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InfasurfAero™ Versus Sham Treatment in Preterm Newborns With RDS

ConditionsRespiratory Distress Syndrome (Neonatal)Intubation ComplicationDeath; Neonatal
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age29-36
SponsorONY

About this trial

The purpose of this clinical study is to determine the effectiveness and safety of Infasurf® administered through the InfasurfAero™, a novel oral airway delivery device specifically designed to give Infasurf in a less complicated way and without the need for a breathing tube or interrupting nasal respiratory support.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent obtained by parent or legal representative prior to or after birth

Gestational age at birth ≥ 29 0/7 AND ≤ 35 6/7 weeks

Birthweight ≥ 1,000 AND ≤ 3,500 grams

Age ≥ 1 hour AND ≤ 6 hours

Disqualifiers

Surfactant administration prior to randomization

Mechanical ventilation prior to randomization

Major congenital anomaly (suspected or confirmed)

Abnormality of the airway (suspected or confirmed)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Infasurf Aero™

    Combination product

    A single dose of Calfactant administered by pacifier interface by inhalation via the Infasurf Aero nebulizer at 6ml/kg.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Treatment ArmExperimental treatment 1 intervention
Group B: Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

CPAP failure and or death

CPAP failure is defined as a respiratory severity score (RSS) (MAP x FiO2) \>2.5 on two consecutive assessments at least 30 minutes apart, or an RSS \> 2.4 and one or more of the following: (i) Silverman-Andersen respiratory severity score (https://www.thecalculator.co/health/Silverman-Score-Calculator-1125.html) of ≥ 5 despite respiratory support. (ii) Severe apnea (2 or more episodes per hour, or 1 or more episodes requiring manual positive pressure ventilation). (iii) Respiratory acidosis (pCO2 \> 65 with a pH \< 7.2 on blood gas). RSS will be the primary indicator of CPAP failure. However with the addition of the Silverman-Anderson scores, severe apnea and respiratory acidosis, CPAP failure may occur earlier than solely defined by RSS score.

Time frame
Within 1st week of age

Secondary outcomes

1

Chronic lung disease and or death

Chronic lung disease is defined as altitude adjusted oxygen requirement at 36 weeks post menstrual age.

Time frame
36 weeks post menstrual age (PMA).
2

Incidence of MV

Incidence of Mechanical Ventilation

Time frame
36 weeks PMA
3

Duration of MV

length of time of Mechanical Ventilation

Time frame
36 weeks PMA
4

Incidence of intubation

Any occurrence of tracheal intubation

Time frame
36 weeks PMA

Other outcomes

1

Adverse events during surfactant administration.

Incidence of bradycardia and desaturation during surfactant administration.

Time frame
Birth to 72 hours of age.

Sponsors and contacts

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

ONY

Lead sponsor

Avania

Collaborator

Source ClinicalTrials.gov
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