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

Overview

Información sobre este estudio

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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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%

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Ellen Bendel-Stenzel, M.D.

Abierto para la inscripción

Contact information:

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

(507) 255-6804

Haines.Kelly@mayo.edu

More information

Publicaciones

Publications are currently not available