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Non Inferiority Trial Investigating Surfactants Administered Via MIST

ConditionRespiratory Distress Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeUp to 48
SponsorEndeavor Health

About this trial

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.

Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.

Babies who require emergent intubation will not be enrolled in the interventions.

Parental Consent will be obtained prior to randomization.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30

Disqualifiers

Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.

Infants who require emergent intubation will not be enrolled in the interventions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MIST surfactant

    Drug

    Surfactant will be given via MIST while neonate is on CPAP

Treatment groups

262 Participants
are divided into 2 treatment groups
Group A: Calfactant (Infasurf)Experimental treatment 1 intervention
Group B: Poractant alfa (Curosurf)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of infants requiring Endotracheal Intubation

Infants will have an endotracheal placed if their inspired oxygen is \>45% for more than 15 minutes

Time frame
7 days

Secondary outcomes

1

Duration of positive pressure support

Endotracheal ventilation or Non-invasive Ventilation or CPAP or NC flow\>2 L

Time frame
36 weeks corrected gestational age
2

Duration of Supplemental oxygen

Oxygen requirement to keep saturations \>95%

Time frame
36 weeks corrected gestational age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Endeavor Health

Lead sponsor

Source ClinicalTrials.gov
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