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:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT03181958
Eligibility Criteria:
Inclusion Criteria:
* gestational age between 25+0 and 32+6 weeks;
* birth weight more than 600 g;
* supported with any type of endotracheal ventilation;
* Has not had first attempt at extubation(extubation readiness requires fulfilling of all the following criteria: a. Having received at least one loading dose of 20 mg/kg and 5 mg/kg daily maintenance dose of caffeine citrate; b. pH\>7.20 PaCO2\<=60 mmHg (these may be evaluated by arterialized capillary blood gas analysis or appropriately calibrated transcutaneous monitors. Venous blood gas values cannot be used); c. Paw \<=7-8 cmH2O; d. FiO2\<=0.30; e. sufficient spontaneous breathing effort, as per clinical evaluation).;
* Obtained parental consent. Informed consent will be obtained antenatally or upon neonatal intensive care unit admission.;
Exclusion Criteria:
* major congenital anomalies or chromosomal abnormalities;
* Presence of neuromuscular disease;
* Upper respiratory tract abnormalities; ;
* need for surgery known before the first extubation;
* Grade IV-intraventricular haemorrhage (IVH) occurring before the first extubation
* congenital lung diseases or malformations or pulmonary hypoplasia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Minutes
Maximum Age:
1 Month
Study:
NCT03181958
Study Brief:
Protocol Section:
NCT03181958