Actively Recruiting
Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
Led by Uludag University · Updated on 2026-04-28
234
Participants Needed
5
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Born at a participating study center hospital
- Gestational age between 24 1/7 and 29 6/7 weeks (less than 30 0/7 weeks)
- Postnatal age within the first 6 hours of life
- Being on non-invasive respiratory support
- Clinical and radiological signs consistent with respiratory distress syndrome (RDS)
- Need for oxygen concentration (FiO2) greater than 30% to maintain oxygen saturation between 90-94% while on noninvasive respiratory support with at least 6 cmH2O pressure
- Written informed consent from a parent or legal guardian
You will not qualify if you...
- Infants intubated for any reason before surfactant administration
- Severe birth asphyxia with advanced resuscitation after birth, 10-minute Apgar score 5 or less, and arterial blood gas pH less than 7.0 with base excess less than or equal to -12 within the first hour of life
- Major congenital anomalies
- Respiratory distress caused by conditions other than RDS
- Congenital heart disease
- Congenital diaphragmatic hernia
- Pulmonary hypoplasia
- Chromosomal abnormalities
- Presence of pneumothorax
- Lack of informed consent
- Neonatal seizures
- Postnatal age greater than 6 hours
- Infants born outside gestational weeks 24 1/7 to 29 6/7
- Need for invasive mechanical ventilation at enrollment
- Receiving noninvasive respiratory support with oxygen requirement less than 30%
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Bursa City Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
2
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa, Turkey (Türkiye)
Actively Recruiting
3
Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
4
Dörtçelik Children's Diseases Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
5
Medicana Bursa Hospital
Bursa, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Salih Çağrı Çakır, Associate professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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