Little Lungs Study: Calfactant and Budesonide for Preterm Infants
This study, called the "Little Lungs Study," is looking at the safety and effectiveness of giving two medications, Calfactant and Budesonide, to extremely premature infants who are 7 to 14 days old. These infants need help breathing with a machine (invasive mechanical ventilation) and have severe breathing problems (respiratory distress syndrome). The study will give these medications directly into the windpipe. Researchers will watch closely for any immediate problems within 60 minutes after treatment, and for a collapsed lung (pneumothorax) up to 48 hours later. The study aims to enroll 24 infants. The current status of the study is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 48 hours after the study intervention is completed to check for certain outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Little Lungs Study
At a glance
Conditions
NCT06855043
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
American Family Children's Hospital
Madison, Wisconsinstudy coordinator listed
Meriter Hospital
Madison, Wisconsinstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Dinushan Kaluarachchi, MBBS · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Presence or absence of acute clinical deterioration up to 60 minutes after study interventionup to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
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.
- Presence or absence of severe acute clinical deterioration up to 60 minutes after study interventionup to 60 minutes after study intervention (intervention received within 14 DOL)
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.
- Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study interventionbaseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
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
- Occurrence of pulmonary hemorrhages up to 48 hours after completion of study interventionbaseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
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.