Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
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| ClinicalTrials.gov Identifier: NCT01435486 |
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Recruitment Status :
Completed
First Posted : September 16, 2011
Last Update Posted : April 1, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bronchiolitis Apnea Caffeine | Drug: Caffeine citrate Drug: Normal saline | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, 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) |
| Study Start Date : | November 2011 |
| Actual Primary Completion Date : | May 2014 |
| Actual Study Completion Date : | November 2014 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
- The primary efficacy outcome in this double-blinded study was the time until last apnea episode in both groups. [ Time Frame: 2 year 8 mongths ]
- The proportion of patients with apnea resolution at 12 hours in both groups, [ Time Frame: 2 year and 8 months ]
- The frequency of apnea in the first 24, 48 and 72 hours after medication administration for both arms [ Time Frame: 2 year and 8 months ]
- The duration of apnea in the first 24, 48, and 72 hours after medication administration for both arms [ Time Frame: 2 year and 8 months ]
- Invasive and non-invasive respiratory support needed in both groups. [ Time Frame: 2 year 8 months ]
- The length of oxygen therapy needed in both groups. [ Time Frame: 2 year 8 months ]
- The time until feeding was tolerated in both groups. [ Time Frame: 2 year 8 months ]
- The length of PICU/step-down unit stay in both groups. [ Time Frame: 2 year 8 months ]
- The overall length of hospital stay in both groups. [ Time Frame: 2 year 8 months ]
- Spot heart rate in both groups was compared every 4 hours from enrollment for up to three days. [ Time Frame: 2 year 8 months ]As a safety measure, spot heart rate was compared every 4 hours from enrollment for up to three days.
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| Ages Eligible for Study: | 1 Day to 4 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435486
| Qatar | |
| Pediatric emergency center, Hamad Medical Corporation | |
| Doha, Qatar, 3050 | |
| Principal Investigator: | dr. Khalid Al-ansari, MD,FAAP | consultant pediatric emergency |
| Responsible Party: | Hamad Medical Corporation |
| ClinicalTrials.gov Identifier: | NCT01435486 |
| Other Study ID Numbers: |
#11146/11 |
| First Posted: | September 16, 2011 Key Record Dates |
| Last Update Posted: | April 1, 2015 |
| Last Verified: | May 2014 |
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caffeine apnea bronchiolitis |
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Bronchiolitis Apnea Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Bronchitis Respiratory Tract Infections Infections Bronchial Diseases Lung Diseases, Obstructive Lung Diseases |
Caffeine Caffeine citrate Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Physiological Effects of Drugs Phosphodiesterase Inhibitors Enzyme Inhibitors Purinergic P1 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |