Little Lungs Study

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