Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT05024435
Eligibility Criteria:
Inclusion Criteria:
* Preterm infants born less than 37 weeks of gestation
* Treating physician in charge of admission decides to administer intratracheal surfactant via standardized institution- LISA protocol (regardless of this study) (see Supplement file 1)
* Written informed consent signed by caregivers or legal representative to participate
Exclusion Criteria:
* Refusal to participate in study or not providing written informed consent by caregivers/parents
* Treating physician decides to use different route of surfactant administration or does not adhere to LISA protocol.
* Rupture of membranes (ROM) at less than 22 weeks of gestation or more than 6 weeks before birth
* Estimated birth weight \< 3rd percentile using 2013 Fenton growth trajectories
* Twins with feto-fetal transfusion syndrome (FFTS) and FFTS being the cause of premature delivery
* Contraindications listed in the LISAcath® or Nasogastric Tube manual (esophageal/pharyngeal varices or other vascular lesions, esophageal/pharyngeal tumor, nasal fracture, skull fracture, known allergy to material)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05024435
Study Brief:
Protocol Section:
NCT05024435