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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01435486
First received: September 8, 2011
Last updated: March 31, 2015
Last verified: May 2014
  Purpose

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 Intervention
Bronchiolitis
Apnea
Caffeine
Drug: Caffeine citrate
Drug: Normal saline

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Hamad Medical Corporation:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of patients with apnea resolution at 12 hours in both groups, [ Time Frame: 2 year and 8 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Invasive and non-invasive respiratory support needed in both groups. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: No ]
  • The length of oxygen therapy needed in both groups. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: No ]
  • The time until feeding was tolerated in both groups. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: No ]
  • The length of PICU/step-down unit stay in both groups. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: No ]
  • The overall length of hospital stay in both groups. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: No ]
  • Spot heart rate in both groups was compared every 4 hours from enrollment for up to three days. [ Time Frame: 2 year 8 months ] [ Designated as safety issue: Yes ]
    As a safety measure, spot heart rate was compared every 4 hours from enrollment for up to three days.


Enrollment: 90
Study Start Date: November 2011
Study Completion Date: November 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435486

Locations
Qatar
Pediatric emergency center, Hamad Medical Corporation
Doha, Qatar, 3050
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
Principal Investigator: dr. Khalid Al-ansari, MD,FAAP consultant pediatric emergency
  More Information

No publications provided

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT01435486     History of Changes
Other Study ID Numbers: #11146/11
Study First Received: September 8, 2011
Last Updated: March 31, 2015
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
caffeine
apnea
bronchiolitis

Additional relevant MeSH terms:
Apnea
Bronchiolitis
Bronchial Diseases
Bronchitis
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms
Signs and Symptoms, Respiratory
Caffeine
Caffeine citrate
Citric Acid
Anticoagulants
Central Nervous System Agents
Central Nervous System Stimulants
Chelating Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 26, 2015