Recruiting

Surfactants

Sponsor:

Endeavor Health

Code:

NCT06074380

Conditions

Respiratory Distress Syndrome

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

MIST surfactant

Study Details

Brief summary:

RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry criteria Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST.

Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.

Babies who require emergent intubation will not be enrolled in the interventions.

Parental Consent will be obtained prior to randomization.

Conditions

Respiratory Distress Syndrome

Study ID

NCT06074380

Start date

Jan 1, 2024

Status verified date

Aug, 2025

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30

Exclusion Criteria:

  • Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.
  • Infants who require emergent intubation will not be enrolled in the interventions.

Study Design

Enrollment

262 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Calfactant (Infasurf)

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP > 30% oxygen will be given 3ml/kg of Calfacant

experimental: Poractant alfa (Curosurf)

Neonate, 28-35 weeks gestation, less than 48 hours of age, with respiratory distress syndrome on CPAP > 30% oxygen will be given 2.5ml/kg of Poractant alfa.

Interventions

MIST surfactant

Surfactant will be given via MIST while neonate is on CPAP

Primary outcome measure

  • Number of infants requiring Endotracheal Intubation [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Matthew Derrick

18475702920mderrick@northshore.org

Locations

Northshore University Healthsystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Matthew Derrick, mbbs

8475702920mderrick@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • Pulmonary Surfactant
  • CPAP
  • Neonate

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2025-08-07.