Little Lungs Study

Launched by UNIVERSITY OF WISCONSIN, MADISON · Feb 25, 2025

Keywords

ClinConnect Summary

The Little Lungs Study is a clinical trial designed to test a new treatment for extremely premature infants who are having serious breathing difficulties and need help from a machine to breathe (this is called invasive mechanical ventilation). Specifically, the study looks at whether a combination of two medications, late surfactant treatment and budesonide, can improve the babies' breathing and whether this treatment is safe. The trial will involve giving participants three doses of the study drug over time.

To be eligible for the study, infants must be between 7 to 14 days old, born very prematurely (between 22 and 28 weeks of pregnancy), and require mechanical support for their breathing. Parents or guardians must be able to give permission for their child to join the study and should speak either English or Spanish. It's important to note that some infants may not qualify if they have certain health issues or if their breathing problems are not severe enough. If your baby is eligible and joins the study, they will receive the new treatment, and the research team will closely monitor their health throughout the trial.

Gender

ALL

Eligibility criteria

• Neonate Inclusion Criteria:
• • Gestational age 22 0/7 to 28 6/7 weeks at birth
• • Age 7-14 days
• • Need invasive mechanical ventilatory support
• • Have at least one parent/guardian who is able to provide parental permission in English or Spanish
• Birthing Parent Inclusion Criteria:
• • Have a baby who meets neonate eligibility criteria and enrolls in the study.
• • Is able to provide consent in English or Spanish
• Neonate Exclusion Criteria:
• • Major congenital anomalies
• • History of pulmonary hemorrhage
• • Antibiotic use within 48 hours
• • Prior treatment with corticosteroids for prevention of lung disease
• • Indomethacin or Ibuprofen use within 72 hours
• • Have a birth parent aged less than 18 years
• • Respiratory severity score less than 2.4
• • Not expected to survive for greater than 7 days at enrollment
• Birthing Parent Exclusion Criteria:
• • Is aged less than 18 years