NCT06855043

Little Lungs Study

Pilot Randomized Controlled Trial of Late Surfactant Therapy With Budesonide for Prevention of Bronchopulmonary Dysplasia

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 7 Days – 14 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objective • To evaluate safety of late surfactant therapy with budesonide in extremely preterm infants. Secondary Objectives * To evaluate the oxygenation response to late surfactant therapy with budesonide in extremely preterm infants at 48 hours and 7 days after completion of the study intervention * To evaluate respiratory outcomes following administration of late surfactant therapy with budesonide

Conditions

• Invasive Mechanical Ventilation
• Severe Respiratory Distress Syndrome

Interventions

Type	Name	Description
DRUG	Calfactant	Participants will receive 2 daily doses of Calfactant (3 ml/kg) intratracheal administration
DRUG	Budesonide	Participants will receive 2 daily doses of Budesonide (0.25mg/kg) intratracheal administration.

Timeline

• Start date: 2026-09-01
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-03-03
• Last updated: 2026-01-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study