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

Brief Title

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

Official Title

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

Brief 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.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

The clinical and anti-inflammatory efficacy of escalating doses of budesonide suspended in calfactant and given into the lungs of ELGANs by monitoring respiratory severity score (RSS).

Secondary Outcome

 Adverse Events/Subject Safety

Condition

Bronchopulmonary Dysplasia (BPD)

Intervention

Budesonide in Calfactant

Study Arms / Comparison Groups

 0.025 mg/kg Budesonide

Description:  0.025 mg/kg Budesonide in Calfactant

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

25

Start Date

September 2016

Completion Date

April 2018

Primary Completion Date

April 2018

Eligibility Criteria

        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
      

Gender

All

Ages

3 Days - 14 Days

Accepts Healthy Volunteers

No

Contacts

Cynthia McEvoy, MD, MCR, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02907593

Organization ID

SASSIE-001

Responsible Party

Sponsor-Investigator

Study Sponsor

Cynthia McEvoy

Collaborators

 Thrasher Research Fund

Study Sponsor

Cynthia McEvoy, MD, MCR, Principal Investigator, Oregon Health and Science University

Verification Date

October 2018