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Not Yet Recruiting NCT06855043

Little Lungs Study

Conditions: Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome

Sex: All
Ages: 7 Days – 14 Days
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 24
Sponsor: University of Wisconsin, Madison

Location: Meriter Hospital Madison Wisconsin

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.

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 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06855043). StuddyBuddy aggregates publicly available trial information.