Little Lungs Study (NCT06855043) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Little Lungs Study
United States24 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
7 Days – 14 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence or absence of acute clinical deterioration up to 60 minutes after study intervention
Timeframe: up to 60 minutes after study intervention (intervention received within 14 days of life (DOL))
2
Presence or absence of severe acute clinical deterioration up to 60 minutes after study intervention
Timeframe: up to 60 minutes after study intervention (intervention received within 14 DOL)
3
Occurrence of pneumothorax needing evacuation up to 48 hours after completion of study intervention
Timeframe: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)
4
Occurrence of pulmonary hemorrhages up to 48 hours after completion of study intervention
Timeframe: baseline to 48 hours after completion of study intervention (intervention received within 14 DOL)