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Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

NCT07350018 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2026-04-28

No results posted yet for this study

Summary

Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin catheter, without the need for endotracheal intubation. This approach may reduce lung injury and improve respiratory outcomes in spontaneously breathing preterm infants. This multicenter, prospective, randomized study aims to compare the clinical effectiveness of poractant alfa and calfactant when administered using the LISA technique in preterm infants born at less than 30 weeks' gestation with RDS who are not intubated. The study will evaluate short-term outcomes, including the need for intubation, repeat surfactant administration, and respiratory support during the first 72 hours of life, as well as longer-term outcomes such as bronchopulmonary dysplasia and other neonatal morbidities.

Conditions

  • Respiratory Distress Syndrome in Premature Infants
  • Respiratory Distress Syndrome (RDS)
  • Surfactant

Interventions

DRUG

Poractant alfa

Poractant alfa will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (200 mg/kg initial dose, 100 mg/kg repeat dose)

DRUG

Calfactant

Calfactant will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (100 mg/kg initial and repeat dose)

Sponsors & Collaborators

  • Uludag University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
0 Hours
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-02-20
Completion
2027-02-20
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350018 on ClinicalTrials.gov