Little Lungs Study

Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia

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

Neonate Inclusion Criteria:

• Gestational age 22 0/7 to 28 6/7 weeks at birth
• Age 7-14 days
• Need invasive mechanical ventilatory support and a Fraction of Inspired Oxygen (FiO2) greater than or equal to 0.3

Birthing Parent Inclusion Criteria:

• Have a baby who meets neonate eligibility criteria and enrolls in the study.

Neonate Exclusion Criteria:

• Major congenital anomalies including congenital lung malformations and congenital diaphragmatic hernia and/or genetic disorders
• Alternative, acute clinical etiology of respiratory deterioration or increased ventilatory requirements (e.g., sepsis, pneumonia, etc.)
• History of pulmonary hemorrhage
• Antibiotic use within 48 hours
• Indomethacin or Ibuprofen use within 72 hours
• Prior treatment with corticosteroids for prevention of lung disease
• Not expected to survive for greater than 7 days at enrollment
• Determined to be unstable by the clinical team
• Enrolled in a conflicting clinical trial
• Have a birth parent aged less than 18 years
• Parent/guardian is unable to provide parental permission in English or Spanish