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CompletedNCT03058666Updated May 29, 2024Results posted

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

A Phase 3 interventional study of Aerosolized Calfactant and Solarys in Respiratory Distress Syndrome, sponsored by ONY. Completed at 22 sites in United States. Open to participants aged 1 Hour to 24 Hours. Per ClinicalTrials.gov, last updated 2024-05-29.

Sponsored by ONY · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
477
Allocation
Randomized
Ages
1 Hour to 24 Hours
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Respiratory Distress Syndrome

Keywords

  • Aerosol
  • surfactant
  • calfactant
  • Infasurf
  • Respiratory Distress Syndrome
  • RDS
  • Premature
  • Neonates
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 477 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

ONY is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 24 Hours
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
477 participants (actual)

Study arms

  • Experimental
    Aerosolized Calfactant

    1. NICU Patients with a clinical diagnosis of RDS 2. Inspired oxygen ≥21% to maintain adequate oxygen saturation 3. Not Intubated 4. Requiring Nasal continuous positive airway pressure

    Drug: Aerosolized Calfactant · Device: Solarys

  • No intervention
    Usual Care

    There will be no protocol driven interventions in the usual care group.

Interventions

  • DrugAerosolized Calfactant

    Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

    Also known as: Infasurf, Calfactant

  • DeviceSolarys

    Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.

06

What researchers measure

Primary outcomes

  1. Intubation and Instillation of Liquid Surfactant

    Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

    Time frame: 72 hours

Secondary outcomes

  1. Respiratory Support Requirements

    Difference of Respiratory support at 28 days

    Time frame: 28 days

  2. Air Leak

    Percent of at risk subjects with air leak at any time

    Time frame: 28 days

07

Results

Posted May 29, 2024

Participant flow

Participant flow — Overall Study
MilestoneAerosolized CalfactantUsual Care
Started241236
Completed241236
Not completed00

Outcome measures

PrimaryIntubation and Instillation of Liquid Surfactant

Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.

Time frame:
72 hours
Reported as:
Count of participants · Participants
Intubation and Instillation of Liquid Surfactant
ParticipantsAerosolized CalfactantUsual Care
Intubation and Instillation of Liquid Surfactant69120
SecondaryRespiratory Support Requirements

Difference of Respiratory support at 28 days

Time frame:
28 days
Reported as:
Count of participants · Participants
Respiratory Support Requirements
ParticipantsAerosolized CalfactantUsual Care
Respiratory Support Requirements65124
SecondaryAir Leak

Percent of at risk subjects with air leak at any time

Time frame:
28 days
Reported as:
Count of participants · Participants
Air Leak
ParticipantsAerosolized CalfactantUsual Care
Air Leak1411

Adverse events

Collected over Birth to 28 days or discharge, whichever came first.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Aerosolized Calfactant0/241 (0%)13/241 (5.4%)225/241 (93.4%)
Usual Care1/236 (0.4%)14/236 (5.9%)219/236 (92.8%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventAerosolized CalfactantUsual Care
Air LeakRespiratory, thoracic and mediastinal disorders13/24114/236
Patent ductus arteriosusCardiac disorders6/2412/236
SepsisInfections and infestations1/2414/236
Necrotizing enterocolitisGastrointestinal disorders3/2412/236
Intraventricular hemorrhage, Grade IVNervous system disorders0/2412/236
Periventricular leukomalaciaNervous system disorders0/2412/236
Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders1/2412/236
Primary pulmonary hypertensionRespiratory, thoracic and mediastinal disorders1/2412/236
Pink colored oral discharge secretionInjury, poisoning and procedural complications2/2410/236
CoagulopathyBlood and lymphatic system disorders0/2411/236
Most frequent other events
Showing 10 of 43
Most frequent other events
EventAerosolized CalfactantUsual Care
HyperbilirubinemiaHepatobiliary disorders195/241191/236
ApneaNervous system disorders116/241108/236
AnemiaBlood and lymphatic system disorders53/24154/236
DysphagiaGastrointestinal disorders47/24137/236
HypoglycemiaMetabolism and nutrition disorders31/24138/236
SepsisInfections and infestations14/24133/236
Patent ductus arteriosusCardiac disorders25/24127/236
HyponatremiaMetabolism and nutrition disorders26/24124/236
Respiratory insufficiencyRespiratory, thoracic and mediastinal disorders24/24114/236
Bronchopulmonary dysplasiaRespiratory, thoracic and mediastinal disorders21/24117/236

Baseline characteristics

477 were randomized into the two cohorts between April 2017 and June 2018. Having reached our sample size target for cohort 1, further enrollment into cohort 2 was discontinued.

Age, Categorical
Age, Categorical(Participants)Aerosolized CalfactantUsual CareTotal
<=18 years241236477
Between 18 and 65 years000
>=65 years000
Age, Continuous
Age, Continuous(weeks)Aerosolized CalfactantUsual CareTotal
Mean33.2 ± 3.233.1 ± 3.133.2 ± 3.2
Sex: Female, Male
Sex: Female, Male(Participants)Aerosolized CalfactantUsual CareTotal
Female10095195
Male141141282
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Aerosolized CalfactantUsual CareTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Aerosolized CalfactantUsual CareTotal
United States241236477
08

Study locations

22 sites
  • USA Children's & Women's Hospital
    Mobile, Alabama 36604, United States
  • Banner - University Medical Center Phoenix
    Phoenix, Arizona 85006, United States
  • Sharp Mary Birch Hospital for Women & Newborns
    San Diego, California 92123, United States
  • Baptist Hospital of Miami
    Miami, Florida 33176, United States
  • Adventist Healthcare System, Florida Hospital
    Orlando, Florida 32803, United States
  • Johns Hopkins All Children's Hospital
    Saint Petersburg, Florida 33701, United States
  • University of South Florida, Tampa general
    Tampa, Florida 33606, United States
  • Columbus Regional Hospital
    Columbus, Georgia 31904, United States
  • OSF Saint Francis Medical Center
    Peoria, Illinois 61637, United States
  • Kentucky Children's Hospital, University of Kentucky Medical Center
    Lexington, Kentucky 40506, United States
  • Children's Hospital and Clinics
    Minneapolis, Minnesota 55404, United States
  • Children's Hospital Minnesota
    Saint Paul, Minnesota 55102, United States
  • University of Mississippi Medical Center
    Jackson, Mississippi 39216, United States
  • Sisters of Charity Hospital
    Buffalo, New York 14214, United States
  • Pitt County Memorial Hospital
    Greenville, North Carolina 27835, United States
  • The Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Jackson-Madison County General Hospital
    Jackson, Tennessee 38301, United States
  • Vanderbilt university Medical Center
    Nashville, Tennessee 37232, United States
  • North central Baptist Hospital
    San Antonio, Texas 78258, United States
  • Timpanogos Regional Medical Center
    Orem, Utah 84057, United States
  • Utah Valley Hospital
    Provo, Utah 84604, United States
  • University of Virgina Medical Center
    Charlottesville, Virginia 22903, United States
09

References and documents

Publications

  • Cummings JJ, Gerday E, Minton S, Katheria A, Albert G, Flores-Torres J, Famuyide M, Lampland A, Guthrie S, Kuehn D, Weitkamp JH, Fort P, Abu Jawdeh EG, Ryan RM, Martin GC, Swanson JR, Mulrooney N, Eyal F, Gerstmann D, Kumar P, Wilding GE, Egan EA; AERO-02 STUDY INVESTIGATORS. Aerosolized Calfactant for Newborns With Respiratory Distress: A Randomized Trial. Pediatrics. 2020 Nov;146(5):e20193967. doi: 10.1542/peds.2019-3967. Epub 2020 Oct 15. PubMed 33060258 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 25, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03058666
Lead sponsor
ONY
Responsible party
Sponsor
First posted
Feb 23, 2017
Start date
Mar 29, 2017
Primary completion
Jun 1, 2018
Completion
Jul 31, 2018
Results posted
May 29, 2024
Last update
May 29, 2024

Study contacts

James Cummings, MD
study chair · Albany Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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