safety issue: No ]
- The duration of total respiratory support (days) [ Time Frame: 1 year 8 months ] [ Designated as safety issue: No ]
- The overall length of hospital stays (days) [ Time Frame: 1 year 8 months ] [ Designated as safety issue: No ]
- The frequency of apneic episodes [ Time Frame: 1 year 8 months ] [ Designated as safety issue: No ]
- Duration of mechanical ventilation (days) [ Time Frame: 1 year 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: caffeine Citrate||
Drug: Caffeine citrate
Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base).
Other Name: arm 1
|Placebo Comparator: Normal saline||
Drug: Normal saline
Placebo with an equivalent volume of normal saline.
Other Name: arm2
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435486
|Contact: Dr.Khalid Al-ansari, MD||+974 44396022 ext email@example.com|
|Contact: Dr.Fatihi Toaimah, MDfirstname.lastname@example.org|
|Pediatric emergency center, Hamad Medical Corporation||Recruiting|
|Doha, Qatar, 3050|
|Contact: dr. khalied al ansari +974 44396022 ext 6006 email@example.com|
|Principal Investigator: dr.khalid Al-ansari, consutlant|
|Principal Investigator:||dr. Khalid Al-ansari, MD,FAAP||consultant pediatric emergency|