Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients

Study Description

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Brief Summary:

Study to test the hypothesis that aerosolized Infasurf can decrease the need for intubation and instillation of liquid surfactant to the airway.

Condition or disease	Intervention/treatment	Phase
Respiratory Distress Syndrome	Drug: Aerosolized Calfactant; Device: Solarys	Phase 3

Detailed Description:

Treatment will not be masked. The study objective is to document that aerosolized Infasurf is superior to "usual care" and provides for some patients effective surfactant therapy with less need for endotracheal intubation and instillation of a surfactant suspension into the airway. Two cohorts will be recruited: (a) patients who did not receive surfactant at birth who develop RDS in the first hours of life and (b) patients who received instillation of surfactant for RDS in the first hour of life, were extubated, and have continuing RDS.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	477 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
Actual Study Start Date :	March 29, 2017
Actual Primary Completion Date :	June 1, 2018
Estimated Study Completion Date :	July 31, 2018

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Aerosolized Calfactant; NICU Patients with a clinical diagnosis of RDS; Inspired oxygen ≥21% to maintain adequate oxygen saturation; Not Intubated; Requiring Nasal continuous positive airway pressure	Drug: Aerosolized Calfactant; Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.; Other Names: Infasurf; Calfactant; Device: Solarys; Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
No Intervention: Usual Care; There will be no protocol driven interventions in the usual care group.

Outcome Measures

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Primary Outcome Measures :

1. Intubation [ Time Frame: 72 hours ]
   Incidence of the requirement for endotracheal intubation and instillation of surfactant to "usual care".

Secondary Outcome Measures :

1. Death [ Time Frame: 28 days ]
   Incidence of death
2. Bronchopulmonary Dysplasia [ Time Frame: 28 days or discharge ]
   Incidence of Bronchopulmonary Dysplasia defined as oxygen requirement to maintain acceptable blood oxygenation saturations.
3. Severity of Acute RDS [ Time Frame: Randomization to 72 hours of age or to intubation ]
   Measured by oxygen requirements and respiratory support

Eligibility Criteria

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Ages Eligible for Study:	up to 24 Hours (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

RDS Patients

1. NICU patient, ≥1hour of age and <24 hours of age.
2. Clinical diagnosis of RDS, with or without chest X-ray data.
3. Inspired oxygen ≥21% to maintain adequate oxygen saturation.
4. Not intubated

5. Requiring:

   1. nasal continuous positive airway pressure (nCPAP).

Exclusion Criteria:

1. Congenital anomaly limiting care options or requiring early surgery.

2. Cardiopulmonary decompensation.

   1. hypotension with metabolic acidosis (base excess < -10 meq/l).
   2. Oxygen saturations < 88% at start of aerosolization.
   3. PaCO2 ≥ 60 mmHg at start of aerosolization.
3. Grade 3 or Grade 4 intraventricular hemorrhage by cranial ultrasound, if known.
4. Acute hypoxic encephalopathy with or without seizures.

Contacts and Locations

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  Show 22 Study Locations

Sponsors and Collaborators

ONY

AHRM

Investigators

Study Chair:	James Cummings, MD	Albany Medical College

More Information

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Responsible Party:	ONY
ClinicalTrials.gov Identifier:	NCT03058666 History of Changes
Other Study ID Numbers:	Aero-02
First Posted:	February 23, 2017
Last Update Posted:	June 28, 2018
Last Verified:	April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		Yes
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by ONY:

Aerosol; surfactant; calfactant; Infasurf	Respiratory Distress Syndrome; RDS; Premature; Neonates

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome, Adult; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders	Infant, Premature, Diseases; Infant, Newborn, Diseases; Calfactant; Pulmonary Surfactants; Respiratory System Agents