Recruiting

Surfactant

Sponsor:

Endeavor Health

Code:

NCT06007547

Conditions

Respiratory Distress Syndrome, Newborn

Premature Birth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Poractant Alfa

Study Details

Brief summary:

The purpose of this study is to explore the question: Does prophylactic administration of exogenous surfactant in the delivery room, using a minimally-invasive technique, improve outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same technique?

Conditions

Respiratory Distress Syndrome, Newborn

Premature Birth

Study ID

NCT06007547

Start date

Jan 1, 2024

Status verified date

Aug, 2025

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Gestational age <30 weeks
  • Antenatal consent from Parent

Exclusion Criteria:

  • Congenital anomalies
  • Alternate cause of respiratory distress

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prophylactic Surfactant via Minimally Invasive Technique

Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).

active comparator: Rescue Surfactant via Minimally Invasive Technique

The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.

Interventions

Poractant Alfa

Poractant alfa (Curosurf) 200mg/kg administered under direct laryngoscopy using a surfactant instillation catheter

Primary outcome measure

  • Endotracheal Intubation [ Time Frame: 7 days ]

Central Contacts and Locations

Central contacts

Matthew Derrick, MBBS

8475702920mderrick@northshore.org

Locations

Northshore University Healthsystem

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Matthew Derrick, mbbs

847-570-2920mderrick@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Aug 7, 2025

Last verified

Aug, 2025

Keywords

  • Respiratory Distress Syndrome
  • surfactant
  • Minimally invasive Surfactant Therapy

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.