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

NCT07350018 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 2025-20/9
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Respiratory Distress Syndrome; Premature infant; Poractant alfa; Calfactant; surfactant treatment; Less Invasive Surfactant Administration; LISA

Outcome Measures

Primary Outcomes (1)

• Need for endotracheal intubation within the first 72 hours of life

  The need for endotracheal intubation within the first 72 hours of life in preterm infants born at 24 1/7-29 6/7 weeks' gestation receiving calfactant or poractant alfa via LISA.

  Up to 72 hours after birth.

Secondary Outcomes (11)

• Need for Repeat Surfactant Administration

  Up to 72 hours after birth.

• Adverse Events During Surfactant Administration

  During the surfactant administration and up to 72 hours after birth.

• Bronchopulmonary dysplasia

  At 36 weeks' postmenstrual age or discharge, whichever occurred first.

• Retinopathy of Prematurity

  From birth until discharge, assessed up to 44 weeks' postmenstrual age.

• Patent Ductus Arteriosus

  From birth until the date of the first documented patent ductus arteriosus requiring medical or surgical treatment or the date of hospital discharge, whichever came first, assessed up to 36 weeks' postmenstrual age.

Study Arms (2)

Poractant alfa (LISA)

ACTIVE COMPARATOR

Preterm infants with respiratory distress syndrome (RDS) will receive poractant alfa via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support.

Drug: Poractant alfa

Calfactant (LISA)

ACTIVE COMPARATOR

Preterm infants with respiratory distress syndrome (RDS) will receive calfactant via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support.

Drug: Calfactant

Interventions

Poractant alfa DRUG

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)

Poractant alfa (LISA)

Calfactant DRUG

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)

Calfactant (LISA)

Eligibility Criteria

• Age: 0 Hours - 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Born at a participating study center hospital.
• Gestational age between 24 1/7 and 29 6/7 weeks (\<30 0/7 weeks).
• Postnatal age within the first 6 hours of life.
• Being on non-invasive respiratory support.
• Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS).
• Indication for surfactant therapy defined as a requirement for FiO₂ \>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O.
• Written informed consent obtained from a parent or legal guardian.

You may not qualify if:

• Infants who were intubated for any reason before the decision to administer surfactant.
• Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \<7.0 and base excess (BE) ≤-12.
• Presence of major congenital anomalies.
• Respiratory distress due to causes other than respiratory distress syndrome (RDS).
• Congenital heart disease.
• Congenital diaphragmatic hernia.
• Pulmonary hypoplasia.
• Chromosomal abnormalities.
• Presence of pneumothorax.
• Lack of informed consent.
• Neonatal seizures presence.
• Postnatal age greater than 6 hours.
• Infants born outside of gestational weeks 24 1/7 - 29 6/7.
• Requirement for invasive mechanical ventilation at enrollment.
• Infants receiving noninvasive respiratory support with an FiO₂ requirement \<0.30.

Sponsors & Collaborators

• Uludag University: lead

Study Sites (5)

Bursa City Hospital

Bursa, Turkey (Türkiye)

RECRUITING

Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine

Bursa, Turkey (Türkiye)

RECRUITING

Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

RECRUITING

Dörtçelik Children's Diseases Hospital

Bursa, Turkey (Türkiye)

RECRUITING

Medicana Bursa Hospital

Bursa, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Kakkilaya V, Gautham KS. Should less invasive surfactant administration (LISA) become routine practice in US neonatal units? Pediatr Res. 2023 Apr;93(5):1188-1198. doi: 10.1038/s41390-022-02265-8. Epub 2022 Aug 19.

  PMID: 35986148 BACKGROUND

• Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.

  PMID: 36863329 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Respiratory Distress Syndrome; Premature Birth

Interventions

poractant alfa; calfactant

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Salih Çağrı Çakır, Associate professor

CONTACT

+90 533 3453739; salihcagri@uludag.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: January 20, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): February 20, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5)