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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01435486
First received: September 8, 2011
Last updated: May 20, 2014
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 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.


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 length of pediatric intensive care unit stays (days). [ Time Frame: 1 year 8 mongths ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
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)
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 April 2013, 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

Contacts
Contact: Dr.Khalid Al-ansari, MD +974 44396022 ext 6006 dkmaa@hotmail.com
Contact: Dr.Fatihi Toaimah, MD +97455628632 fsoliman2@yahoo.com

Locations
Qatar
Pediatric emergency center, Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: dr. khalied al ansari    +974 44396022 ext 6006    dkmaa@hotmail.com   
Principal Investigator: dr.khalid Al-ansari, consutlant         
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: May 20, 2014
Health Authority: Qatar: Hamad Medical Corporation

Keywords provided by Hamad Medical Corporation:
caffeine
apnea
bronchiolitis

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

ClinicalTrials.gov processed this record on July 31, 2014