Efficacy and safety of the intratracheal administration of budesonide with surfactant in very preterm infants to prevent bronchopulmonary dysplasia: randomized clinical trial.

Conditions

Bronchopulmonary dysplasia, Preterm newborns ≤32 weeks of gestational age.

Brief summary

Efficacy: Lung ultrasound LAS and IL-6 concentration in nasopharyngeal aspirate on day 7 of life., Safety: Nosocomial sepsis (defined as a positive blood culture in a patient >72 hours of life), gastrointestinal perforation, death (cause and age).

Detailed description

Lung ultrasound LAS on days 3, 14, 21, and 28 of life and 36 weeks PMA or prior to discharge., IL-6 concentration in nasopharyngeal aspirate on day 28 of life., Days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge., Incidence of BPD at 28 days and 36 weeks PMA or prior to discharge., Adverse effects of budesonide., Neurodevelopmental assessment at 2 years of life: using the Bayley III test, which evaluates cognitive, visual, fine and gross motor skills, memory, receptive and expressive language, and processing speed., Evaluation of respiratory outcomes at 2 years of life: Need and duration of home oxygen therapy, maintenance corticosteroid or bronchodilator treatment, diagnosis of pulmonary hypertension, number of hospital admissions due to respiratory causes, and details of the underlying cause.

Related papers

No related papers found yet.

Interventions

DRUGBudesonida Aldo-Unión 0

DRUG5 mg/ml suspensión para inhalación por nebulizador

DRUGCUROSURF® 120mg/vial + 240mg/vial Endotracheopulmonary Instillation Suspension

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Efficacy: Lung ultrasound LAS and IL-6 concentration in nasopharyngeal aspirate on day 7 of life., Safety: Nosocomial sepsis (defined as a positive blood culture in a patient >72 hours of life), gastrointestinal perforation, death (cause and age).	—

Secondary

Measure	Time frame
Lung ultrasound LAS on days 3, 14, 21, and 28 of life and 36 weeks PMA or prior to discharge., IL-6 concentration in nasopharyngeal aspirate on day 28 of life., Days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge., Incidence of BPD at 28 days and 36 weeks PMA or prior to discharge., Adverse effects of budesonide., Neurodevelopmental assessment at 2 years of life: using the Bayley III test, which evaluates cognitive, visual, fine and gross motor skills, memory, receptive and expressive language, and processing speed., Evaluation of respiratory outcomes at 2 years of life: Need and duration of home oxygen therapy, maintenance corticosteroid or bronchodilator treatment, diagnosis of pulmonary hypertension, number of hospital admissions due to respiratory causes, and details of the underlying cause.	—

Measure

Time frame

Lung ultrasound LAS on days 3, 14, 21, and 28 of life and 36 weeks PMA or prior to discharge., IL-6 concentration in nasopharyngeal aspirate on day 28 of life., Days of oxygen and respiratory support at 28 days of life and 36 weeks PMA or prior to discharge., Incidence of BPD at 28 days and 36 weeks PMA or prior to discharge., Adverse effects of budesonide., Neurodevelopmental assessment at 2 years of life: using the Bayley III test, which evaluates cognitive, visual, fine and gross motor skills, memory, receptive and expressive language, and processing speed., Evaluation of respiratory outcomes at 2 years of life: Need and duration of home oxygen therapy, maintenance corticosteroid or bronchodilator treatment, diagnosis of pulmonary hypertension, number of hospital admissions due to respiratory causes, and details of the underlying cause.

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Countries

Spain

Outcome results

None listed