Servo-n HFOV Study: Safety and Performance in Neonates and Infants

Inclusion Criteria:

• Provision of written informed consent by the patient's legally designatedrepresentative(s) (may be obtained as deferred consent up to 24 hours after HFOVinitiation: valid for both elective and rescue HFOV patients)

• Patients eligible for HFOV ventilation with Servo-n:

• Patient is either switched from conventional mechanical ventilation or HFOVwith other device to Servo-n HFOV based on clinicians judgement (rescue HFOV).Note: the reason for the switch has to be that the patient failed to oxygenateor ventilate adequately with CMV or the other HFOV device ; OR

• Patient was prior without or with any type of non-invasive respiratory supportand is put on invasive HFOV treatment based on clinicians judgement (electiveHFOV)

• Patient has not already been on HFOV in a previous episode, unless the etiology ofrespiratory failure has changed during the same hospitalisation. For example,initial HFOV treatment for RDS, second HFOV episode of NARDS of any etiology (willbe enrolled as a new patient case). NOTE1: When a patient failed weaning onconventional ventilation within 6 hours, requiring to be put back on HFOV it will becounted as one HFOV episode (weaning failure) NOTE2: When a patient is temporarilyput on conventional ventilation for transport or a surgical intervention, and willbe put back to HFOV afterwards, it will be counted as one HFOV episode (HFOVpaused).

• Patient has a body weight from 0.3 to 8.0 kg

Exclusion Criteria:

• Diagnosis of congenital diaphragmatic hernia

• Severe cardiac anomaly expected to need corrective surgery or catheter-basedintervention within 30 days from birth

• Cyanotic heart disease

• Intracranial hemorrhage, Grade III or IV

• Congenital malformations with the exception of isolated lung hypoplasia

• Persistent pulmonary hypertension (PPHN) with a documented shunt on the level of theforamen ovale

• Bronchopulmonary Dysplasia (BPD) /Chronic Lung Disease (CLD)