NCT02907593

Steroids and Surfactant in Extremely Low Gestation Age Infants Dose Escalation Trial

Steroids and Surfactant in Extremely Low Gestation Age Infants Pilot Dose Escalation Trial

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Cynthia McEvoy · Academic / Other
• Sex: All
• Age: 3 Days – 14 Days
• Healthy volunteers: Not accepted

Summary

This is a phase I/II open-label study to determine the lowest, safe, effective dose of budesonide given with calfactant as the vehicle.

Detailed description

This is a phase I/II open-label study to determine the lowest safe, effective dose of budesonide given with calfactant as the vehicle; the investigators will perform an unblinded dose escalation study. The investigators will administer four dosing levels of budesonide suspended in calfactant beginning with 0.025 mg/kg of budesonide administered to 8 extremely low gestational age newborns (ELGANs) who are intubated at 3-10 days of age. Daily doses (at the same dosage) will be administered to infants who remain intubated for a potential of 5 total doses in each patient. Subsequent groups of 8 infants each will receive 0.05 mg/kg, 0.10 mg/kg, and 0.15 mg/kg of budesonide in calfactant (up to 5 total doses in each patient). A total of up to 32 infants will be enrolled in the trial. The investigators will evaluate the clinical, laboratory and safety data from each group of treated infants to 28 days of age before moving to the next dosing level of budesonide.

Conditions

• Bronchopulmonary Dysplasia (BPD)

Interventions

Type	Name	Description
DRUG	Budesonide in Calfactant	Budesonide in Calfactant

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-09-20
• Last updated: 2025-04-04
• Results posted: 2025-04-04

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study