TerminatedPhase 1/2

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

United States25 participantsStarted 2016-09

Plain-language 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.

Who can participate

Age range3 Days – 14 Days

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \> 23 0/7 and \< 27 6/7 weeks of gestational age based on center's best estimate of due date (using earliest obstetrical ultrasound, last menstrual period, examination, and other pertinent available information)
✓. Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0
✓. Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours

Exclusion criteria

✕. Serious congenital malformations or chromosomal abnormality
✕. Likely to be extubated in next 24 hours
✕. Clinically unstable
✕. Infants who have received systemic steroids prior to dosing with study medication.
✕. Infants who have received Indocin, Ibuprofen, or acetaminophen ≤ 96 hours prior to enrollment window ending

What they're measuring

Number of ELGANs With Clinical and Anti-inflammatory Efficacy of Escalating Doses of Budesonide Determined by Monitoring Respiratory Severity Score (RSS)

Timeframe: 28 days of life for each dosing group

The Clinical and Anti-inflammatory Efficacy of Escalating Doses of Budesonide Suspended in Calfactant and Given Into the Lungs of ELGANs by Monitoring Tracheal Aspirate Cytokine Levels.

Timeframe: 28 days of life for each dosing group

Trial details

NCT IDNCT02907593

SponsorCynthia McEvoy

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-04

Results submitted2019-03-20

View on ClinicalTrials.gov More Bronchopulmonary Dysplasia (BPD) trials