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Bronchiolitis | Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants

Bronchiolitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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. Exclusion Criteria: - Hypersensitivity to caffeine. - Patients on caffeine treatment. - Cardiovascular congenital abnormalities. - Infants with a previous diagnosis of gastroesophageal reflux disease. - Hypoglycemia and/or electrolytes disorders. - Suspected sepsis. - Seizure disorders. - Inborn errors of metabolism. - Renal and/or hepatic impairment. - Major congenital anomalies of the upper and lower respiratory tract (severe tracheomalacia, trachea-esophageal fistula, diaphragmatic hernia, congenital lobar emphysema, congenital cystic adenomatoid malformation).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Bronchiolitis

Apnea

Caffeine

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Caffeine citrateSingle stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base).

Drug:Normal salinePlacebo with an equivalent volume of normal saline.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

caffeine Citrate

Normal saline

Study Status

Completed

Start Date: November 2011

Completed Date: November 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: The primary efficacy outcome in this double-blinded study was the time until last apnea episode in both groups.

Secondary Outcome: The proportion of patients with apnea resolution at 12 hours in both groups,

Study sponsors, principal investigator, and references

Principal Investigator: dr. Khalid Al-ansari, MD,FAAP

Lead Sponsor: Hamad Medical Corporation

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01435486

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