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

This study is currently recruiting participants.
Verified November 2012 by Hamad Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Hamad Medical Corporation
ClinicalTrials.gov Identifier:
NCT01435486
First received: September 8, 2011
Last updated: November 7, 2012
Last verified: November 2012

September 8, 2011
November 7, 2012
November 2011
April 2013   (final data collection date for primary outcome measure)
The length of pediatric intensive care unit stays (days). [ Time Frame: 1 year 8 mongths ] [ Designated as safety issue: No ]
The length of pediatric intensive care unit stays (days). [ Time Frame: 1 year 8 months ] [ Designated as safety issue: Yes ]
The number of days a neonate stays in the pediatric intensive care unit
Complete list of historical versions of study NCT01435486 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants
Caffeine Citrate for the Treatment of Apnea Associated With Bronchiolitis in Young Infants: A Randomized, Double Blind, Controlled Trial (RCT)

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 April 2013, with a diagnosis of viral bronchiolitis associated with apnea.

A randomized, double-blind, controlled trial with a sample size of 25 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.

Study area/setting:

Pediatric emergency center Al-Sadd, (P.E.C.) is the main pediatric emergency centre in the state of Qatar with approximately 200,000 visits annually. It has a capacity of 42 observation beds providing most of the inpatient facilities except for intensive care monitoring. Patients admitted to the Pediatric Emergency Center are managed there until discharged home unless an Intensive Care Unit admission is required.

Study Subjects:

  • 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).

Study Design: A randomized, double-blind, controlled trial.

Sample Size:

The mean length of Pediatric Intensive Care Unit stay (in days) was found to be 5±3.9, derived from retrospective analysis of the previous available data from January 1, 2010 to December 31, 2010. A difference of 50% between treatments groups for mean length of intensive care stay (in days) would be clinically significant. With a sample size of 25 patients per group, there would be 80% power to find a significant difference (two-sided) such as 5±3.9 in one group and 2.5±2.0 in the other group. To compensate for dropouts, it was planned to recruit 55 patients altogether. The formula used for sample size calculation (comparing two means):

n = [2 (Zα/2 + Zβ) 2 * s2] / (x1-x2)2 Where, Zα and Zβ are the values standard normal variate, s is the polled variation, x1and x2 are the means in group 1 and group 2 respectively.

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 such as supplemental oxygen, non invasive respiratory support, endotracheal intubation and mechanical ventilation 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 for further monitoring when indicated.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Bronchiolitis
  • Apnea
  • Caffeine
  • 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
  • Drug: Normal saline
    Placebo with an equivalent volume of normal saline.
    Other Name: arm2
  • Active Comparator: caffeine arm
    Intervention: Drug: Caffeine citrate
  • Placebo Comparator: placebo arm
    Intervention: Drug: Normal saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2013
April 2013   (final data collection date for primary outcome measure)

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).
Both
up to 4 Months
No
Contact: Dr.Khalid Al-ansari, MD +974 44396022 ext 6006 dkmaa@hotmail.com
Contact: Dr.Fatihi Toaimah, MD +97455628632 fsoliman2@yahoo.com
Qatar
 
NCT01435486
#11146/11
Yes
Hamad Medical Corporation
Hamad Medical Corporation
Not Provided
Principal Investigator: dr. Khalid Al-ansari, MD,FAAP consultant pediatric emergency
Hamad Medical Corporation
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP