NCT06776783

Brief Summary

This is a 2-part, prospective, randomized, blinded, sham-controlled, multi-center study comparing preterm subjects with RDS who are treated with APC-0101 and nCPAP/NIV to subjects treated with nCPAP/NIV alone (Sham). In Part 1, subjects will be followed until they reach 40 weeks post-menstrual age (PMA) or are discharged from the NICU, whichever comes first. In Part 2, subjects will undergo post-term follow-up through 24 months corrected age.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
36mo left

Started Sep 2025

Typical duration for phase_3

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Sep 2025May 2029

First Submitted

Initial submission to the registry

January 10, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 15, 2025

Completed
8 months until next milestone

Study Start

First participant enrolled

September 24, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.6 years

First QC Date

January 10, 2025

Last Update Submit

April 13, 2026

Conditions

Respiratory Distress SyndromePre-term Infants

Keywords

respiratory distress syndromesurfactantpre-term infant

Outcome Measures

Primary Outcomes (1)

  • Failure Criteria

    Number (%) of subjects who meet the predetermined criteria for failure of nCPAP/NIV

    First 7 days of life

Secondary Outcomes (3)

  • Instilled Bolus Surfactant

    First 72 hours of life

  • Multiple Bolus Surfactant Doses

    First 72 hours of life

  • Total Number of Bolus Surfactant Doses

    First 72 hours of life

Study Arms (2)

Control Group

SHAM COMPARATOR
Other: Control

APC-0101 Group

EXPERIMENTAL
Combination Product: APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)

Interventions

APC-0101 (SF-RI 1 surfactant for inhalation combined with a dedicated delivery system)COMBINATION_PRODUCT

Subjects in the APC-0101 group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface and APC-0101 treatment will be started.

APC-0101 Group
ControlOTHER

Subjects in the Control group will be changed from their current nCPAP/NIV interface to the APC-0101 nCPAP/NIV interface but an empty vial will be used instead of APC-0101.

Control Group

Eligibility Criteria

Age1 Hour - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
  • Gestational age at birth of 26 through 33 weeks PMA
  • Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
  • Birth weight ≤ 2000 grams
  • Post-natal age 1 to 24 hours at randomization
  • On nCPAP or NIV for at least 30 minutes with RSS = 1.4 - 2.0 to maintain SpO2 90-95% at randomization. RSS is calculated as (nCPAP cm H2O) × (FiO2) or as (NIV mean airway pressure cm H2O) × (FiO2).
  • FiO2 ≥ 0.24 at randomization
  • nCPAP or mPaw ≥ 6 cm H2O at randomization
  • Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

You may not qualify if:

  • On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
  • Prior instillation of surfactant
  • Premature rupture of membranes (PROM) occurring \> 14 days before birth
  • Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
  • Pneumothorax
  • Other etiologies of respiratory distress
  • Enrollment in another interventional study with similar efficacy endpoints
  • Apgar score at 5 min of 0-3
  • Prior cardiopulmonary resuscitation (CPR) or epinephrine
  • Base Deficit \> 15 mEq/L on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization. Note that arterial blood gas is not required prior to randomization.
  • Partial pressure of carbon dioxide (PaCO2) \> 65 mmHg on most recent arterial blood gas (not capillary blood gas, venous blood gas, or cord gas) prior to randomization.
  • Triplet or higher order multiple birth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

RECRUITING

Jacobs Medical Center

La Jolla, California, 92037, United States

RECRUITING

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

Advent Health

Orlando, Florida, 32803, United States

RECRUITING

Memorial Hospital of South Bend

South Bend, Indiana, 46601, United States

RECRUITING

Goryeb Children's Hospital

Morristown, New Jersey, 07960, United States

RECRUITING

The Trustees of Columbia University in the City of New York

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center

The Bronx, New York, 10461, United States

RECRUITING

Maria Farreri Children's Hospital

Valhalla, New York, 10595, United States

RECRUITING

Christus Children's Hospital

San Antonio, Texas, 78207, United States

RECRUITING

University of Virginia School of Medicine

Charlottesville, Virginia, 22903, United States

RECRUITING

WVU Medicine Children's Hospital

Morgantown, West Virginia, 26506, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Shannon Strom

CONTACT

9196026411sstrom@aerogenpharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinding/masking will be accomplished by a two-level redundant process. First, a screen (or private room) will be placed around the subject's bedside area and the APC-0101 Controller during APC-0101 or Sham treatment. This will ensure that no members of the clinical team, other than the blinded bedside nurse, will see the subject or the Controller throughout treatment. Second, the Controller and subject's face will be shielded so the blinded bedside nurse cannot determine whether the subject is receiving APC-0101 or Sham treatment. A trained, unblinded, staff member (e.g., a respiratory therapist) will set up the Controller, but will not be involved with making decisions about the respiratory support of the subject. Parents and all members of the clinical team who will make decisions about respiratory support, including FiO2, assessment of Failure Criteria, or assessment of AEs, will remain blinded throughout the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2025

First Posted

January 15, 2025

Study Start

September 24, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2029

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(12)