Respiratory Distress Syndrome in Premature InfantsPhase 4NCT07350018
Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
A Phase 4 study testing Poractant alfa and Calfactant in people with Respiratory Distress Syndrome in Premature Infants and Respiratory Distress Syndrome (RDS), run by Uludag University at 5 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 6 hours
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infants, Respiratory Distress Syndrome (RDS), Surfactant
- What is being tested?
- Poractant alfa and Calfactant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 20 Jan 2026to 20 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Bursa City Hospital
Bursa
Erbu Yarcı, Associate professor, +90 505 729 3482, erbuyarci@yahoo.com
Erbu Yarcı, Associate professor
- Recruiting
Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine
Bursa
Salih Çağrı Çakır, Associate professor, +90 533 3453739, salihcagri@uludag.edu.tr
Fatma Nirgül Köksal, Professor
- Recruiting
Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital
Bursa
İpek Güney Varal, Professor, +90 532 3413389, ipekguneyvaral@gmail.com
İpek Güney Varal, Professor
- Recruiting
Dörtçelik Children's Diseases Hospital
Bursa
Fatma Kocael, Neonatologist, +90 505 678 6875, fatma.irioglu@gmail.com
Fatma İrioğlu, Neonatologist
- Recruiting
Medicana Bursa Hospital
Bursa
Şerif Hamitoğlu, +90 555 5541694, drserif@gmail.com
Şerif Hamitoğlu
About this study
Official title: Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome
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.
Read the detailed description
Respiratory distress syndrome (RDS) remains one of the leading causes of respiratory failure in preterm infants. Surfactant replacement therapy is a cornerstone of RDS management; however, traditional administration through endotracheal intubation and mechanical ventilation may contribute to ventilator-induced lung injury and increase the risk of adverse pulmonary outcomes. With the widespread adoption of non-invasive respiratory support strategies, less-invasive approaches to surfactant administration have gained increasing attention.
Less Invasive Surfactant Administration (LISA) is a technique in which surfactant is delivered directly into the trachea via a thin catheter under direct laryngoscopic visualization. At the same time, the infant continues to breathe spontaneously on noninvasive respiratory support. This method avoids endotracheal intubation and mechanical ventilation and has been associated with reduced need for invasive ventilation and improved respiratory outcomes in preterm infants.
Several surfactant preparations are currently used in neonatal practice. Poractant alfa and calfactant are two commonly administered natural surfactants with differing biochemical composition and dosing characteristics. Although both agents are widely used for the treatment of RDS, data directly comparing their effectiveness when administered via the LISA technique are limited.
This multicenter, prospective, randomized study is designed to compare the clinical efficacy of poractant alfa and calfactant administered using the LISA technique in preterm infants with respiratory distress syndrome. Eligible participants will be preterm infants born at less than 30 weeks' gestation, diagnosed with RDS based on clinical and radiographic criteria, who are spontaneously breathing and receiving noninvasive respiratory support without prior endotracheal intubation.
After enrollment, infants will be randomly assigned to receive either poractant alfa or calfactant via the LISA method. In both groups, surfactant will be administered through a thin catheter inserted into the trachea under direct laryngoscopic visualization while maintaining spontaneous breathing and noninvasive respiratory support. Standard neonatal intensive care practices will be applied throughout the study period in all participating centers.
The primary focus of the study is to compare short-term respiratory outcomes between the two treatment groups. These include the need for endotracheal intubation, the requirement for repeat surfactant administration, and the level and duration of respiratory support within the first 72 hours of life. Secondary outcomes include longer-term clinical outcomes such as the development of bronchopulmonary dysplasia at 36 weeks' postmenstrual age, as well as other neonatal morbidities, including intraventricular hemorrhage, necrotizing enterocolitis, and overall survival to discharge.
By directly comparing poractant alfa and calfactant administered via the LISA technique in a randomized, multicenter setting, this study aims to provide evidence on the optimal surfactant choice for less invasive treatment of RDS in very preterm infants. The findings are expected to inform clinical practice and contribute to the improvement of respiratory management strategies.
- Conditions
- Respiratory Distress Syndrome in Premature Infants, Respiratory Distress Syndrome (RDS), Surfactant
- Being tested
- Poractant alfa, Calfactant
- Keywords
- Respiratory Distress Syndrome, Premature infant, Poractant alfa, Calfactant, surfactant treatment, Less Invasive Surfactant Administration, LISA
- Medical subject headings
- Respiratory Distress Syndrome In Premature Infants, Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poractant alfaDrug
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)
CalfactantDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Calfactant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours after birth.
Secondary outcomes (11)
Need for Repeat Surfactant Administration
The requirement for repeat doses of surfactant after the initial LISA procedure in preterm infants treated with calfactant or poractant alfa.
Measured: Up to 72 hours after birth.
Adverse Events During Surfactant Administration
The occurrence of adverse events during surfactant administration via LISA, including apnea, bradycardia, oxygen desaturation, surfactant reflux, coughing, laryngospasm, and vomiting.
Measured: During the surfactant administration and up to 72 hours after birth.
Bronchopulmonary dysplasia
The incidence of bronchopulmonary dysplasia at 36 weeks' postmenstrual age in preterm infants receiving calfactant or poractant alfa via LISA.
Measured: At 36 weeks' postmenstrual age or discharge, whichever occurred first.
Retinopathy of Prematurity
The incidence of retinopathy of prematurity (ROP) in preterm infants receiving calfactant or poractant alfa via LISA.
Measured: From birth until discharge, assessed up to 44 weeks' postmenstrual age.
Patent Ductus Arteriosus
The incidence of patent ductus arteriosus requiring medical or surgical treatment in preterm infants treated with calfactant or poractant alfa via LISA.
Measured: 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.
Air Leak Syndromes
The occurrence of air leak syndromes (including pneumothorax, pulmonary interstitial emphysema, and pneumomediastinum) in preterm infants receiving calfactant or poractant alfa via LISA.
Measured: Up to 7 days after birth.
Duration of Respiratory Support
Total duration of invasive and noninvasive mechanical ventilation.
Measured: From birth until discontinuation of respiratory support or discharge, whichever occurs first. (Through study completion, an average of 1 year.)
Length of Hospital Stay
Length of hospital stay in days for preterm infants treated with calfactant or poractant alfa via LISA.
Measured: From birth until discharge. (Through study completion, an average of 1 year.)
Mortality
All-cause mortality before hospital discharge.
Measured: From the date of randomization until the date of death from any cause or the date of discharge, whichever came first. (Through study completion, an average of 1 year.)
Intraventricular Hemorrhage
The incidence of intraventricular hemorrhage (IVH) in preterm infants receiving calfactant or poractant alfa via LISA.
Measured: Up to the 7th day after birth.
Necrotizing Enterocolitis
The incidence of necrotizing enterocolitis (NEC) in preterm infants receiving calfactant or poractant alfa via LISA.
Measured: From birth until the date of the first documented necrotizing enterocolitis or the date of discharge, whichever came first, assessed up to 36 weeks' postmenstrual age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start20 Jan 2026
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome in Premature InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salih Çağrı Çakır, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350018
- Sponsor's protocol ID
- 2025-20/9
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: I am not authorized to share patient data.
Publications
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.
PubMed 35986148Sweet 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.
PubMed 36863329
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07350018
- Acronym / sponsor ID
- 2025-20/9
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Respiratory distress syndrome (RDS) remains one of the leading causes of respiratory failure in preterm infants. Surfactant replacement therapy is a cornerstone of RDS management; however, traditional administration through endotracheal intubation and mechanical ventilation may contribute to ventilator-induced lung injury and increase the risk of adverse pulmonary outcomes. With the widespread adoption of non-invasive respiratory support strategies, less-invasive approaches to surfactant administration have gained increasing attention.
Less Invasive Surfactant Administration (LISA) is a technique in which surfactant is delivered directly into the trachea via a thin catheter under direct laryngoscopic visualization. At the same time, the infant continues to breathe spontaneously on noninvasive respiratory support. This method avoids endotracheal intubation and mechanical ventilation and has been associated with reduced need for invasive ventilation and improved respiratory outcomes in preterm infants.
Several surfactant preparations are currently used in neonatal practice. Poractant alfa and calfactant are two commonly administered natural surfactants with differing biochemical composition and dosing characteristics. Although both agents are widely used for the treatment of RDS, data directly comparing their effectiveness when administered via the LISA technique are limited.
This multicenter, prospective, randomized study is designed to compare the clinical efficacy of poractant alfa and calfactant administered using the LISA technique in preterm infants with respiratory distress syndrome. Eligible participants will be preterm infants born at less than 30 weeks' gestation, diagnosed with RDS based on clinical and radiographic criteria, who are spontaneously breathing and receiving noninvasive respiratory support without prior endotracheal intubation.
After enrollment, infants will be randomly assigned to receive either poractant alfa or calfactant via the LISA method. In both groups, surfactant will be administered through a thin catheter inserted into the trachea under direct laryngoscopic visualization while maintaining spontaneous breathing and noninvasive respiratory support. Standard neonatal intensive care practices will be applied throughout the study period in all participating centers.
The primary focus of the study is to compare short-term respiratory outcomes between the two treatment groups. These include the need for endotracheal intubation, the requirement for repeat surfactant administration, and the level and duration of respiratory support within the first 72 hours of life. Secondary outcomes include longer-term clinical outcomes such as the development of bronchopulmonary dysplasia at 36 weeks' postmenstrual age, as well as other neonatal morbidities, including intraventricular hemorrhage, necrotizing enterocolitis, and overall survival to discharge.
By directly comparing poractant alfa and calfactant administered via the LISA technique in a randomized, multicenter setting, this study aims to provide evidence on the optimal surfactant choice for less invasive treatment of RDS in very preterm infants. The findings are expected to inform clinical practice and contribute to the improvement of respiratory management strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poractant alfa (LISA) | Active comparator | Drug: Poractant alfaPreterm infants with respiratory distress syndrome (RDS) will receive poractant alfa via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support. |
| Calfactant (LISA) | Active comparator | Drug: CalfactantPreterm infants with respiratory distress syndrome (RDS) will receive calfactant via the Less Invasive Surfactant Administration (LISA) technique while on noninvasive respiratory support. |
Who may qualify
- Ages
- 0 to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poractant alfaPoractant 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 | Poractant alfa (LISA) |
| CalfactantCalfactant 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) | Drug | Calfactant (LISA) |
Primary outcome
Need for endotracheal intubation within the first 72 hours of life
Time frame: Up to 72 hours after birth.
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.
11 secondary outcomes
Need for Repeat Surfactant Administration
Time frame: Up to 72 hours after birth.
Adverse Events During Surfactant Administration
Time frame: During the surfactant administration and up to 72 hours after birth.
Bronchopulmonary dysplasia
Time frame: At 36 weeks' postmenstrual age or discharge, whichever occurred first.
Retinopathy of Prematurity
Time frame: From birth until discharge, assessed up to 44 weeks' postmenstrual age.
Patent Ductus Arteriosus
Time frame: 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.
Air Leak Syndromes
Time frame: Up to 7 days after birth.
Duration of Respiratory Support
Time frame: From birth until discontinuation of respiratory support or discharge, whichever occurs first. (Through study completion, an average of 1 year.)
Length of Hospital Stay
Time frame: From birth until discharge. (Through study completion, an average of 1 year.)
Mortality
Time frame: From the date of randomization until the date of death from any cause or the date of discharge, whichever came first. (Through study completion, an average of 1 year.)
Intraventricular Hemorrhage
Time frame: Up to the 7th day after birth.
Necrotizing Enterocolitis
Time frame: From birth until the date of the first documented necrotizing enterocolitis or the date of discharge, whichever came first, assessed up to 36 weeks' postmenstrual age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 35986148Kakkilaya 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.
- Background: PubMed 36863329Sweet 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.
- Individual participant dataSharing planned: No. I am not authorized to share patient data.
Related trials for Respiratory Distress Syndrome in Premature Infants
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
Respiratory Distress Syndrome, Newborn, Infant, Premature
Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
RecruitingPhase 3
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
Respiratory Distress Syndrome, Pre-term Infants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Poractant alfa and Calfactant in people with Respiratory Distress Syndrome in Premature Infants and Respiratory Distress Syndrome (RDS), run by Uludag University at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salih Çağrı Çakır, Associate professor (+90 533 3453739, salihcagri@uludag.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need for endotracheal intubation within the first 72 hours of life (time frame: Up to 72 hours after birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07350018, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.