A Dose-Ranging Study to Determine the Effectiveness, Safety and Tolerability of AeroFact


About this study

The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed)

2. 26 0/7 to 30 6/7 weeks of gestational age

3. Weight < 2000 grams

4. Weight appropriate for gestational age (AGA)

5. twenty-four hours at the initiation of study treatment

6. RSS (MAP x FiO2) 1.4 – 2.0 on nCPAP or nIMV

Exclusion Criteria:

1. Apgar score <=5 at five minutes after birth

2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room

3. Premature rupture of membranes (PROM) > 7 days, or known maternal sepsis with PROM prior to 7 days

4. Evidence of chorioamnionitis (maternal temperature >38.9ºC or between 38.0ºC and 38.9ºC with foul-smelling amniotic fluid)

5. Base deficit > -10 mEq/L on clinically indicated blood gas at time of randomization

6. Need for intubation and/or mechanical ventilation prior to enrollment

7. HFNC and RAM Cannula or are not allowed to determine eligibility

8. Prior instillation of surfactant

9. Enrollment in another treatment study with competing outcomes

10. Active pneumothorax requiring chest tube

11. Significant congenital anomaly

12. Known or suspected chromosomal abnormality

13. Other diseases interfering with cardiopulmonary functions (hydrops fetalis, toxoplasmosis, rubella, cytomegalovirus, herpes simplex)

14. Concomitant treatment with inhaled nitric oxide

15. Suspected PPHN with sustained pre/post SpO2 ductal differences > 10%

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Ellen Bendel-Stenzel, M.D.

Open for enrollment

Contact information:

Kelly Haines R.R.T., L.R.T.

(507) 255-6804


More information


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