This clinical trial is being done to evaluate the safety and clinical response of late surfactant treatment with budesonide in extremely preterm infants requiring mechanical ventilation at 7-14 days of age.
Primary Objective • To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants. Secondary Objectives * To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention * To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.
Meriter Hospital
Madison, Wisconsin, United States
American Family Children's Hospital
Madison, Wisconsin, United States
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention
Presence or absence of acute clinical deterioration - defined as desaturation less than 80 percent and/or bradycardia less than 100 beats per minute (bpm) - during the study intervention and up to 60 minutes after study intervention.
Time frame: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention
Presence or absence of severe acute clinical deterioration - defined as desaturation less than 60 percent and/or bradycardia less than 80 bpm - during the study intervention and up to 60 minutes after study intervention.
Time frame: up to 60 minutes after study intervention (intervention received within 14 DOL)
Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention
A yes or no question of whether there was pneumothorax (air in the pleural cavity) detected via chest x-ray, needing evacuation from baseline to 48 hours after completion of study intervention
Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention
A yes or no question of whether pulmonary hemorrhage (bleeding in lungs) was observed in the endotracheal tube from baseline to 48 hours after completion of study intervention.
Time frame: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
Change in Respiratory Severity Score (RSS)
RSS is the mean airway pressure multiplied by the fraction of inspired oxygen, a change toward higher scores indicates more severe respiratory symptoms.
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Time frame: Baseline to 7 days post-intervention (intervention received within 14 DOL)
Death or Grade 3 Bronchopulmonary Dysplasia (BPD) by 36 0/7 weeks Post-Menstrual Age (PMA)
Time frame: up to 36 0/7 weeks PMA
Days of mechanical ventilation by 36 0/7 weeks PMA
Days of mechanical ventilation by 36 0/7 weeks PMA (If an infant died before 36 0/7 weeks, time from death to 36 0/7 weeks PMA will be considered as mechanical ventilation days)
Time frame: up to 36 0/7 weeks PMA