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 @ 6:28 PM
Ignite Modification Date:
2025-12-24 @ 6:28 PM
NCT ID:
NCT04000568
Eligibility Criteria:
Inclusion Criteria:
* preterm birth \< 37 weeks of gestational age
* need of non-invasive respiratory support
* parental consent
Exclusion Criteria:
* Major congenital abnormalities of the cardio-respiratory systems
* Severe Respiratory Failure requiring intubation and mechanical ventilation at the time of the study; pH \< 7.25 pCO2\> 65 mmHg; pulmonary hypertension of the newborn requiring pharmacological treatment (Nitric Oxide, Sildenafil)
* Hypoxic-Ischaemic Encephalopathy, neurological disorders which may compromise the integrity of the neural transmission from the brain to the diaphragm
* Contraindication to orogastric tube insertion (e.g. oesophageal atresia, gastric perforation...)
* Haemodynamic instability requiring inotropic agents
* Any condition that would expose the patient to undue risk as deemed by the attending physician
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
3 Months
Study:
NCT04000568
Study Brief:
Protocol Section:
NCT04000568