Little Lungs Study
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age7-14
SponsorUniversity of Wisconsin, Madison
About this trial
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.
Eligibility criteria
Qualifiers
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
Have a baby who meets neonate eligibility criteria and enrolls in the study.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Calfactant
- Budesonide
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
Meriter Foundation
Collaborator
Source ClinicalTrials.gov