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Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome

NCT ID: NCT06776783

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-24

Study Completion Date

2029-05-31

Brief Summary

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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 12 months corrected age.

Detailed Description

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Conditions

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Respiratory Distress Syndrome Pre-term Infants

Keywords

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respiratory distress syndrome surfactant pre-term infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Control Group

Group Type SHAM_COMPARATOR

Control

Intervention Type OTHER

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.

APC-0101 Group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type COMBINATION_PRODUCT

Control

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Inborn at the study site's hospital (i.e., not transferred from another hospital following delivery)
2. Gestational age at birth of 26 through 33 weeks PMA
3. Birth weight appropriate for gestational age (AGA, weight 3rd to 97th percentile on Fenton Growth Curve)
4. Birth weight ≤ 2000 grams
5. Post-natal age 1 to 24 hours at randomization
6. 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).
7. FiO2 ≥ 0.24 at randomization
8. nCPAP or mPaw ≥ 6 cm H2O at randomization
9. Chest radiograph (CXR) or lung ultrasound compatible with RDS prior to randomization

Exclusion Criteria

1. On SiPAP®, RAM® cannula, or high flow nasal cannula (HFNC) (\> 2 liters per minute \[LPM\]) at the time of randomization
2. Prior instillation of surfactant
3. Premature rupture of membranes (PROM) occurring \> 14 days before birth
4. Significant congenital/chromosomal anomaly (e.g., Pierre Robin syndrome, clinically significant congenital heart disease, or trisomy)
5. Pneumothorax
6. Other etiologies of respiratory distress
7. Enrollment in another interventional study with similar efficacy endpoints
8. Apgar score at 5 min of 0-3
9. Prior cardiopulmonary resuscitation (CPR) or epinephrine
10. 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.
11. 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.
12. Triplet or higher order multiple birth
Minimum Eligible Age

1 Hour

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aerogen Pharma Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status RECRUITING

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shannon Strom

Role: CONTACT

Phone: 9196026411

Email: [email protected]

Facility Contacts

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Ibadete Xama, MBA

Role: primary

Heeju Snyder, CCRP

Role: primary

Other Identifiers

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APC-AF-CLN-003

Identifier Type: -

Identifier Source: org_study_id