Effect of caffeine citrate in acute bronchiolitis symptoms of apnea in neonates and infants during the first three months of life

Phase 1

• Conditions: Children under 3 years with acute RSV bronchiolitis which present breaks apnea; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-003274-32-ES
• Lead Sponsor: Dra Maria Luz Couce

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-03
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

-Neonatos Aged between 0 and 90 days days diagnosed with acute respiratory syncytial virus bronchiolitis who present clinical symptoms of apnea
-Informed Consent participation in the study, signed by parents or legal guardians of the newborn
Are the trial subjects under 18? yes
Number of subjects for this age range: 105
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Which the family does not accept the informed consent
- Patients who are being treated with caffeine
- Patients with severe kidney or liver failure.
- Caffeine increases heart rate, left ventricular volume and stroke volume output. Consequently newborns with known cardiovascular disease are excluded from this study.
-Patients with hypoglycemia and / or electrolyte imbalance
-Patients treated for gastroesophageal reflux
- History of seizures
-Patients with severe birth defects of the respiratory tract (severe tracheomalacia, tracheoesophageal fistula, diaphragmatic hernia, congenital lobar emphysema, cystic adenomatoid malformation)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether treatment with caffeine improves clinically children under 3 months with acute bronchiolitis RSV having apnea pauses, decreasing the frequency and intensity of these;Secondary Objective: Assess whether the number of days of hospitalization is reduced<br>- Study of various clinical variables such as prematurity, birth weight, presence of comorbid conditions (heart disease, bronchopulmonary dysplasia ...);Primary end point(s): Reduction of at least 50% of apneas;Timepoint(s) of evaluation of this end point: At 5 days of treatment