Trial · NCT03058666

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

NCT03058666, Phase 3, Completed, ONY; results first posted 2024-05-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients. Trials, record NCT03058666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03058666

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Comparison of Aerosol Delivery of Infasurf to Usual Care in Spontaneously Breathing RDS Patients
NCT number: NCT03058666
Status: Completed
Phases: Phase 3
Enrollment: 477 participants, actual
Lead sponsor: ONY
Conditions: Respiratory Distress Syndrome
Interventions: Aerosolized Calfactant, Solarys
First posted: 2017-02-23
Last updated: 2024-05-29
Results first posted: 2024-05-29

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Intubation and Instillation of Liquid Surfactant	72 hours	Percent of at risk subjects receiving endotracheal intubation and instillation of surfactant within the first 72 hours.
Secondary	Respiratory Support Requirements	28 days	Difference of Respiratory support at 28 days
Secondary	Air Leak	28 days	Percent of at risk subjects with air leak at any time

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Intubation and Instillation of Liquid Surfactant	72 hours	All enrolled patients.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Respiratory Support Requirements	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Air Leak	28 days	All Enrolled	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Intubation and Instillation of Liquid Surfactant	Aerosolized Calfactant	69	Participants
Intubation and Instillation of Liquid Surfactant	Usual Care	120	Participants
Respiratory Support Requirements	Aerosolized Calfactant	65	Participants
Respiratory Support Requirements	Usual Care	124	Participants
Air Leak	Aerosolized Calfactant	14	Participants
Air Leak	Usual Care	11	Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Aerosolized Calfactant	241
Overall Study	STARTED	Usual Care	236
Overall Study	COMPLETED	Aerosolized Calfactant	241
Overall Study	COMPLETED	Usual Care	236
Overall Study	NOT COMPLETED	Aerosolized Calfactant	0
Overall Study	NOT COMPLETED	Usual Care	0

Source ClinicalTrials.gov

Adverse events122

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anemia	Blood and lymphatic system disorders	Aerosolized Calfactant	53	241	53
other	Anemia	Blood and lymphatic system disorders	Usual Care	54	236	54
other	Neutropenia	Blood and lymphatic system disorders	Aerosolized Calfactant	8	241	8
other	Neutropenia	Blood and lymphatic system disorders	Usual Care	4	236	4
other	Polycythemia	Blood and lymphatic system disorders	Aerosolized Calfactant	4	241	4
other	Polycythemia	Blood and lymphatic system disorders	Usual Care	1	236	1
other	Thrombocytopenia	Blood and lymphatic system disorders	Aerosolized Calfactant	16	241	16
other	Thrombocytopenia	Blood and lymphatic system disorders	Usual Care	12	236	12
other	Bradycardia	Cardiac disorders	Aerosolized Calfactant	7	241	7
other	Bradycardia	Cardiac disorders	Usual Care	6	236	6

1 to 10 of 122Source ClinicalTrials.gov

See all 122 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aerosolized Calfactant	0	241
Total, all-cause mortality	Usual Care	1	236
Total, other adverse events	Aerosolized Calfactant	225	241
Total, other adverse events	Usual Care	219	236
Total, serious adverse events	Aerosolized Calfactant	13	241
Total, serious adverse events	Usual Care	14	236

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33060258	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Aerosolized Calfactant vs Usual Care: Air Leak	Trial comparisons
Aerosolized Calfactant vs Usual Care: deaths from any cause	Trial comparisons
Aerosolized Calfactant vs Usual Care: Intubation and Instillation of Liquid Surfactant	Trial comparisons
Aerosolized Calfactant vs Usual Care: Respiratory Support Requirements	Trial comparisons
Aerosolized Calfactant vs Usual Care: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03058666

GET https://conductscience.org/api/trials/v1/NCT03058666/events?page=2

API reference For AI assistants