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

Cynthia McEvoy

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Bronchopulmonary Dysplasia (BPD)

Treatments: Drug: Budesonide in Calfactant

Study type: Interventional

Funder types: Other

Identifiers

NCT02907593

SASSIE-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 3 to 14 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. > 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)
2. Day of life 3-14 from the date and time of delivery, with the date of birth being DOL 0
3. Intubated and mechanically ventilated and do not anticipate extubation in next 24 hours

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

0.025 mg/kg Budesonide

Experimental group

Description:

0.025 mg/kg Budesonide in Calfactant

Treatment:

Drug: Budesonide in Calfactant

0.050 mg/kg Budesonide

Experimental group

Description:

0.050 mg/kg Budesonide in Calfactant

Treatment:

Drug: Budesonide in Calfactant

0.10 mg/kg Budesonide

Experimental group

Description:

0.10 mg/kg Budesonide in Calfactant

Treatment:

Drug: Budesonide in Calfactant

0.15 mg/kg Budesonide

Experimental group

Description:

0.15 mg/kg Budesonide in Calfactant

Treatment:

Drug: Budesonide in Calfactant