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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003274-32-ES

Enrollment

Registered

2016-02-03

Start date

2016-07-13

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children under 3 years with acute RSV bronchiolitis which present breaks apnea

Interventions

Trade Name: Peyona Pharmaceutical Form: Solution for infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 - 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	—

Measure

Time frame

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 - 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

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Secondary

Measure	Time frame
Secondary end point(s): In both groups we will collect the following data: Birthdate Sex Birth weight Gestational age Age at entry Weight income Personal history (if it is basically healthy or has any underlying disease) Mother / father smoking Number of siblings and day care attendance Cohabiting with respiratory infection Type lactation: maternal, artificial or mixed If you received palivizumab prophylaxis Temperature Frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours until discharge. - In the group treated with caffeine also we collect data: If we started treatment with caffeine citrate, date and dose Days of treatment with caffeine citrate Day admission that treatment began with caffeine citrate Other concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen. Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of days Need for endotracheal intubation and mechanical ventilation and number of days. Need for nutritional support: gavage, parenteral nutrition. Stay in ICU / hospital Facts superinfection / need for antibiotics Other complications. In the untreated group caffeinated collect the same data except: If we started treatment with caffeine citrate doses Days of treatment with caffeine citrate Day admission that treatment began with caffeine citrate;Timepoint(s) of evaluation of this end point: In Both groups we will collect the following data at hospital admission: Demographic / clinic / treatment group and dose / frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours Until discharge data. During each visit: Days of caffeine citrate treatment / concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen / Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of	—

Measure

Time frame

Secondary end point(s): In both groups we will collect the following data: Birthdate Sex Birth weight Gestational age Age at entry Weight income Personal history (if it is basically healthy or has any underlying disease) Mother / father smoking Number of siblings and day care attendance Cohabiting with respiratory infection Type lactation: maternal, artificial or mixed If you received palivizumab prophylaxis Temperature Frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours until discharge. - In the group treated with caffeine also we collect data: If we started treatment with caffeine citrate, date and dose Days of treatment with caffeine citrate Day admission that treatment began with caffeine citrate Other concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen. Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of days Need for endotracheal intubation and mechanical ventilation and number of days. Need for nutritional support: gavage, parenteral nutrition. Stay in ICU / hospital Facts superinfection / need for antibiotics Other complications. In the untreated group caffeinated collect the same data except: If we started treatment with caffeine citrate doses Days of treatment with caffeine citrate Day admission that treatment began with caffeine citrate;Timepoint(s) of evaluation of this end point: In Both groups we will collect the following data at hospital admission: Demographic / clinic / treatment group and dose / frequency of apneas / previous day at baseline, heart and respiratory rate, oxygen saturation, CO2 and signs of respiratory distress on admission and every 24 hours Until discharge data. During each visit: Days of caffeine citrate treatment / concomitant therapy: nebulized epinephrine, nebulized hypertonic saline, oxygen / Need for noninvasive mechanical ventilation (CPAP / BiPAP) and number of

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Countries

Spain

Contacts

Public ContactMercedes Villa

Trialance

mvilla@trialance.com+34636262669

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026