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

NCT01435486 | Completed DMC

• 1 other identifier: #11146/11
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiolitis; Apnea; Caffeine

Keywords

caffeine; apnea; bronchiolitis

Outcome Measures

Primary Outcomes (1)

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

  2 year 8 mongths

Secondary Outcomes (9)

• The proportion of patients with apnea resolution at 12 hours in both groups,

  2 year and 8 months

• The frequency of apnea in the first 24, 48 and 72 hours after medication administration for both arms

  2 year and 8 months

• The duration of apnea in the first 24, 48, and 72 hours after medication administration for both arms

  2 year and 8 months

• Invasive and non-invasive respiratory support needed in both groups.

  2 year 8 months

• The length of oxygen therapy needed in both groups.

  2 year 8 months

Study Arms (2)

caffeine Citrate

ACTIVE COMPARATOR

Drug: Caffeine citrate

Normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Caffeine citrate DRUG

Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base).

Also known as: arm 1

caffeine Citrate

Normal saline DRUG

Placebo with an equivalent volume of normal saline.

Also known as: arm2

Normal saline

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Pediatric emergency center, Hamad Medical Corporation

Doha, Baladīyat ad Dawḩah, 3050, Qatar

Location

Related Publications (1)

• Alansari K, Toaimah FH, Khalafalla H, El Tatawy LA, Davidson BL, Ahmed W. Caffeine for the Treatment of Apnea in Bronchiolitis: A Randomized Trial. J Pediatr. 2016 Oct;177:204-211.e3. doi: 10.1016/j.jpeds.2016.04.060. Epub 2016 May 14.

  PMID: 27189681 DERIVED

MeSH Terms

Conditions

Bronchiolitis; Apnea

Interventions

caffeine citrate; Saline Solution; JPT1 protein, human

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• dr. Khalid Al-ansari, MD,FAAP

  consultant pediatric emergency

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 16, 2011
• Study Start: November 1, 2011
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: April 1, 2015

Record last verified: 2014-05

Locations

QA (1)