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Compares treatment options for Respiratory Distress Syndrome in Premature Infants
Official title Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT07350018
What this study is testing
What is Poractant alfa?
Poractant alfa is an investigational medicine, being studied as a potential treatment for respiratory distress syndrome in premature infants.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 6
You may be able to join 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).
You likely can't join 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...
- Presence of major congenital anomalies.
- Respiratory distress due to causes other than respiratory distress syndrome (RDS).
- Congenital heart disease.
- Congenital diaphragmatic hernia.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bursa, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 hours to 6 hours. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bursa, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.